Evaluation of Multielectrode Phased RF Technology in Persistent Atrial Fibrillation
Phase: NA
Conditions: Persistent Atrial Fibrillation
Sponsor: Medtronic Cardiac Ablation Solutions

 
 
VICTORY AF 
Evaluation of Multielectrode Phased RF Technology in Persistent Atrial Fibrillation 
Clinical Investigation Plan Version 6.0 
21 NOV 2014 
NCT01693120 

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7.5
Data collection.......................................................................................................30
7.6
Subject visit schedule ............................................................................................32
7.7
Study procedure details .........................................................................................33
7.8
Enrollment and Baseline........................................................................................36
7.9
Phased RF Ablation Procedure..............................................................................37
7.9.1
Pre-procedure evaluation
37
7.9.2
Procedure preparation
37
7.9.3
PVAC or PVAC GOLD catheter introduction
38
7.9.4
PVAC or PVAC GOLD pulmonary vein ablation
38
7.9.5
MASC catheter introduction
38
7.9.6
MASC septal ablation
38
7.9.7
MAAC catheter introduction
38
7.9.8
MAAC CFAE ablation
39
7.9.9
Post-procedure evaluation
39
7.10
Discharge follow-up ...............................................................................................39
7.11
30 day follow-up ....................................................................................................40
7.12
3 month follow-up ..................................................................................................40
7.13
6 month follow-up ..................................................................................................41
7.14
Unscheduled follow-up visits..................................................................................41
7.15
Permissible Retreatment Ablation Procedure.........................................................42
7.16
Study Exit ..............................................................................................................42
7.16.1
Lost to follow-up
43
7.16.2
Subject-initiated withdrawal
43
7.16.3
Early study suspension or termination
43
7.16.4
Early investigation site suspension or termination
43
7.17
Study Closure........................................................................................................43
7.18
Concomitant Medications.......................................................................................43
8.
INVESTIGATIONAL DEVICE/SOFTWARE STORAGE, HANDLING AND 
TRACEABILITY............................................................................................................ 44
8.1
Final product disposition ........................................................................................44
9.
STUDY DEVIATIONS.......................................................................................... 45
10.
ADVERSE EVENTS AND DEVICE DEFICIENCIES............................................ 46
10.1
Adverse Event and Device Deficiency Assessment ...............................................47
10.2
Adverse Event and Device Deficiency Definitions, Classification and ....................48
Reporting ............................................................................................................................48
10.3
Clinical Events Committee Review ........................................................................55
10.4
Steering Committee (SC).......................................................................................56
10.5
Data Monitoring Committee (DMC)........................................................................56
10.6
Market Released Event Reporting .........................................................................57

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LISTING OF TABLES
Table 1: Study sponsor contact information.........................................................................7
Table 2: CRO and core lab information .................................................................................8
Table 3: Steering Committee contact information................................................................9
Table 4: System component information ............................................................................16
Table 5: Protocol defined stroke..........................................................................................21
Table 6: Data collection and study procedure requirements at subject visits .................31
Table 7: Visit Windows .........................................................................................................32
Table 9: Unavoidable Adverse Events Related to Ablation Procedure .............................47
Table 10: Adverse Event and Device Deficiency Definitions .............................................49
Table 11: Adverse Event Classification Responsibilities...................................................53
Table 12: Death Classification Definitions ..........................................................................55
Table 13: Adverse Event and Device Deficiency Reporting Requirements ......................58
Table 14: Potential Risks and Risk Minimization................................................................61
Table 15: Investigator reports applicable for all geographies per Medtronic requirements
...............................................................................................................................................84
Table 16: Investigator reports applicable to the United States per FDA regulations .......84
Table 17: Investigator reports applicable to Europe per ISO 14155..................................85
Table 18: Investigator Reports Applicable to Canada ........................................................85
Table 20: Sponsor reports for Europe.................................................................................87
Table 21: Sponsor reports for the United States ................................................................88
Table 22: Sponsor reports for Canada ................................................................................89

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1.
STUDY SUMMARY
1.1
Study Purpose
VICTORY AF is an IDE, prospective global, multi-center, single arm, investigational 
clinical study. The purpose of this clinical study is to evaluate the risk of procedure and/or 
device related strokes in subjects with persistent or long-standing persistent atrial 
fibrillation (AF) undergoing ablation with the Phased RF System.
1.2
Phased RF System Description
The Medtronic Phased RF System is intended to be used for mapping intracardiac 
electrograms and to deliver precise, temperature controlled radio frequency (RF) ablation 
therapy within the left atrium of the heart for the treatment of atrial fibrillation. The 
Phased RF System includes the GENius Multi Channel Radio Frequency Ablation 
Generator and three anatomically designed, multi-electrode catheters:

Pulmonary Vein Ablation Catheter (PVAC) or Pulmonary Vein Ablation Catheter 
GOLD (PVAC GOLD)

Multi-Array Septal Catheter (MASC)

Multi-Array Ablation Catheter (MAAC)
1.3
Study Description
A maximum of 420 subjects will be enrolled in the study to ensure 300 subjects can be
evaluated for the primary safety endpoint. Subjects will be followed for 6 months post 
index or reablation (if reablation required) procedure for the primary safety objective. The 
primary safety objective will be evaluated after at least 300 ablated subjects complete 
the 30 day post index or reablation procedure visit and have had the opportunity for a 
reablation procedure. The study may stop early for futility if more than 6 procedure 
and/or device related strokes occur within the 30 day peri-procedural period.
Study subjects from all geographies will be followed for 6 months following their final
ablation procedure, or official study closure defined as when Medtronic and/or regulatory 
requirements have been satisfied per the Clinical Investigational Plan (CIP), whichever 
occurs first.
Expected total study duration is approximately 36 months, representing 24 months of
enrollment and up to 12 months of subject follow-up.
1.4
Study Objectives
1.4.1
Primary Objective
Demonstrate that the observed incidence of procedure and/or device related incidence of 
new stroke (excludes transient ischemic attack) within 30 days of an ablation procedure 
(index or reablation) with the Phased RF System is less than 1.8% with observed upper 
confidence boundary that is less than 3.5%.

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4.
Willingness, ability and commitment to participate in baseline and follow-
up evaluations for the full length of the study
1.6
Exclusion Criteria
1.
Structural heart disease of clinical significance including:

Previous cardiac surgery (e.g. mitral valve repair) except CABG

NYHA Class III or IV CHF and/or documented ejection fraction <40% 
measured by acceptable cardiac testing (e.g. TEE)

Left atrial diameter of >55mm

3+ mitral or aortic valvular heart disease

Stable/unstable angina or ongoing myocardial ischemia

Myocardial infarction (MI) within three months of enrollment

Congenital heart disease other than ASD or PFO without a right to 
left shunt where the underlying abnormality increases the risk of an 
ablative procedure 

Prior ASD or PFO closure with a device using a percutaneous 
approach

Hypertrophic cardiomyopathy (LV septal wall thickness >1.5 cm)

Pulmonary hypertension (mean or systolic PA pressure >50mm Hg 
on Doppler echo)
2.
Any prior ablation for atrial fibrillation in the left atrium
3.
Enrollment in any other ongoing arrhythmia study protocol 
4.
Any ventricular tachyarrhythmia currently being treated where the 
arrhythmia or the management may interfere with this study 
5.
Active infection or sepsis
6.
History of symptomatic cerebral vascular disease such as clinical stroke, 
TIA, or other diseases that manifest stroke-like symptoms (e.g. multiple 
sclerosis or seizure disorders)
7.
Pregnancy or lactation
8.
Untreatable allergy to contrast media
9.
Any diagnosis of atrial fibrillation secondary to electrolyte imbalance, 
thyroid disease, or any other reversible or non-cardiovascular causes
10.
Contraindicated for use of oral vitamin K antagonist (VKA e.g. warfarin)
anticoagulation (e.g. history of blood clotting disorders)

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
CFAEs and high frequency intracardiac electrogram amplitudes were mapped and 
ablated as necessary with Phased RF catheters AND

Sinus rhythm is restored at the end of the ablation procedure (with or without 
cardioversion)
1.11 Sample Size
Up to 420 subjects with be enrolled to ensure that at least 300 subjects receive an index 
Phased RF ablation procedure and can be evaluated for the primary safety endpoint.  
Subject enrollment will stop once approximately 300 evaluable subjects are accrued.  
1.12 Centers 
The VICTORY AF study is expected to be conducted at up to 55 sites in Europe, Canada, 
and the United States (US).  
1.13 Study Design
1.14 Anticoagulation Protocol

Subjects must be on continuous vitamin K antagonist (VKA) (e.g. Warfarin/Coumadin) 
anticoagulation therapy throughout the VICTORY AF IDE study:
o
Baseline

On vitamin K antagonist (VKA) and two therapeutic INR readings within 30 days 
prior to index ablation procedure
o
Procedure

Continue therapeutic vitamin K antagonist anticoagulation

INR must be 2-3.5 on day of procedure

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
Prior to transseptal puncture administer heparin bolus and start continuous 
heparin infusion to maintain ACT at or above 350 seconds

Maintain continuous drip/flush of sheath when placed in left atrium

Do not ablate with the Phased RF catheters unless ACT levels are at or above 
350 seconds.

Continue ACT measurements every 20-30 minutes thereafter until all Phased RF 
catheters are removed from body.
o
Post-procedure

Resume vitamin K antagonist (VKA) anticoagulation per subjects existing dose
schedule

Continue therapeutic vitamin K antagonist anticoagulation through end of study
2.
INTRODUCTION
2.1
Study purpose
Medtronic, Inc. is sponsoring the Evaluation of Multielectrode Phased RF Technology in 
Persistent Atrial Fibrillation (VICTORY AF) ablation study, prospective, unblinded, multi-center, 
investigational, global, clinical study. The purpose of this clinical study is to evaluate the risk of 
procedure and/or device related strokes in subjects with persistent or long-standing persistent 
atrial fibrillation (AF) undergoing ablation with the GENius Multi Channel Radio Frequency 
Ablation Generator, Pulmonary Vein Ablation Catheter (PVAC) or Pulmonary Vein Ablation 
Catheter GOLD (PVAC GOLD), the Multi-Array Septal Catheter (MASC), and the Multi-Array 
Ablation Catheter (MAAC) Catheter System.
2.2
Study description
The study is expected to be conducted at up to 55 centers located in Europe, Canada and the 
United States to support US Food and Drug Administration (FDA) marketing application. A 
maximum of 420 subjects will be enrolled in the study to ensure 300 subjects can be evaluated 
for the primary safety endpoint. Subjects will be followed for 30 days post reablation (if 
reablation required) procedure or 6 months post index procedure (if no reablation procedure 
required) for the primary safety objective.  The primary safety objective will be evaluated after 
at least 300 ablated subjects complete the 30 day post index or reablation procedure visit and 
have had the opportunity for a reablation visit.  Alternatively, the study may stop early for futility 
if more than 6 procedure and/or device related strokes occur within the 30 day peri-procedural 
period prior to completing enrollment.
Study subjects from all geographies will be followed for 6 months following their final ablation 
procedure, or official study closure defined as when Medtronic and/or regulatory requirements 
have been satisfied per the Clinical Investigational Plan (CIP), whichever occurs first. 
Accordingly, the expected total study duration is approximately 36 months, representing 24
months of enrollment and up to 12 months of subject follow-up.

