ABLATOR Ablation Observational Registry
Conditions: Atrial Fibrillation
Sponsor: Abbott Medical Devices

 
Clinical Investigation Plan Cover Page 
 
 
 
. 
87173 CIP Posting Cover Page Ver B 
Template 
 
 
 
 
 
 
 
NCT Number: NCT02344173 
ABLATOR 
Ablation Observational Registry 
Study Document No: SJM-CIP-10032 
Version B 
Date: 20-Oct-2015 
 
 
Sponsor  
 
 
St. Jude Medical International, Inc. 
        
 
 
 
The Corporate Village 
 
 
 
 
Da Vincilaan 11 – box F1 
 
 
 
 
B-1935 Zaventem 
 
 
 
 
Belgium 
 
 
 
 
 
 
 
 
 
 

           
Clinical Protocol – ABLATOR
 
 
SJM-CIP-10032 Ver. B 
  
ABLATOR Study 
October 20, 2015 
1 of 15 
 
 
 
 
CRD N° 
: CRD_723 
Project Acronym 
: ABLATOR 
Project Version 
: Ver. B 
Version Date 
: 20OCT2015 
 
 
ABLATOR Ablation Observational Registry  
 
Protocol 
 
CRD_723 
 
 
 
Sponsor 
SJM International, Inc. 
The Corporate Village 
Da Vincilaan 11 – box F1 
B-1935 Zaventem  
Belgium 
Tel: +32 2 774 69 37 
Fax: +32 2 774 69 46 
Clinical Director 
Signature 
 
Date 
 
 
Clinical Coordinating  
Investigator  
 
 
Atul Verma, MD FRCPC 
Staff Cardiology, Electrophysiology 
Southlake Regional Health Centre 
712 Davis Drive - Suite 105 
Newmarket, Ontario, Canada, L3Y 8C3 
 
 
Signature 
 
Date 
 
2014 - SJM International, Inc.: All rights reserved. No portion of this work may be reproduced in 
whole or in part without the express written permission of SJM international, Inc. 

           
Clinical Protocol – ABLATOR
 
 
SJM-CIP-10032 Ver. B 
  
ABLATOR Study 
October 20, 2015 
2 of 15 
 
 
 
 
 
 
Table of Contents 
 
1 
Background ......................................................................................................................... 4 
2 
Registry Design ................................................................................................................... 4 
2.1 
Purpose .........................................................................................................................................................4 
2.2 
Objectives ......................................................................................................................................................4 
2.3 
Investigation Type .........................................................................................................................................5 
2.4 
Subject Population .........................................................................................................................................5 
Point of Enrollment .............................................................................................................. 5 
Expected duration of each subject’s participation ................................................................ 5 
Expected duration of the registry ......................................................................................... 5 
Number of Patients required to be included in the registry ................................................... 5 
2.5 
Devices Used ................................................................................................................................................5 
3 
Data collection ..................................................................................................................... 6 
3.1 
Registry Flow Chart .......................................................................................................................................6 
3.2 
Case Report Forms Content ..........................................................................................................................7 
Enrollment & Informed Consent Process ............................................................................. 8 
Baseline Visit ....................................................................................................................... 8 
Ablation procedure .............................................................................................................. 9 
6 and 12 Month Follow-up (+/- 30 days) .............................................................................. 9 
4 
Registry Conduct ............................................................................................................... 10 
4.1 
Sponsor obligations ..................................................................................................................................... 10 
4.2 
Investigator obligations ................................................................................................................................ 11 
4.3 
Monitoring .................................................................................................................................................... 11 
4.4 
Investigation Termination ............................................................................................................................ 11 
4.5 
Statement of Compliance ............................................................................................................................ 11 
5 
Risks and Benefits of the clinical investigation ................................................................... 12 
6 
Statistical considerations ................................................................................................... 12 
7 
Data Management ............................................................................................................. 12 
8 
Document Retention .......................................................................................................... 12 
9 
Amendments ..................................................................................................................... 13 
10 
Publication Policy .............................................................................................................. 13 
11 
Bibliography ....................................................................................................................... 13 
Appendix A: Data Collection Method ......................................................................................... 15 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