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4.2
Labeling
Since the devices used in the VICTORY AF study are market-released in Europe, original 
labeling will be used unless local regulations require otherwise. Labeling of CE-marked
devices will follow local language requirements.
In Canada, Investigational products labeled as required under Subsections 86(c) and 86(d) of 
the Medical Devices Regulations. 
5.
REGULATORY COMPLIANCE
The VICTORY AF clinical study is an Investigational Device Exemption (IDE) study in the 
United States.
The VICTORY AF clinical study is designed to reflect good clinical practice principles. These 
include the protection of the rights, safety and well-being of human subjects, controls to 
ensure the scientific conduct, credibility and data integrity of the clinical investigation, and the 
definition of responsibilities of the sponsor and investigators.
The study will be conducted according to the Declaration of Helsinki, this Clinical 
Investigation Plan (CIP) and federal, national and local laws, regulations, standards, and 
requirements of the countries/geographies where the study is being conducted. The 
principles of the Declaration of Helsinki are implemented in this study by means of the 
Patient Informed Consent (IC) process, Institutional Review Board (IRB) or Medical Ethics 
Committee (MEC) approval, study training, clinical trial registration, pre-clinical testing, risk 
benefit assessment, publication policy, etc.
In the United States, this study will be conducted in compliance with relevant local laws 
which are US FDA 21 CFR parts

11: Electronic Records; Electronic Signatures

50: Protection of Human Subjects

54: Financial Disclosure by Clinical Investigators

56: Institutional Review Boards

812: Investigational Device Exemptions
The Phased RF System is approved for use in the EEA (European Economic Area). The study 
will be conducted in accordance with local law and the transposition of the applicable 
requirements of the Medical Device Directive in local law. In regions where the system is 
market released, the system will be used in the manner for which it was intended and therefore 
in Europe the VICTORY AF clinical study is a post market study.
In Canada, the study will be conducted in accordance with Canada Medical Device 
Regulations, SOR/98-282; 77, 59, Mandatory Problem Reporting 59(1), 59(2), 60 (1))

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This study will be publicly registered prior to first enrollment in accordance with the
2007 Food and Drug Administration Amendments Act (FDAAA) and Declaration of
Helsinki on http://clinicaltrials.gov/.
In addition to following the governing regulations noted above, any additional requirements of 
the individual study center’s IRB/MEC or regulatory authority will also be followed by the study 
center where applicable.
Approval of the CIP or CIP amendments is required from the following groups prior to any 
study procedures at a study center: Medtronic, geography-specific regulatory authorities (if 
regulatory approval is required) and an independent medical ethics committee or institutional 
review board.
6.
METHODOLOGY
6.1
Study design
This study is a prospective, unblinded, multi-center, investigational (U.S. and Canada), global, 
clinical study designed to evaluate the procedure and/or device related stroke rate within 30 
days after an ablation procedure with the Medtronic Phased RF System. In regions where the 
system is market released, the system will be used in the manner for which it was intended.
The primary safety objective will be evaluated after at least 300 ablated subjects complete the 
30 day post index or reablation procedure visit and have had the opportunity for a reablation 
visit.  The study may stop early for futility if more than six (6) procedure and/or device related 
strokes occur prior to completing enrollment.
6.2
Study objectives
6.2.1
Primary safety objective
Demonstrate that the observed incidence of procedure and/or device related incidence 
of new stroke (excludes transient ischemic attack) within 30 days of an ablation 
procedure (index or reablation) with the Phased RF System is less than 1.8% with 
observed upper confidence boundary that is less than 3.5%.  
The definition of stroke is provided in the Table below. To meet the primary endpoint an 
event must meet all of the criteria in Table 5 below as determined by the clinical events 
committee (CEC).

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6.2.2
Secondary effectiveness objectives
6.2.2.1
6-Month Post-Procedural Effectiveness
Characterize the 6-month post-procedural effectiveness. 
6-Month effectiveness will be defined as:

Acute procedural success, AND

> 90% reduction in clinically significant AF/AFL by 48-hour ambulatory ECG 
monitor. Clinically significant AF/AFL is defined as; any AF/AFL episode lasting 
longer than 10 consecutive minutes in duration, AND

Off amiodarone for at least 90 days and off all other class I and class III 
antiarrhythmic drugs for at least 60 days prior to the 6-month ambulatory ECG 
monitor, AND

Free from DC cardioversion for AF for at least 60 days prior to the 6-month 
ambulatory ECG monitor
Only those subjects that have completed both a baseline and 6-month 48 hour 
ambulatory ECG monitor or are 6-month effectiveness failures based on other criteria
will be included in the PMA effectiveness analysis cohort. Two ablation procedures with 
the Phased RF system are allowed to achieve procedural effectiveness.
6.2.2.2
Acute procedure success
Characterize acute procedural effectiveness.  
Acute procedural success will be defined as:

Only Phased RF catheters used in the left atrium to achieve procedure success 
AND

All targeted pulmonary veins were isolated (entrance block) AND

CFAEs and high frequency intracardiac electrogram amplitudes were mapped and 
ablated as necessary with Phased RF catheters AND

Sinus rhythm is restored at the end of the ablation procedure (with or without 
cardioversion)
6.2.3
Secondary safety objective
6.2.3.1
Pulmonary vein stenosis (PVS)
Characterize the incidence of PVS 3 months post ablation procedure as determined by 
MRI or CT scan.
This objective will be evaluated in a subset of 100 subjects.

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6.3.1
Inclusion criteria
1. History of symptomatic persistent or long-standing persistent atrial fibrillation defined 
as:

Persistent AF: sustained AF lasting > 7 days but no more than 1 year, or sustained 
AF lasting < 7 days but necessitating pharmacologic or electrical cardioversion; OR

Long-standing persistent AF: sustained AF lasting at least 1 year but no more than
4 years in duration.
AND

Continuous AF as demonstrated on a 48-hour ambulatory ECG monitor at baseline
AND

AF symptoms defined as the manifestation of:

Palpitations

Fatigue

Exertional dyspnea

Increased intolerance to routine activities (exercise intolerance)
2. Age 18-75 years
3. Failure of at least one class I or III anti-arrhythmic drug (AAD)
4. Willingness, ability and commitment to participate in baseline and follow-up evaluations 
for the full length of the study
6.3.2
Exclusion criteria
1. Structural heart disease of clinical significance including:

Previous cardiac surgery (e.g. mitral valve repair) except CABG

NYHA Class III or IV CHF and/or documented ejection fraction <40% measured 
by acceptable cardiac testing (e.g. TEE)

Left atrial diameter of >55mm

3+ mitral or aortic valvular heart disease

Stable/unstable angina or ongoing myocardial ischemia

Myocardial infarction (MI) within three months of enrollment

Congenital heart disease other than ASD or PFO without a right to left shunt
where the underlying abnormality increases the risk of an ablative procedure 

Prior ASD or PFO closure with a device using a percutaneous approach

Hypertrophic cardiomyopathy (LV septal wall thickness >1.5 cm)

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
Pulmonary hypertension (mean or systolic PA pressure >50mm Hg on Doppler 
echo)
2. Any prior ablation for atrial fibrillation in the left atrium
3. Enrollment in any other ongoing arrhythmia study protocol 
4. Any ventricular tachyarrhythmia currently being treated where the arrhythmia or the 
management may interfere with this study 
5. Active infection or sepsis
6. History of symptomatic cerebral vascular disease such as clinical stroke, TIA or other 
diseases that manifest stroke-like symptoms (e.g. multiple sclerosis or seizure 
disorders)   
7. Pregnancy or lactation
8. Untreatable allergy to contrast media
9. Any diagnosis of atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or 
any other reversible or non-cardiovascular causes
10. Contraindicated for use of oral VKA (e.g. warfarin) anticoagulation (e.g. history of blood 
clotting disorders)
11. Known sensitivities to heparin
12. Severe COPD (defined as an FEV1 <1) 
13. Severe co morbidity or poor general physical/mental health that, in the opinion of the 
Investigator, will not allow the subject to be a good study candidate (e.g. other disease 
processes like recent history of renal disease with GFR <30, recent history of cancer 
treatment, diminished mental capacity, substance abuse, shortened life expectancy, 
etc.)
14. Contraindicated to MRI
15. Any invasive cardiovascular procedure performed or planned within the 3 month
periods  before and/or after the ablation procedure
6.4
Minimization of Bias
Selection of subjects, treatment of subjects, and evaluation of study data are potential 
sources of bias.  Methods incorporated in the study design to minimize potential bias 
include (but are not limited to):

Subjects will be screened to confirm eligibility for enrollment with defined 
inclusion/exclusion criteria prior to enrollment.

Subjects will be selected randomly (excluding the first enrolled subject at each 
center) for evaluating the incidence of 
 pulmonary vein stenosis.

Demographics and medical history will be collected at baseline in order to later 
assess possible characteristics that may influence study endpoints.

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with the sites to develop strategies to improve the participation of women in this study 
that may include, but are not limited to: tailored communication strategies, inclusion of 
health care practitioners to help with recruitment, monetary incentives, flexibility of follow 
up schedule, and reviewing screening logs to identify trends that are inhibiting enrollment 
of women.
Prior to performing study related activities, all local regulatory requirements shall be 
fulfilled, including, but not limited to the following: IRB/MEC approval of the current 
version of the CIP and Patient Informed Consent form, regulatory authority approval or 
notification as required per local law, fully executed Clinical Trial Agreement (CTA), 
Financial Disclosure, investigator Curriculum Vitae (CV), Delegated Task List (DTL) and 
documentation of study training.  In addition, all participating site staff must be trained on 
the current version of the CIP and must be delegated by the principal investigator to 
perform study related activities.  Medtronic will provide each study center with written 
documentation of study center/investigator readiness, this letter must be received prior to 
subject enrollment.
7.3
Equipment requirements
The following center-provided equipment must be available at each center to support 
study activities:

E7506 Valley lab patient return electrodes (2 per subject ablation)

MRI system 

CT scanner

ACT analyzer capable of providing measurements every 10 minutes*
*NOTE: ACT analyzer calibration records must be made available for sponsor review
prior to each Phased RF ablation procedure.
7.4
Patient informed consent process
Patient informed consent is defined as legally effective, documented confirmation of a 
subject’s (or their legally authorized representative or guardian) voluntary agreement to 
participate in a particular clinical study after information has been given to the subject on 
all aspects of the clinical study that are relevant to the subject’s decision to participate. 
This process includes obtaining a Consent and a/an Authorization to Use and Disclose 
Personal Health Information/Research Authorization/other privacy language as required 
by law that has been approved by Competent Authorities (CA), the investigational 
center’s Medical Ethics Committee (MEC), Institutional Review Board (IRB), or Head of 
Medical Institution and signed and dated by the subject (or their legally authorized 
representative or guardian). A subject may only consent after information has been given 
to the subject on all aspects of the clinical investigation that are relevant to the subject’s 
decision to participate.
Prior to enrolling subjects, each investigational center’s MEC, IRB, or Head of Medical
Institution will be required to approve the Consent Form (CF), and Authorization to Use 

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and Disclose Personal Health Information/Research Authorization/other privacy 
language as required by law.  The document(s) must be controlled (i.e. versioned and/or 
dated) to ensure it is clear which version(s) were approved by the (MEC) or (IRB), or 
Head of Medical Institution.  Any adaptation of the sample Consent Form must be 
reviewed by Medtronic and the MEC or IRB, or Head of Medical Institution reviewing the 
application prior to enrolling subjects. 
Prior to initiation of any study-specific procedures, patient informed consent must be 
obtained from the subject (or their legally authorized representative or guardian). 
Likewise, privacy or health information protection regulation in other geographies may 
require subjects to sign additional forms to authorize centers to submit subject 
information to the study sponsor. The Consent Form and Authorization to Use and 
Disclose Personal Health Information/Research Authorization/other privacy language as 
required by law must be given to the subject (or their legally authorized representative or 
guardian) in a language he/she is able to read and understand. The process of patient 
informed consent must not be conducted using coercion or undue improper influence on 
or inducement of the subject to participate by the investigator or other center personnel.
The process of obtaining patient informed consent shall:

Not waive or appear to waive subject’s legal rights

Use language that is non-technical and understandable to the subject

Provide ample time for the subject to read and understand the informed consent 
form and to ask questions, receive answers and consider participation

Include a personally dated signature of the subject acknowledging that their 
participation in the study is voluntary

EEA only: Include a personally dated signature by the principal investigator or 
authorized designee responsible for conducting the informed consent process
If the Consent Form is obtained the same day the subject begins participating in study-
related procedures, it must be documented in the subject’s case history that consent was 
obtained prior to participation in any study-related procedures. It is best practice for the 
informed consent process to be documented in the subject’s case history, regardless of 
circumstance.
In the event a Legally Authorized Representative or guardian is utilized, copy of this legal 
delegation must be retained in the subject’s records. In the event the subject cannot read 
and/or write, witnessed (impartial third party) patient informed consent will be allowed, 
provided detailed documentation of the process is recorded in the subject’s case history 
and the witness signs and dates the patient informed consent. The subject should “make 
his mark” (sign or otherwise physically mark the document so as to indicate consent) on 
the ICF as well. The Consent Form should document the method used for 
communication with the prospective subject and the specific means by which the 
prospective subject communicated agreement to participate in the study. 
The original or a copy of the signed Consent Form must be filed in the hospital/clinical 
chart and with the subject’s study documents. A copy of the signed and dated Consent 

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Form and signed Authorization to Use and Disclose Personal Health 
Information/Research Authorization/other privacy language as required by law must be 
provided to the subject.  
The Consent Form and Authorization to Use and Disclose Personal Health 
Information/Research Authorization/other privacy language as required by law must be 
available for monitoring and auditing. 
Any changes to a previously approved Informed Consent Form throughout the course of 
the study must be approved by the MEC or IRB, or Head of Medical Institution reviewing 
the application before being used to consent a prospective study subject. The MEC or 
IRB, or Head of Medical Institution –approved Consent Form must also be submitted to 
Medtronic for review and approval. The document(s) must be controlled (i.e. versioned 
and/or dated) to ensure it is clear which version(s) were approved by the Medical Ethics 
Committee (MEC) or Institutional Review Board (IRB), or Head of Medical Institution. All 
important new information should be provided to new and existing subjects throughout 
the study. For existing subjects, the informed consent process as described above needs 
to be repeated for significant changes as determined by the MEC, IRB or Head of 
Medical Institution.
7.5
Data collection
Clinical data is collected at designated time points throughout the study. Data will be 
collected using an electronic data management system for clinical studies. Data will be 
stored in a secure, password-protected database which will be backed up nightly. Data 
will be reviewed using programmed and manual data checks. Data queries will be made 
available to study centers for resolution. Study management reports may be generated 
by Medtronic to monitor data quality and study progress. At the end of the study, the data 
will be frozen and retained indefinitely by Medtronic. Data collection requirements are 
summarized in Table 6 below.

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Table 6: Data collection and study procedure requirements at subject visits
Ablation 
Procedure
Repeat Ablation 
Procedure (1-180 days)
30 day
3 month
6  month
Unscheduled 
Baseline
Procedure
Post-procedure
Discharge
Baseline
Procedure
Post-procedure
Discharge
Consent
X
Incl/Excl Criteria
X
History
X
Physical exam
X(11)
X
X
X
X
X
X
X
Pregnancy Screen (if 
applicable per local
requirement)
X
Standard neurologic 
evaluation (performed 
by neurologist)
X
X
X
X
X
X(10)
X(10)
X
Concomitant 
medications
X
X
X
X
X
X
X
X
X
Arrhythmic Sx review
X
X
X
X
X
X
12 lead ECG
X(11)
X
X
X
X
X
X
X
Cardioversion log
X
X
X
X
X
X
TTE
X(2)
X(2)
Esophageal 
visualization
X
X
MRI or CT for PVS
X(3, 
11)
X(3)
NIHSS (performed by 
neurologist)
X(1)
X(1)
X(1)
X(1)
X(1)
X(1)
MMSE (performed by 
neurologist)
X 
X(1)
X(1)
X(1 )
X(1 )
X(1)
X(1)
mRS (performed by 
neurologist)
X(1)
X(1)
X(1)
X(1)
X(1)
X(1)
INR
X
X
X
X
X
X
X
X
X
X
X
X
ACT
X
X
48 hour ambulatory 
ECG monitoring
X(11)
X
TEE
X(5)
X(5)
AE review
X
X
X
X
X
X
X
X
X
X
X
GENius Data File 
Collection
X
X

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neurological signs/symptoms consistent with stroke) at the time the deficit or symptoms 
present and all subsequent study follow up visits.
Concomitant Medications: All prescribed cardiovascular and vitamin K antagonist
medications and dosages will be collected at protocol defined study visits and 
unscheduled study visits.
For purposes of the study, cardiovascular medications are defined as the following
major types of cardiovascular medications per American Heart Association (AHA):

Anticoagulants

Antiplatelet agents

Angiotensin-converting enzyme (ACE) inhibitors

Angiotensin-II receptor blockers (or inhibitors), also known as ARBs

Antiarrhythmic drugs (AADs)

Beta blockers

Calcium channel blockers

Diuretics

Vasodilators

Digitalis preparations

Statins
Therapeutic anticoagulation: Therapeutic anticoagulation is defined as an INR of 2.0
to 3.5. All subjects are required to be prescribed to a vitamin K antagonist (VKA) 30 
days prior to the ablation procedure to achieve therapeutic anticoagulation.  Subjects will 
then be required to stay on a VKA for the remainder of their study participation.
Antiarrhythmic Drug (Class I and III) and Direct Cardioversion Use: All subjects will 
be allowed to be prescribed to one or more class I and/or III antiarrhythmic drug and 
undergo direct cardioversion as described in Table 8 below.
Table 8: Class I and III Antiarrhythmic Drug Use Intervals
AAD & DC 
Cardioversion
Use Intervals
Amiodarone
Allowed; Baseline to 
3 month visit
Not allowed within 90 days 
prior to 6-month Holter *
Class I and III AADs
Allowed; Baseline –
4 months
Not allowed within 60 days 
prior to 6-month Holter*
DC cardioversions
Allowed; Baseline –
4 months
Not allowed within 60 days 
prior to 6-month Holter*
*For patient safety and welfare, investigators are allowed to prescribe the use of AAD or 
DC Cardioversions if medically necessary during “not allowed” use intervals. However, 
this will be considered a protocol deviation.