           
Clinical Protocol – ABLATOR
 
 
SJM-CIP-10032 Ver. B 
  
ABLATOR Study 
October 20, 2015 
3 of 15 
 
 
 
 
Revision History 
Amendment 
N° 
Project Version 
Date 
Rationale 
Details 
NAP 
Ver. A 
17SEP2014 
Initial release  
NAP 
NAP 
Ver. B 
19OCT2015 
Increase to 2000 patients and 100 
centers. Added US as a potential 
geography.  Updated section 6  
statistical considerations.  Added 
2 objectives. 
NAP 
 
 
 
 

           
Clinical Protocol – ABLATOR
 
 
SJM-CIP-10032 Ver. B 
  
ABLATOR Study 
October 20, 2015 
4 of 15 
 
 
 
1 Background 
 
Atrial Fibrillation (AF) prevalence in the western world is high and increasing, from 0.9%1up to 
24.2% in men over 85 years2.  These estimates are consistent with earlier US based data, which 
indicate that the number of individuals with AF is expected to double between now and 2050.  
 
AF ablation is now recognized as a second line therapy3, sometimes used as primary therapy 
prior to failure of an antiarrhythmic drug (AAD)4.  The most common approach to AF ablation is 
based on Pulmonary Vein Isolation (PVI), but multiple alternate approaches are being used and 
studied (i.e. lines, complex fractionated electrograms (CFE), rotors, epicardial approach). 
 
Radiofrequency (RF) energy is still predominantly used, with 3D mapping for both anatomical 
navigation and electrical mapping. 
 
St. Jude Medical (SJM) provides a wide range of devices that can be used during atrial 
fibrillation (AF) ablation procedures and has recently introduced new devices such as the 
FlexAbility Ablation catheter with enhanced maneuverability and innovative irrigation and 
TactiCath Ablation Catheter with contact force sensing5. 
 
Multiple papers address the treatment of AF from a clinical perspective6-9.  This registry aims at 
collecting a large sample of real world cases focusing on the synergy between various tools and 
investigating their impact on procedural and clinical effectiveness. The outcomes will support 
recommendations for optimal techniques, evaluate overall procedural costs, provide feedback to 
designers for improved tools, create supporting data for randomized controlled trials designs and 
provide information on operator’s choices from a vast variety of sites.   
 
2 Registry Design 
2.1 Purpose 
The purpose of this registry is to assess the performance and clinical effectiveness of a 
combination of SJM mapping and ablation products in the treatment of subjects with atrial 
fibrillation (AF. 
2.2 Objectives 
- 
To confirm patient safety as part of the post market surveillance study. 
- 
To assess performance of a combination of SJM products during procedures  
- 
To assess the learning curve with a combination of SJM products. 
- 
To collect operator feedback on a combination of SJM products  
- 
To compare the acute and long-term effectiveness according to technique used. 
- 
To analyze procedure efficiency according to technique used. 
 
 
 
2.3 Investigation Type 
Post-market, international, multi-center, prospective, single arm observational registry. 

           
Clinical Protocol – ABLATOR
 
 
SJM-CIP-10032 Ver. B 
  
ABLATOR Study 
October 20, 2015 
5 of 15 
 
 
 
This observational registry will be conducted in approximately 100 centers worldwide.  
2.4 Subject Population 
All patients from participating sites who are indicated for an atrial fibrillation ablation procedure 
and willing to provide written Informed Consent may be enrolled in this registry.  
Point of Enrollment 
Patients are considered enrolled in this registry following provision of written Patient Informed 
Consent. 
 
Expected duration of each subject’s participation 
The expected duration of each subject’s participation is 1 year. 
Expected duration of the registry 
The expected duration of this registry is approximately 3 years: 2 years of enrollment and 1 
additional year of follow up. 
Number of Patients required to be included in the registry 
Up to 2,000 patients will be enrolled in this registry. 
 