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History of Atrial Fibrillation: At the time of enrollment, the investigators are required to
indicate in the subjects’ medical record whether the existing atrial fibrillation is persistent 
or long-standing persistent as defined in the inclusion criteria. In addition, the subject will 
be required to complete a 48-hour ambulatory ECG monitor at the baseline visit to 
demonstrate persistent AF at the time of enrollment.
Arrhythmic symptom review: Subjects will be queried to determine what symptoms if 
any, they are experiencing due to atrial fibrillation at protocol defined clinic visits and 
unscheduled clinic visits. 
12 Lead ECG: Will be collected at protocol defined study visits and unscheduled study 
visits to determine heart rhythm along with specific intervals.  The Baseline 12 lead ECG 
should be completed within the 3 months prior to the index ablation procedure.
Cardioversion Log: At protocol defined study visits and unscheduled study visits the 
cardioversion log will be updated with the date of any electrical cardioversions that have 
been performed since last clinic visit.
48-hour ambulatory ECG monitor: Will be collected at protocol defined study visits to 
determine heart rhythm.  Examples of ambulatory ECG monitors are Holter monitors, 
wearable wireless adhesive ECG monitors (e.g. ECG patch monitors). 
For the Baseline ambulatory ECG monitoring, this should be completed within the 3 
months prior to the index ablation procedure to document study subject has continuous 
AF.  Subjects may be asked to repeat an ambulatory ECG monitoring session if less 
than 24 hours of analyzable monitoring time is obtained or continuous AF is not 
demonstrated.  The ambulatory ECG monitoring technology used at the 6-month visit 
should be the same as the technology used at the baseline visit.
Trans-thoracic echocardiogram (TTE): Will be collected at Baseline or within previous 
6 months of the index or reablation procedure to determine atrial volume and size.
Trans-esophageal echocardiogram (TEE): Will be collected within 48 hours prior to 
the index or reablation procedure to rule-out left atrial thrombus.
If a left atrial thrombus is visualized during pre-procedure TEE, the study subject will not 
undergo the study ablation procedure at that time.
MRI/CT scan (Chest): Will be done prior to ablation procedure and 3 months post index 
ablation procedure for the assessment of PVS in subjects in the PVS assessment 
cohort.
For the Baseline scan, this should be completed within the 3 months prior to the index 
ablation procedure.

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
Continue ACT measurements every 20-30 minutes thereafter until all Phased RF 
catheters are removed from body
7.9.3
PVAC or PVAC GOLD catheter introduction

Pause continuous drip/flush of left atrial sheath

Aspirate and flush the left atrial sheath prior to introduction of the catheter

Follow catheter introduction and use instructions described in the instructions for use

Capture the spiral array in the capture device while submerged in a saline and/or 
heparinized saline bath

Aspirate and flush left atrial sheath once catheter array is beyond the sheath valve to
exclude air ingress.

Resume continuous drip/flush of left atrial sheath
7.9.4
PVAC or PVAC GOLD pulmonary vein ablation 

Follow instructions described in the catheter instructions for use and generator operator 
manual

Map for pulmonary vein potentials

Initiate ablation in 4:1, 2:1, or 1:1 mode only

Verify isolation of the pulmonary veins after 30 minutes
7.9.5
MASC catheter introduction

Pause continuous drip/flush of left atrial sheath

Aspirate and flush the left atrial sheath prior to introduction of the catheter

Follow catheter introduction and use instructions described in the instructions for use

Capture the array in the capture device while submerged in a saline and/or heparinized 
saline bath

Aspirate and flush left atrial sheath once catheter array is beyond the sheath valve to 
exclude air ingress.

Resume continuous drip/flush of left atrial sheath 
7.9.6
MASC septal ablation 

Follow catheter introduction and use instructions described in the instructions for use

Map for arrhythmogenic tissue

Initiate ablation in 1:1 ablation mode only

Verify elimination of arrhythmogenic tissue
7.9.7
MAAC catheter introduction

Pause continuous drip/flush of left atrial sheath

Aspirate and flush the left atrial sheath prior to introduction of the catheter

Follow catheter introduction and use instructions described in the instructions for use

Capture the array in the capture device while submerged in a saline and/or heparinized 
saline bath

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7.13 6 month follow-up

Physical Exam

Neurologic evaluation and assessments for subjects previously diagnosed with a
focal or global neurological deficit and/or signs/symptoms suggestive of stroke;  
assessments include:

NIHSS

MMSE

mRS

12 lead ECG

48 hour ambulatory ECG monitor.  Note: the same ambulatory ECG monitoring 
technology used at the Baseline visit should be used at the 6-month follow-up visit.  
Subjects may be asked to repeat an ambulatory ECG monitoring session if less 
than 24 hours of analyzable monitoring time is obtained.

Review of arrhythmic symptoms

INR 

Concomitant medications

Cardioversion history
7.14 Unscheduled follow-up visits
An unscheduled visit is defined as any unplanned office visit at the study site that occurs 
between protocol required visits. The requirements at an unscheduled visit are:

Physical Exam

Neurologic evaluation
o
If evaluation identifies focal or global neurological deficit and/or signs/symptoms  
suggestive of stroke; then the following assessments are required:

NIHSS

MMSE

mRS

12 lead ECG

Review of arrhythmic symptoms

INR  

Concomitant medications

Cardioversion history

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7.15 Permissible Retreatment Ablation Procedure
All study subjects may have one reablation procedure with the Phased RF System within 
180 days of their index ablation procedure under this protocol if the following criteria are 
met:

Subject has not completed the 6-month follow-up visit

Recurrent AF/AFL that cannot be controlled with antiarrhythmic drugs and/or 
cardioversion

The subject has not had any other ablation procedure in the left atrium since first 
Phased RF ablation

Subjects undergoing a retreatment procedure are willing to be followed for 6-
months following their retreatment procedure, or until official study closure defined 
as when Medtronic and/or regulatory requirements have been satisfied per the 
Clinical Investigational Plan, whichever occurs first. Medtronic will provide a new 
set of target visit dates following notification of a retreatment procedure as 
described in section 7.6.
7.16 Study Exit
All study subjects should complete the 6-month visit or official study closure, whichever 
comes first. Subjects may be exited from the study for any of the following situations:

Subject has completed 6-month follow-up

Medtronic and/or regulatory requirements have been satisfied per the Clinical 
Investigational Plan

Subject lost to follow-up

Subject death

Subject did not meet inclusion/exclusion criteria

Subject did not provide consent or data protection authorization

Subject chooses to withdraw (e.g., consent withdrawal, relocation to another 
geographic location) 

Investigator deems withdrawal necessary (e.g., medically justified, 
inclusion/exclusion criteria not met, failure of subject to maintain adequate study 
compliance)

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7.16.1 Lost to follow-up
In the case that the subject is determined to be lost to follow-up, details of a minimum 
of two attempts and the method of attempt (e.g., one letter and one phone record or 
two letters) to contact the subject must be recorded. In addition, follow the regulations 
set forth by the governing IRB/MEC. The study design accounts for possible lost to 
follow up and therefore those subjects will not be replaced.
7.16.2 Subject-initiated withdrawal
If subject chooses to withdraw, document reason for exit.
7.16.3 Early study suspension or termination
Medtronic may decide to suspend or prematurely terminate the study (e.g. if 
information becomes available that the risk to study subject is higher than initially 
indicated or because of other reasons). If the study is terminated prematurely or 
suspended, Medtronic shall promptly inform the clinical investigators of the termination 
or suspension and the reason(s) for this. The investigator shall then promptly inform the 
reviewing IRB/MEC and the study subjects or their legal representative. Subjects will 
be followed per clinical standard of care.
7.16.4 Early investigation site suspension or termination
Medtronic may decide to suspend or prematurely terminate an investigation site (e.g. in 
case of expiring approval of the reviewing MEC, non-compliance to the Clinical 
Investigation Plan or lack of enrollment). If an investigation site is suspended or 
prematurely terminated, Medtronic shall promptly inform the clinical investigator(s) of 
the termination or suspension and the reason(s) for this. The investigator shall then 
promptly inform the reviewing IRB/MEC and the study subjects or their legal 
representative. Subjects will be followed per clinical standard of care.
7.17 Study Closure
Study Closure is a process initiated by distribution of an initial study closure letter. 
Study closure is defined as closure of a clinical study that occurs when Medtronic 
and/or regulatory requirements have been satisfied per the Clinical Investigational Plan 
and/or by a decision by Medtronic or regulatory authority, whichever occurs first. The 
study closure process is complete upon distribution of the Final Report or after final 
payments, whichever occurs last. Ongoing IRB and/or EC oversight is required until the 
overall study closure process is complete.
7.18 Concomitant Medications
All cardiovascular and vitamin K antagonist medications (as specified in Section 7.7 
Study procedure details – Concomitant Medications) that subjects are prescribed at the 
time of the baseline visit will be documented on the concomitant medication log. At 
protocol defined study visits and any unscheduled visits; the concomitant medication 
log will be updated to reflect any changes in the subject’s medications.

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8.
INVESTIGATIONAL DEVICE/SOFTWARE STORAGE,
HANDLING AND TRACEABILITY
The Phased RF System is considered investigational in U.S. (GENius generator and 
components, PVAC or PVAC GOLD, MASC and MAAC) and Canada (MASC and MAAC only). 
In Europe, the Phased RF system is market released. In regions where the system is market 
released, the system will be used in the manner for which it was intended and it will not be 
considered as investigational.
U.S. and Canada
Investigational product will be distributed to a center only when Medtronic has received all 
required documentation and has notified the center of center activation. Distribution of the 
investigational product to study centers during the clinical study will be managed by Medtronic 
and can only be ordered by Medtronic personnel. Investigational product must be stored in a 
secure location at the site. It is the responsibility of the investigator to correctly handle, store, 
and track the investigational products.  Investigational products will be used only in the study 
according to the CIP. 
Europe
For geographies in which the product is market released, distribution of the product will be 
done by standard distribution methods.
All Geographies
Product Distribution logs will be automatically generated by the electronic data management 
system for tracking of all Phased RF products. The Product Distribution Logs are to be used 
for the Phased RF System GENius generator, PVAC or PVAC GOLD, MASC and MAAC 
catheters, GENius JR remote and ECG interface box. The logs must be maintained at each 
investigational center and updated when investigational product is received (U.S. and Canada 
only), opened, disposed of or returned to Medtronic
8.1
Final product disposition
All product should be returned to Medtronic for analysis when permissible by local laws 
and regulations. If the products are not returned, a justification is required to be reported 
on the appropriate case report form(s) or disposition log(s). The Product Distribution Log
must be updated for all Phased RF products. To receive a Returned Product Mailer Kit, 
please contact your local Medtronic field personnel. All unused investigational product
(U.S. and Canada Only) must be returned to Medtronic upon study closure at the center. 
The Product Disposition Log must be updated with the final device disposition.
Study sites in all geographies should return opened/used study devices as instructed by 
Medtronic.

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9.
STUDY DEVIATIONS
A study deviation is defined as an event within a study that did not occur according to the 
Clinical Investigation Plan or the Clinical Trial Agreement.
Prior approval by Medtronic is expected in situations where the investigator anticipates, 
contemplates, or makes a conscious decision to deviate. Prior approval is not required when a 
deviation is necessary to protect the safety, rights or well-being of a subject in an emergency 
or in unforeseen situations beyond the investigator’s control (e.g. subject failure to attend 
scheduled follow-up visits, inadvertent loss of data due to computer malfunction, inability to 
perform required procedures due to subject illness).
For medically justifiable conditions which preempt a subject’s ability to complete a study-
required procedure, it may be permitted to report only one deviation which will apply to all visits 
going forward. This may also apply for other unforeseen situations (e.g. the subject 
permanently refuses to complete a study required procedure. However, prior approval from 
Medtronic is required for such situations. (Examples may include: unable to complete MRI due 
to claustrophobia). 
All study deviations must be reported on the Case Report Form regardless of whether 
medically justifiable, pre-approved by Medtronic, an inadvertent occurrence, or taken to protect
the subject in an emergency. 
In the event the deviation involves a failure to obtain a subject’s consent, or is made to protect 
the life or physical well-being of a subject in an emergency, the deviation must be reported to 
the Institutional Review Board (IRB) as well as Medtronic within five (5) working days.  
Reporting of all other study deviations should comply with MEC/IRB policies and/or local laws 
and must be reported to Medtronic as soon as possible upon the center becoming aware of the 
deviation. Reporting of deviations must comply with IRB/ MEC policies, local laws, and/or 
regulatory agency requirements.  Refer to Investigator Reports, Table 15, Table 16, Table 17
and Table 18, for geography-specific deviation reporting requirements and timeframes for 
reporting to Medtronic and/or regulatory bodies.  
Medtronic is responsible for analyzing deviations, assessing their significance, and identifying
any additional corrective and/or preventive actions (e.g. amend the Clinical Investigation Plan, 
conduct additional training, terminate the investigation). Repetitive or serious investigator 
compliance issues may result in initiation of a corrective action plan with the investigator and 
site, and in some cases, necessitate suspending enrollment until the problem is resolved or 
ultimately terminating the investigator's participation in the study. Medtronic will provide center-
specific reports to investigators summarizing information on deviations that occurred at the 
investigational site on a periodic basis.
Examples of study deviations include but are not limited to the following:
IRB/MEC approval not obtained before starting the study
IRB/MEC approval lapse during the study
Subject enrolled during lapse of IRB/MEC approval
Informed consent not obtained prior to participation in the study
Incorrect version of the consent form provided to the subject

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Control of investigational product not maintained or inadequate
Unauthorized use of an investigational product outside of the study
Adverse event not reported by investigator in the required regulatory time frame
Enrolled subject did not meet inclusion/exclusion criteria
Visit outside of the protocol defined window
Visit not completed
Protocol-required testing or programming not done
Source data permanently missing (i.e., hospital/clinic records)
Unauthorized physician or study personnel performing study procedures
10. ADVERSE EVENTS AND DEVICE DEFICIENCIES
Timely, accurate, and complete reporting and analysis of safety information for clinical 
studies is crucial for the protection of subjects, investigators, and the sponsor. Reporting 
and analysis of safety data is mandated by regulatory authorities worldwide. Medtronic
(sponsor) has established Standard Operating Procedures (SOPs) in conformity with 
worldwide regulatory requirements to ensure appropriate reporting of safety information. 
This study is conducted in accordance with these SOPs and regulations.
Since the safety reporting requirements and classification systems vary for each regulatory 
agency and per applicable regulation, requirements from all geographies are taken into
account for the collection and reporting of safety information.
There are no adverse event (AE) stopping rules tied to the collection and reporting of AEs for 
this study, except for those rules identified in the regulatory requirements. However, if more 
than six (6) strokes that meet the definition of the primary safety endpoint as described in 
Table 5 occur prior to completing enrollment, the study may stop early for futility.
For any changes in status of a previously reported AE (i.e. change in action, change in 
outcome, change in relatedness, change in seriousness), an AE update must be completed.
All AEs must be followed until resolved, ongoing without further actions to be taken, the
subject exits the study or until study closure, whichever occurs first. In the event that a 
subject is exited from the study prior to study closure, all efforts should be made to continue 
following the subject until all ongoing AEs are resolved or they are ongoing without further 
actions to be taken.

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Foreseeable Adverse Events
The Phased RF system used within the VICTORY AF study is currently market released in
Europe. Foreseeable adverse event information associated with the Phased RF System is 
provided in the Phased RF catheter device labeling that is included with each ablation 
catheter. Additionally, information related to recent clinical experience can be found in the 
report of prior investigations.
10.2 Adverse Event and Device Deficiency Definitions, Classification and
Reporting
Adverse Event Classification and Reporting
AEs will be classified according to the classifications and definitions provided. In 
order to meet the requirements of the regulatory agencies (RA), each event will be 
classified by the investigator according to the standard regulatory definitions as 
outlined in Table 10. Where the definition in Table 10 (with the exception of the 
system relatedness section) indicates “device”, it refers to any device used in the 
study. This might be the device, or any market released component of the system.
AE reporting must be completed according to local regulatory requirements as well as 
per reporting detailed in Tables 12 and 13, as applicable.
It is the responsibility of the investigator to abide by the adverse event reporting 
requirements stipulated by the site’s Investigational Review Board (IRB)/ Medical 
Ethics Committee (MEC)
Upon sponsor receipt of AEs, a sponsor study team member will review the AE for 
completeness and accuracy and when necessary will request clarification and/or 
additional information from the investigator. Sponsor will utilize the Medical Dictionary 
for Regulatory Activities (MedDRA) to assign a MedDRA term for each AE based on 
the information provided by the investigator.
For emergency contact regarding AEs, contact a Medtronic Clinical Research 
Specialist immediately. Study contact information is provided in the CIP as well as in 
the center’s study documents binder/investigator site file and will be updated if 
contact information changes.
Vigilance activities will be conducted in parallel and, if possible, in conjunction with the 
CEC activities to ensure adherence to the required reporting timelines.
Reporting of Device Deficiencies
Device deficiencies that did not lead to an AE but could have led to a serious adverse 
device effect (SADE)

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Subject Death
All subject deaths must be reported by the investigator to the sponsor as soon as 
possible after the investigator first learns of the death. Report the Adverse Event, 
documenting the event resulting in the subject’s death.
A copy of the death certificate, if available and allowed by state/local law, should 
be sent to the sponsor clinical study team. When a death occurs in a hospital, a 
copy of the physician’s dictated death summary report and all relevant hospital 
records should be sent to the sponsor clinical study team, if available. If an 
autopsy is conducted, the autopsy report should also be sent to the sponsor 
clinical study team. When the death occurs at a remote site, it is the investigative 
center’s responsibility to attempt retrieval of information about the death. In 
summary, the following data will be collected:

Date of death

Detailed description of death

Cause of death

Relatedness

Death certificate (if available and/or allowed by state/local law)

Death summary/hospital records (if available and allowed by state/local 
law)

Autopsy report (if available and allowed by state/local law)
Death Classification and Reporting
Sufficient information will be required in order to properly classify the subject’s 
death. The investigator shall classify each subject death per the definitions 
provided in Table 12.

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The CEC will consist of a minimum of three (3) non-sponsor employed physicians
(including one vascular neurologist and one electrophysiologist), and the CEC chairperson. 
The CEC members will not include participating VICTORY AF investigators. The purpose 
of the CEC is to conduct a medical review of events for subjects participating in the study. 
At least three CEC members must adjudicate, at a minimum, all deaths, all neurologic 
events, and all AEs related to any component of the system. All other AEs will be 
adjudicated by at least one physician member of the CEC.
Sponsor personnel may facilitate and participate in CEC meetings but will be non-voting
members. The sponsor will provide the CEC with the investigator’s description and 
classification of each AE in addition to sponsor’s assignment of the MedDRA key term.
Additionally, the sponsor’s assignment of the complication or observation classification will 
be provided for all system and procedure related AEs. The CEC is responsible for reviewing 
the investigator’s assessment and classification of each event. The CEC will review adverse 
events and provide a final adjudication of relatedness and seriousness as applicable for all 
events as well as the complication/observation classification for system or procedure related 
events. In addition, the CEC will determine the cardiovascular and neurological relatedness 
of each AE. If the CEC disagrees with the investigator’s classification of the event, the 
rationale will be provided to the investigator. If the investigator agrees with the CEC, this will 
be documented accordingly. If the investigator does not agree with the CEC classification, 
both determinations will be documented within the study report. However, the CEC
determination will be used for analysis purposes.
Additionally, the CEC will determine whether each AE meets the definition of a procedure 
and/or device related stroke in Table 5 or the TIA definition in Table 10.
10.4 Steering Committee (SC)
The steering committee will be an advisory body to the VICTORY AF study team and be 
responsible for collaboration and guidance on study goals, design, study center 
communications, training materials and other activities based on expertise or as agreed upon.
The study’s steering committee (SC) will be comprised of non-Medtronic physicians including 
at least one EP and one neurologist.  
10.5 Data Monitoring Committee (DMC)
Ongoing oversight for this study will be provided by an independent DMC. The DMC will 
consist of a minimum of at least one electrophysiologist, one neurologist, and one statistician
who are not sponsor employees.  The DMC will not include participating VICTORY AF 
investigators, members of the Steering Committee or Clinical Events Committee.
The DMC is retained to aid the sponsor in safeguarding the interests of trial participants and 
monitoring the overall conduct of the study. The DMC will meet at regular intervals or as 

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agreed upon to review accumulating study data and will be advisory to the sponsor and may
provide recommendations for early termination of the trial. Review and consensus by the 
entire committee is required to recommend that the study should be stopped. The DMC may 
also make recommendations related to the selection, management and retention of subjects, 
improvement of adherence to protocol-specified regimens, and procedures for data 
management and quality control.
10.6 Market Released Event Reporting
The following definitions apply to all market released products used in the clinical study 
and must be reported according to standard market release reporting guidelines per 
geography.
Medical Device Reporting (MDR) Requirements for User Facilities (U.S.)
General Reminder for Investigators:
Per FDA regulations, Device User Facilities are required to report Medical Device
Reports (MDR) on market approved products (21 CFR 803, subpart C) A Device User 
Facility is defined as a hospital, an ambulatory surgical facility, a nursing home, an 
outpatient treatment facility, or an outpatient diagnostic facility which is not a physician’s 
office.
Vigilance Reporting (EEA)
It is the responsibility of the investigator to report all product complaints and misuse 
and abuse immediately via the regular channels for CE marked products. The 
reporting of product complaints abuse, and misuse of these CE-labeled devices is not 
part of the clinical study and should be done in addition to the AE reporting 
requirements.
10.7 Investigator Adverse Event and Device Deficiency Recording and Reporting
Requirements
AEs and device deficiencies will be recorded and reported according to local 
regulatory requirements. Refer to Table 13 AE requirements.  It is the responsibility of 
the Investigator to abide by the adverse event reporting requirements stipulated by 
the centers’ IRB/MEC.