2.5 Devices Used 
In order to ensure a minimum level of uniformity across site practices and to enable comparison 
of acute and long-term effectiveness as well as procedure efficiency according to technique 
used, a combination of 2 types of devices from the pre-specified list must be used to be eligible 
in this registry. 
 
List of devices to be used in this registry: 
Combination of a minimum of 2 devices amongst: 
 
Europe, Middle East Canada, Australia and New Zealand  
• 
Ablation catheter: TactiCath or FlexAbility  
• 
Access with steerable sheath: Agilis NxT 
• 
Versatile diagnostic catheters: Inquiry Afocus II DL, Optima or Reflexion Spiral 
In case of advanced mapping, EnSite Velocity must be used. 
 
US 
• 
Ablation catheter: TactiCath  
• 
Access with steerable sheath: Agilis NxT 
• 
Versatile diagnostic catheters: Inquiry Afocus II DL, Optima or Reflexion Spiral 
In case of advanced mapping, EnSite Velocity must be used. 
 
 
 
 


&OLQLFDO3URWRFRO±$%/$725


6-0&,39HU%

$%/$7256WXG\
2FWREHU
RI



$VLD
x
$EODWLRQFDWKHWHU)DPLO\RI7KHUDS\&RRO)OH[FDWKHWHUV
x
$FFHVVZLWKVWHHUDEOHVKHDWK$JLOLV1[7
x
9HUVDWLOHGLDJQRVWLFFDWKHWHUV,QTXLU\$IRFXV,,'/2SWLPDRU5HIOH[LRQ6SLUDO
,QFDVHRIDGYDQFHGPDSSLQJ(Q6LWH9HORFLW\PXVWEHXVHG

2QO\6-0FRPPHUFLDOO\DYDLODEOHVKHOIVWRFNZLOOEHXVHGIRUWKH5HJLVWU\7KHPDQXDOVVKLSSHG
ZLWKWKH6-0GHYLFHVVKRXOGEHFRQVXOWHG6XFFHVVRUPRGHOVRIWKHFXUUHQWDSSURYHGGHYLFHV
FDQEHXVHGDVZHOORQFHWKH\EHFRPHDYDLODEOHDQGPDUNHWDSSURYHG
 'DWDFROOHFWLRQ
 5HJLVWU\)ORZ&KDUW
)LJXUH)ORZ&KDUW


$OOSURFHGXUHVZLOOIROORZVLWHVWDQGDUGRIFDUHDWWKHVLWH





















Enrollment
ͻPatient 
informed 
consent
Baseline
ͻPatient history
Procedure
ͻProcedure
ͻOperator 
feedback
Follow-up
ͻMandatory 
telephone or 
hospital FUP at 
6 and 12 
months

           
Clinical Protocol – ABLATOR
 
 
SJM-CIP-10032 Ver. B 
  
ABLATOR Study 
October 20, 2015 
7 of 15 
 
 
 
 
 
 
 
3.2 Case Report Forms Content 
 
Table 1: Data Collection  
 
                   Visit 
 
 
CRFs  
Enrollment & 
Baseline 
 
Ablation 
Procedure 
 
6 and 12 
Months 
Enrollment:  
Informed Consent Process 
X 
 
 
Baseline:  
Demographics, 
Cardiovascular History, AF 
History, Medical History 
X 
 
 
Ablation procedure  
 
X 
 
Device user experience 
 
X 
 
Follow Up Log* 
 
 
X 
Repeat procedure 
 
 
(X) 
Cardiovascular Serious 
Adverse Event 
(X) 
(X) 
(X) 
Withdrawal 
(X) 
(X) 
(X) 
Death 
(X) 
(X) 
(X) 
(X) if applicable 
* Telephone or office visit 
 
 

           
Clinical Protocol – ABLATOR
 
 
SJM-CIP-10032 Ver. B 
  
ABLATOR Study 
October 20, 2015 
8 of 15 
 
 
 