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In Europe, Phased RF ablation catheters are approved to treat subjects with persistent 
atrial fibrillation. If successful, the VICTORY AF study could confirm meaningful 
therapeutic benefit in this underserved population.
12. STATISTICAL METHODS AND DATA ANALYSIS
Medtronic employees or their designated representatives will perform all statistical 
analysis.
Additionally, a separate Statistical Analysis Plan (SAP) will be developed to further 
describe statistical methods, pre-specified data handling rules, and pre-specified 
analyses that will be included in study reports (e.g. PMA report, final study report). 
Additional exploratory analyses of the data may be conducted as deemed appropriate.
The study will be considered successful if the primary objective is met.  Specifically, for 
the study to be successful, the observed procedure and/or device related stroke rate 
must be less than 1.8% and its associated exact one-sided upper 95% confidence 
interval must be less than 3.5%.  
12.1 General Summaries
12.1.1 Description of Baseline Variables
Standard baseline and relevant medical history will be collected on the CRFs 
for all enrolled subjects.  Baseline variables to be summarized include, but are 
not limited to:  age, sex, race, physical exam findings, arrhythmia history, 
arrhythmic symptoms, baseline ECG interpretation, AF medication history, 
baseline MMSE score, baseline CHADS2 score and CHA2DS2-VASc.
For continuous variables, mean standard deviation, median, and range will be 
reported.  For categorical variables, frequency and percentage will be reported.  
Summaries of baseline information and relevant medical history will be 
summarized for all enrolled subjects, all subjects with a Phased RF ablation 
procedure (e.g. at least one Phased RF catheter placed in the left atrium), 
subjects randomized to the PVS assessment cohort
 
12.1.2 Summary of Ablation Procedures
A summary of Phased RF ablation procedure information including procedure 
times, ablation locations, Phased RF ablation catheters used, and ablation 
energy modes will be summarized for procedures where at least one Phased 
RF ablation catheter was placed in the left atrium.  
12.1.3 PVAC and PVAC GOLD catheter use
If Phased RF ablation procedures are performed with more than one PVAC 
model, subgroup analyses will be performed on the primary and secondary 

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objectives 
 by PVAC model.  Specifically, 
should the need for a subgroup analysis occur, three subgroups will be defined 
as subjects ablated with only the PVAC catheter (index and reablation 
procedure), subjects ablated with only the PVAC GOLD catheter (index and 
reablation procedure), and subjects ablated with both the PVAC and PVAC 
GOLD catheter (e.g. index procedure with PVAC catheter and reablation
procedure with PVAC GOLD catheter).  For each of these objectives, Fisher’s 
Exact test would then be used to assess the heterogeneity of the results by 
PVAC catheter subgroup should the need for a subgroup analysis arise.
12.2 Primary Objective: 30-day procedure and/or device related stroke rate
12.2.1 Objective
Demonstrate that the observed incidence of procedure and/or device related
incidence of new stroke (excludes transient ischemic attack) within 30 days of 
an ablation procedure (index or reablation) with the Phased RF System is less 
than 1.8% with observed upper confidence boundary that is less than 3.5%.
12.2.2 Hypothesis
To pass the primary objective the following two conditions must be met:
1. The observed procedure and/or device related stroke rate must be less 
than 1.8%.
2. The exact one-sided upper 95% confidence interval for the procedure 
and/or device related stroke rate must be less than 3.5%.
The formal statistical hypothesis for the primary objective is:
Ho: ≥ 3.5%
Ha: < 3.5%
where is the true 30-day post ablation procedure (index or reablation) 
procedure and/or device related stroke rate.
12.2.3 Definition of procedure and/or device related stroke
Procedure and/or device related strokes are defined as events classified by the 
CEC meeting all of the requirements in Table 5.  Specifically, the stroke must 
have a symptom onset date within 30 days of an ablation procedure where at 
least one phased RF catheter is deployed into the left atrium and be considered 
related to the procedure and/or device by the CEC.
12.2.4 Rationale for stroke threshold
The peri-procedural stroke rate is not well characterized in the persistent and 
long-standing persistent AF population.  The observed procedure or device 
related stroke rate among the 176 ablated subjects in the TTOP-AF study was 

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2.8% with an upper one-sided 95% confidence interval of 5.9%.  However, the 
FDA Center for Devices and Radiological Health’s cardiac devices advisory 
panel indicated that both the observed stroke rate and its associated upper 
confidence boundary in the TTOP-AF study were too high to enable approval of 
the phased RF ablation system.  Medtronic has identified several mitigation 
strategies that are expected to lower the peri-procedural stroke rate.  With 
these mitigation strategies enforced in the current protocol, Medtronic believes
the true procedure and/or device related peri-procedural stroke rate will be less 
than 1.8%, a value similar to the peri-procedural stroke rates reported in recent 
observational studies.
Specifically, a single site registry study by Patel et al., reported a 1.8% per-
procedural stroke rate (one-sided upper 95% CI: 2.6%) among 1209 subjects 
with persistent or long-standing persistent AF undergoing off label AF ablation.  
Additionally, Patel et al. found that persistent AF was the only independent 
predictor of peri-procedural stroke risk in a multivariable analysis.  A similar 
study was performed by Spragg et al, evaluating 517 subjects with atrial 
fibrillation. The stroke rate was 1.7% (95% one-sided UCB; 3.8%) for the 240 
subjects with persistent atrial fibrillation.  A key limitation with these
observational trials is that the studies’ did not require rigorous follow-up 
protocols and therefore the stroke rates may be under reported.    
After considering all available data sources together with close consultation 
with the FDA, a procedure and/or device related peri-procedural stroke 
threshold of 3.5% was chosen.  This threshold is greater than the upper one-
sided 95% confidence intervals reported by Spragg et al and Patel et al but is 
lower than the upper confidence interval for the peri-procedural stroke rate 
observed in the TTOP-AF study.  Additionally, a peri-procedural stroke 
threshold of 3.5% mandates that the observed study stroke rate must be less 
than 1.8% for study success for a sample size of at least 300 ablated subjects.
12.2.5 Experimental design and analysis methods
This study is a prospective, unblinded, multi-center, worldwide clinical study 
designed to evaluate the procedure and/or device related peri-procedural stroke 
rate within 30 days of an ablation procedure with the Phased RF System.  The 
study will be considered successful if the primary objective is met. A single 
decision regarding study success will be made once all subjects with a Phased RF
ablation procedure have had the opportunity for a reablation procedure (completed 
the 6-month visit) or completed the 30-day post-reablation visit if a reablation is 
required.  Alternatively, the study may stop early for futility if more than six (6) 
procedure and/or device related peri-procedural strokes occur prior to completing 
enrollment.
For computing the peri-procedural stroke rate, the denominator will be all subjects 
with at least one ablation procedure attempt where at least one of the Phased RF
catheters was deployed into the left atrium and have at least 30 days of post-

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procedure follow-up. Also, subjects who have a procedure and/or device related 
peri-procedural stroke as classified by the CEC with symptom onset date within 30 
days of a Phased RF ablation procedure will be included.  The numerator for the 
stroke rate will be all subjects included in the denominator that had a procedure 
and/or device related stroke as classified by the CEC with a symptom onset date 
within 30 days of a Phased RF ablation procedure.   The null hypothesis will be 
rejected in favor of the alternative if the observed stroke rate is less than 1.8% and 
the exact one-sided upper 95% confidence interval is less than 3.5%.  
Additionally, a one-sided exact p-value will be computed for comparing the 
observed stroke rate to the performance goal of 3.5%.
12.2.6 Sample size and power
A sample size of 300 subjects completing the 30-day post procedure follow-up 
visit and having the opportunity for a reablation procedure (i.e. completing the 6-
month follow-up visit) or having a reablation procedure and completing the 30-day 
post-reablation visit provides at least 80% power to test the primary study 
hypothesis given the following assumptions:
1. One-sided type I error rate of 0.05
2. Exact test of a binomial proportion versus a fixed performance goal of 
3.5%
3. Observed stroke rate must be less than 1.8%.
4. Assumed true stroke rate is 1.3%
Figure 1 displays the power of the study to meet its primary objective when the 
true stroke rate ranges from 0.1% to 3.5% and 300 subjects complete the 30-day 
post-ablation (or reablation) visit and have had the opportunity for a reablation 
procedure.  Specifically, the study has 90% power if the true stroke rate is 1%, 
80% power if the true stroke rate is 1.3%, and 55% power if the true stroke rate is 
1.8%.  Figure 1 also demonstrates that the type I error is less than 5% when the 
true stroke rate is 3.5%.  
Assuming an annualized attrition rate of 10% following the index ablation 
procedure, a uniform reablation rate of 30% within 180 days of the index ablation 
procedure, and a conservative 26% pre-procedure attrition rate up to 420enrolled 
subjects will be required to ensure that at least 300 subjects complete the 30-day 
post ablation follow-up visit and have the opportunity for a reablation procedure or 
have a reablation procedure and complete the 30-day post-reablation procedure 
visit.  Note that it is not anticipated that all 420 subject enrollments will be required, 
since study enrollment will cease once enough subjects have completed an index 
Phased RF procedure to ensure that the target sample size of 300 evaluable 
subjects can be obtained.  

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Figure 1: Study Power versus True Stroke Rate
0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
20
40
60
80
100
True Stroke Rate (%)
Study Power (%)
12.2.7 Determination of subjects for analysis
All subjects with at least one attempted ablation procedure with the Phased RF 
system where at least one investigational catheter was deployed into the left atrium
and have completed at least 30 days of post-procedure follow-up will be included in 
the analysis.  Additionally, all subjects with a procedure and/or device related stroke 
as classified by the CEC with a symptom onset date within 30 days of a procedure
where a Phased RF catheter was placed in the left atrium will be included in the 
analysis regardless of whether the subject has less than 30 days of post-procedural 
follow-up.
In the rare instance where a subject has a non-investigational ablation catheter 
placed in the left atrium, the subject will be excluded from the analysis of the 
primary objective.  However, a summary of all peri-procedural AEs will be provided 
for any subject excluded from the primary analysis.
12.2.8 Missing data
The impact of missing data on the analysis of this objective is expected to be small 
since only a 30 day post-ablation follow-up period is required.  However, missing 
data could arise if a subject undergoes a Phased RF ablation procedure, does not 
have procedure and/or device related peri-procedural stroke, and exits the study 

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prior to their 30 day post-procedure visit.  These subjects will not be included in the 
primary analysis cohort, but a tipping point analysis will be employed to determine 
the impact of the missing data on the observed stroke rate should the issue of 
missing data arise.
Another potential source of missing data comes from subjects that do not have a 
stroke following the index procedure, but exit the study following the 30-day post-
index ablation visit, but prior to the 6-month visit or a reablation procedure.  These 
subjects are included in the primary analysis as not having a stroke since no stroke 
was observed following the index ablation procedure.  However, a tipping point 
analysis will be conducted to determine the plausibility these subjects could 
change the outcome of the study across a range of reablation rates and reablation 
stroke rates.  
12.2.9 Pre-specified Subgroup analyses
The procedure and/or device related stroke rate will be displayed separately by 
gender (male/female), AF type (persistent/long-standing persistent), age (≤70 years, 
>70 years), and region (US/non-US).  Due to the small number of expected peri-
procedural strokes, the study is not powered for these subgroup analyses, however, 
for these analyses, point estimates and exact one-sided 95% upper confidence 
intervals will be computed within each subgroup.  
12.2.10
Analysis Timing
A visit cutoff date will be defined as the maximum of the last 6-month post-index 
ablation visit, last study exit, or last 30-day post-reablation procedure visit.  The 
data from all visits and procedures meeting this visit cutoff date will be included in 
the analysis.
12.3 Secondary Objectives
12.3.1 Secondary Objective #1:  6-month Post-Procedural Effectiveness
12.3.1.1
Objective
Confirm the 6-month post-procedural effectiveness.  

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12.3.1.2
Hypothesis
There is no pre-specified hypothesis associated with this secondary objective.
Since the 6-month effectiveness of the Phased RF system was shown to be 
superior to optimal medical management in the TTOP-AF study and the primary 
purpose of this study is to evaluate the safety of the system there is no formal 
statistical hypothesis required for this objective.  Thus, the main purpose for 
characterizing 6-month effectiveness is to demonstrate that study investigators are 
not overly cautious during the Phased RF procedure to optimize procedure safety.
12.3.1.3
Definition of 6 Month effectiveness
6-Month effectiveness will be defined as:

Acute procedural success, AND

> 90% reduction in clinically significant AF/AFL by 48-hour ambulatory ECG 
monitor. Clinically significant AF/AFL is defined as; any AF/AFL episode 
lasting longer than 10 consecutive minutes in duration, AND

Off amiodarone for at least 90 days and off all other class I and class III 
antiarrhythmic drugs for at least 60 days prior to the 6-month ambulatory 
ECG monitor, AND

Free from DC cardioversion for AF for at least 60 days prior to the 6-month 
ambulatory ECG monitor
12.3.1.4
Analysis Methods
Acute effectiveness for each subject will be determined as described in section
12.3.2.  In order for a subject to meet the acute procedural success criterion for the 
6-month effectiveness endpoint, the subject must be an acute procedural success 
for their index and reablation procedure (if required).  Ambulatory ECG monitor 
recordings will be completed at the baseline and 6-month post final Phased RF 
ablation visit.  Ambulatory ECG recordings will be read and summarized by the 
Holter core laboratory.  For the baseline and 6-month post-ablation procedure 
ambulatory ECG recording, the percentage of time in clinically significant AF (AF > 
10 minutes) will be calculated as the total number of seconds in clinically significant 
AF divided by the total analyzable ambulatory ECG monitor recording time in 
seconds. The percent reduction from baseline will be calculated as the difference 
of the percentage of time in clinically significant AF between the baseline and 6-
month post-ablation procedure visit divided by the percentage of clinically 
significant AF at baseline.  Subjects with at least a 90% reduction in clinically 
significant AF will be considered successful for the ambulatory ECG component of 
6-month effectiveness endpoint. Adjustments to all cardiovascular medications 
including antiarrhythmic drugs and dates of all DC Cardioversions will be captured 
on the case report forms.  
Only those subjects that have a baseline and 6-month post-procedure 48-hour 
ambulatory ECG monitor data that are readable by the core lab or are missing 
ambulatory ECG data but were 6-month effectiveness failures based on other 
criteria at the time of the visit cutoff date will be included in the analysis of this 

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objective.  Specifically, the denominator for the 6-month effectiveness rate will 
include all subjects that had at least one Phased RF ablation procedure where an 
investigational catheter was deployed into the left atrium and have baseline and 6-
month ambulatory ECG monitor data available or do not have ambulatory ECG 
data available but were 6-month effectiveness failures based on other criteria.  The 
numerator will include all subjects in the denominator that meet all four 6-month 
effectiveness conditions.  A two-sided 95% exact confidence interval for 6-month 
effectiveness rate will be calculated.
12.3.1.5
Determination of subjects for analysis
Only those subjects that have completed both a baseline and 6-month 48 hour 
ambulatory ECG monitor or are 6-month effectiveness failures based on other 
criteria will be included in the main analysis cohort for this objective.
In the event that the recording duration of the ambulatory ECG monitor exceeds 48 
hours (e.g. a 7 day ECG patch monitor is used), the AF burden will be computed by 
the core laboratory for the initial 48 hours only.
Likewise, in the event the ambulatory ECG monitor is less than 48 hours (e.g. due 
to inadequate ECG patch monitor fixation, subject compliance) the AF burden will 
be determined by the core laboratory based on the total usable or analyzable
recording period.  Subjects may be asked to repeat an ambulatory ECG monitoring 
session if less than 24 hours of analyzable monitoring time is obtained. Subjects 
with less than 24 hours of usable ambulatory ECG recording time will be 
considered missing in the analysis (unless they are 6-month effectiveness failures 
based on other criteria) and included in sensitivity analyses as described below.
12.3.1.6
Confidence Interval Width
The 6-month effectiveness rate among all 138 subjects randomized to the ablation 
management arm in TTOP-AF was 55.8% (77/138; 95% CI: 47.1% - 64.2%).  
However, in this intention-to-treat analysis, 17 subjects missing their 6-month 
ambulatory ECG monitor assessment were included in the analysis as failures.  If 
only subjects with 6-month ambulatory ECG monitor data available in TTOP-AF 
were included in the analysis (the analogous analysis cohort in this study) the 6-
month effectiveness rate was 63.6% (77/121; 95% CI: 54.4% - 72.2%).  However, 
the TTOP-AF protocol required amiodarone be discontinued 28 days prior to the 6-
month visit, did not require discontinuation of other antiarrhythmic drugs or DC 
cardioversions until 5 days prior to the 6-month ambulatory ECG monitor 
assessment.  Thus, while it is expected that the estimated 6-month effectiveness 
rate in this study will be greater than 50%, it may be less than 64% due to 
differences in allowed concomitant therapy use between studies.
Based on the following assumptions:

Up to 420 subjects will be enrolled

300 subjects are required to complete the 30-day post-ablation visit and 
have the opportunity for a reablation procedure (i.e. complete 6-month visit) 

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or complete the 30-day post-reablation visit if a reablation procedure is 
required

Total of 55 study centers activated

14 months to activate the 55 centers

Enrollment rate of 0.4 subjects per center per month once activated

30% of subjects will be re-ablated prior to their 6-month visit

10% annualized attrition rate
It was estimated via a simulation study that approximately 284 subjects would 
complete the 6-month ambulatory ECG monitor assessment.  Assuming 200 
subjects have evaluable baseline and 6-month ambulatory ECG monitor data and 
the observed 6-month effectiveness rate is 55%, then the exact 95% two-sided 
confidence interval should have a width no larger than 14.2% with a lower limit of at 
least 47.8%.  Similarly, if the observed 6-month effectiveness rate is 50%, the 
confidence interval width should be no greater than 14.3% with a lower limit of at 
least 42.9%.
12.3.1.7
Missing data
Subjects will only be included in this analysis for the 6-month effectiveness 
objective if they have both a baseline and 6-month 48-hour ambulatory ECG
monitor that are readable by the core lab or are missing a 48-hour ambulatory 
ECG monitor data and 6-month effectiveness failures based on other criteria at the 
time of the visit cutoff date.  However, should the issue of missing data arise; all 
ablated subjects that complete the 6-month visit at the time of the visit cutoff 
regardless of ambulatory ECG monitor data status will be included in a tipping 
point analysis to evaluate the impact of missing data.  Specifically, subjects 
completing the 6-month study visit but missing the ambulatory ECG monitor 
assessment who are not 6-month effectiveness failures based on other criteria will 
be included as successes and then iteratively included as failures in the tipping 
point analysis.
12.3.2 Secondary Objective #2: Acute procedural success
12.3.2.1
Objective
Confirm acute post-procedural effectiveness.  
12.3.2.2
Hypothesis
There is no pre-specified hypothesis associated with this secondary objective.
12.3.2.3
Definition acute procedural success
Acute procedural success is defined as meeting all four of the following conditions:
1. Only Phased RF catheters used in the left atrium to achieve procedure 
success AND
2. All accessible pulmonary veins were isolated (entrance block)
3. CFAEs and high frequency intracardiac electrogram amplitudes were mapped 
and ablated as necessary with Phased RF System

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4. Sinus rhythm is restored at the end of the ablation procedure (with or without 
cardioversion)
12.3.2.4
Analysis Methods
All ablation procedure parameters will be captured on the case report forms.  For 
estimating the acute success rate, all subjects with an attempted ablation where at 
least one of the Phased RF catheters were deployed into the left atrium will be 
included in the denominator.  The numerator will include all subjects in the 
denominator who met all the conditions for acute procedural success defined 
above.  A two-sided lower 95% exact confidence interval for the acute procedural 
success rate will be calculated.  Subjects that have a reablation attempt will be 
considered acutely successful if they meet all the conditions for their index 
procedure and conditions 1 and 4 of the acute success definition for their 
reablation attempt since the source of recurrent AF will be unknown.
In addition to calculating the acute success rate on a per subject basis, the acute 
success rate will be calculated on a per procedure basis.  The denominator for the 
per procedure rate will be all Phased RF procedures where at least one Phased 
RF catheter was deployed into the left atrium.  The numerator will be all Phased 
RF procedures in the denominator that meet all four conditions of the acute 
success definition.  A two-sided 95% two-sided confidence interval for this rate will 
also be calculated using the method of Rao and Scott for clustered binary data 
since subjects may have up to two ablation procedures.
12.3.2.5
Determination of subjects for analysis
All ablation procedures that meet the cutoff date for the analysis of the primary 
objective where at least one Phased RF catheter was deployed into the left atrium 
will be included in the analysis.
12.3.2.6
Missing data
There is not expected to be any missing data associated with the analysis of this 
objective since the objective is evaluated at the time of the procedure.  
12.3.3 Secondary Objective #3:  Pulmonary Vein Stenosis
12.3.3.1
Objective
Characterize the incidence of PVS 3 months post ablation procedure as 
determined by MRI or CT scan.
12.3.3.2
Hypothesis
There is no pre-specified hypothesis associated with this secondary objective.
12.3.3.3
Definition of pulmonary vein stenosis
Pulmonary vein stenosis will be defined as: a greater than 70% reduction in the 
baseline luminal diameter.

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12.3.3.4
Analysis Methods
One hundred (100) subjects will be randomized to the PVS assessment cohort.  
Subjects randomized to the PVS assessment cohort will have a CT-scan or MRI 
scan at their baseline visit and a CT-scan or MRI scan for PVS assessment at their 
first 3-month post-ablation visit (e.g. subjects with a reablation procedure following 
their 3-month post index ablation assessment will not have another scan at their 3-
month post reablation visit). The core laboratory’s assessment of PVS status will 
be collected on the CRFs. For computing the PVS rate at 3 months post ablation 
the denominator will be all subjects that are randomized to the PVS assessment 
cohort, have at least one ablation procedure with one or more Phased RF
catheters deployed, and have evaluable CT or MRI scans available at their 
baseline and 3-month follow up visits.  The numerator will be all subjects included 
in the denominator that were classified by the core laboratory as having PVS by 
the core laboratory.   A two-sided 95% exact confidence interval for the 3-month 
post-procedure PVS rate will be calculated.   
12.3.3.5
Determination of subjects for analysis
Only those subjects that are randomized to the PVS assessment cohort, have at 
least one ablation procedure with one or more Phased RF catheters deployed in 
the left atrium, and have CT or MRI scans at baseline and at the 3-month follow-up 
visit (or 3-month post-reablation visit if subject was reablated) that are readable by 
the core lab will be included in the analysis of this objective. 
12.3.3.6
Confidence Interval Width
The PVS rate among all 176 ablated subjects in the TTOP-AF study was 4% 
(7/176; 95% CI:  1.6% to 8%).  Based on the added training and other mitigation 
strategies employed in this protocol to avoid PVS it is assumed that the true PVS 
rate will be 2%.  If at least 80 of the 100 subjects randomized to the PVS 
assessment cohort have readable baseline and 3-month follow-up MRI or CT-
scans and the observed PVS rate is 2% the exact 95% two-sided confidence 
should have a width no larger than 7.8% with an upper confidence boundary no 
greater than 8%.
12.3.3.7
Missing data
Subjects missing both a readable baseline and 3-month follow-up MRI or CT-scan 
will not be included in the main analysis cohort for this objective.  However, should 
the issue of missing data arise; all subjects randomized to the PVS assessment 
cohort with at least one Phased RF catheter deployed in the left atrium will be 
included in a tipping point analysis regardless of whether MRI or CT-scans are 
available.  Specifically, subjects randomized to this cohort, but missing an 
evaluable 3-month MRI or CT-scan will be included as PVS negative and iteratively 
added as PVS positive in the tipping point analysis.  
 

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15. MONITORING
It is the responsibility of Medtronic to ensure proper monitoring of the study per 
regulations.  Appropriately trained Medtronic personnel or delegates appointed by 
Medtronic will perform study monitoring at the study center in order to ensure that 
the study is conducted in accordance with the CIP, the signed Clinical Trial 
Agreement, and applicable regulatory requirements. Medtronic must therefore be 
allowed access to the subjects’ clinic and hospital records when so requested as 
per the consent form, Privacy Authorization (US only) and Clinical Trial Agreement.  
Procedures required in this CIP require source documentation. A separate 
monitoring plan will detail levels of source document verification for this study.  
15.1 Monitoring Visits
Monitoring visits will be conducted periodically to assess study progress, the 
investigator’s adherence to the CIP, regulatory compliance including but not limited 
to IRB/MEC/HREC approval and review of the study, maintenance of records and 
reports, and review of source documents against subject case report forms. 
Monitors facilitate site regulatory and study compliance by identifying findings of 
non-compliance and communicating those findings along with recommendations 
for preventive/corrective actions to site personnel. Communication with the site 
personnel occurs during the visit and following the visit via a written follow-up letter.  
Monitors may work with study personnel to determine appropriate corrective action 
recommendations and to identify trends within the study or at a particular center.  
Frequency of monitoring visits will occur based on subject enrollment, duration of 
the study, study compliance, findings from previous monitoring visits and any 
suspected inconsistency in data that requires investigation.  The amount of subject 
data monitored against source documentation is determined by type of study and 
timing of data cutoff for study deadlines. 
Storage and accountability of investigational product used for this study will be 
assessed.
15.2 Access to the Center and Study Materials
The investigator will permit study related monitoring, audits, IRB/MEC/HREC review 
and regulatory inspections by providing direct access to source data and source 
documents.
16. REQUIRED RECORDS AND REPORTS
16.1 Investigator records
The investigator is responsible for the preparation and retention of the records 
cited below. All of the below records, with the exception of case history records 
and case report forms, should be kept in the Investigator Site File (i.e., the study 
binder provided to the investigator) or Subject Study Binder. CRFs may be 
maintained and signed electronically within the electronic data capture system 

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during the study. The following records are subject to inspection and must be 
retained for a period of two years (or longer as local law or hospital administration 
requires) after product approval or the date on which the investigation is 
terminated or the date that the records are no longer required for purposes of 
supporting a pre-market approval application.

All correspondence between the IRB/MEC, sponsor, monitor, and/or the 
investigator that pertains to the investigation, including required reports.

Subject’s case history records, including: 
o
Signed and dated informed consent form: In U.S., signed by 
subject. In EEA, signed by subject and investigator.
o
Observations of adverse events/adverse device effects
o
Medical history
o
Procedure and follow-up data 
o
Documentation of the dates and rationale for any deviation from the 
protocol

Electronically signed and dated CRFs.

Device Disposition Logs containing Model numbers of devices delivered to 
the site, subject IDs of the subjects ablated, received dates of generators 
and catheters, used dates, returned-to-sponsor dates and reasons, initials 
of all persons who received, used or disposed each generator or catheter, 
and method of disposal/destruction. 

All approved versions of the Investigation Plan and Investigator 
Brochure/Report of Prior Investigations Summary 

Signed and dated Clinical Trial Agreement. 

Current curriculum vitae (signed and dated in Europe only) of principal 
investigators and key members of investigation site team

Delegated task list.

IRB/MEC approval documentation. Written information that the investigator 
or other study staff, when member of the IRB/MEC, did not participate in 
the approval process.

Study training records for site staff.

Insurance certificates as applicable

Any other records that FDA and local regulatory agencies require to be 
maintained.

Final Study Report including the statistical analysis.
16.2 Investigator reports
The investigator is responsible for the preparation (review and signature) and 
submission to the sponsor of all case report forms, adverse events and adverse 
device effects (reported per the country-specific collection requirements), deaths, 
and any deviations from the investigation plan.  If any action is taken by an 
IRB/MEC with respect to this clinical study, copies of all pertinent documentation 
must be forwarded to Medtronic in a timely manner. Reports are subject to 

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In addition, if an Ethics Board takes any action with respect to this clinical study, 
copies of all pertinent documentation must be forwarded to the sponsor in a 
timely manner.
16.3 Sponsor records
At a minimum, Medtronic shall maintain the following accurate, complete, and 
current records:

All correspondence which pertains to the investigation

Investigational device Traceability record containing Model numbers of 
devices, shipping date and name and address of person that received 
shipped device, Location (if different than person shipped to), transfer and 
receipt by Medtronic dates. (All Geographies)

Signed Investigator Trial Agreements, financial disclosure  and current 
signed and dated (Europe only)  curriculum vitae of principal investigator 
and key members of the investigation site team, delegated task list

All signed and dated case report forms submitted by investigator, including 
reports of AEs, ADEs and Device Deficiencies, and CRF corrections

Samples of informed consents, and other information provided to the 
subjects and advertisements, including translations

Copies of all IRB/MEC approval letters and relevant IRB/MEC 
correspondence and IRB/MEC voting list/roster/letter of assurance

Names of the institutions in which the clinical investigation will be 
conducted

Correspondence with authorities as required by national legislation

Insurance certificates (Europe only)

Forms for reporting any adverse events and adverse device effects

Names/contact addresses of monitors

Statistical analyses and underlying supporting data

Final report of the clinical investigation

The Clinical Investigation Plan, Investigator Brochure/Report of Prior 
Investigations summary and study related reports, and revisions

Study training records for site personnel and Medtronic personnel involved 
in the study

Forms for reporting any adverse events, adverse device effects and device 
deficiencies.

Any other records that local regulatory agencies require to be maintained.
16.4 Sponsor reports
Medtronic shall prepare and submit the following complete, accurate, and timely 
reports listed in the tables below (by geography).  In addition to the reports listed 
below, Medtronic shall, upon request of reviewing IRB/MEC, regulatory agency or 
FDA, provide accurate, complete and current information about any aspect of the 

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Version 6
VICTORY AF
Page 93 of 93
21 NOV 2014
Clinical Investigation Plan
Medtronic Confidential