Enrollment & Informed Consent Process 
The investigator is responsible for screening subjects for this registry and for obtaining patient 
informed consent, as applicable per local regulations.  Provision of the Informed Consent is 
mandatory.  Informed Consent is required from all patients (or their legal representatives) prior 
to participation in the investigation.  The process of obtaining Informed consent shall comply with 
the most recent version of the declaration of Helsinki, ISO 14155 and all applicable regulations.  
The principal investigator or his/her authorized designee will conduct the Informed Consent 
Process.  This process will include a verbal discussion with the patient on all aspects of the 
clinical investigation that are relevant to the patient’s decision to participate in the clinical 
investigation.  It is crucial that this discussion is documented in the source documents (read 
hospital records of the patient). 
 
The patient will be provided with the informed consent form that is written in a language that is 
understandable to the patient and has been approved by Ethics Committee.  The patient is given 
ample time to consider participation and ask questions if necessary. 
 
In order to avoid any possible coercion or undue improper influence on, or inducement of the 
patient to participate, the Sponsor requests the investigator to only sign the informed consent 
form once the patient has signed and dated the document and therefore decided to participate in 
the investigation. 
 
Informed Consent of a patient shall always be indicated by personally dated signature of the 
patient and by the investigator responsible for conducting the informed consent process.  It is 
crucial that the signature of the informed consent is documented in the source documents (read 
hospital records of the patient). 
 
One original signed consent document must be retained on file by the investigator and a second 
original signed consent document is provided to the subject (investigator’s responsibility). 
The patient’s legal rights will not be waived nor the appearance that these will be waived.  Native 
non-technical language, understandable for the patient, will be used.  Important new information 
that becomes available throughout the Registry will have to be provided in writing to new and 
existing patients.  If relevant, all affected patients shall be asked to confirm their continuing 
informed consent in writing. 
Baseline Visit  
The following baseline information will be collected; 
- 
 Patient demographics  
- 
Atrial fibrillation History (such as type, frequency, duration of atrial fibrillation and other 
arrhythmias other than AF),  
- 
Cardiovascular history (NYHA class, LA diameter, LV EF% and degree of valvular heart 
disease),  
- 
Cardiac medical history (pre-existing cardiac conditions and cardiac procedures).  
 

           
Clinical Protocol – ABLATOR
 
 
SJM-CIP-10032 Ver. B 
  
ABLATOR Study 
October 20, 2015 
9 of 15 
 
 
 
 
 
Ablation procedure 
- 
Devices used 
- 
Ablation parameters 
- 
Ablation success definition and result 
- 
Operator feedback (Device combination chosen, device maneuverability, ease of use in 
combination with other device) 
- 
Number, experience and type of attending personnel 
- 
Definition of standard of care (follow-up procedures and occurrence) 
6 and 12 Month Follow-up (+/- 30 days) 
- 
Recurrence of atrial arrhythmias: list of atrial arrhythmias since last visit, classify episodes, 
duration of the episodes, (only events with source data evidence are to be recorded).  
- 
Changes in therapy (new antiarrhythmic drug, redo procedures). 
- 
In case of Repeat Ablation Procedures, reconnections and new ablations will be recorded. 
Cardiovascular Serious Adverse Event  
An adverse event is reportable in this registry when the event is deemed of cardiovascular origin 
and has the potential of leading to: 
- 
Death 
- 
A serious deterioration in the health of the subject, that can either result in: 
o A life-threatening illness or injury OR 
o A permanent impairment to a body structure or a body function OR 
o An in-patient or prolonged hospitalization OR 
o A medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function OR 
o A malignant tumor 
- 
Fetal distress, fetal death or a congenital abnormality or birth defect 
 
A planned hospitalization for a pre-existing condition is not considered a serious adverse event. 
 
Potential Cardiovascular Serious Adverse Events (SAEs) include but are not limited to the 
following: 
 
Abnormal ECG, Angina (chest pain), Arrhythmia, AV fistula, Complete heart block, Coronary 
artery injury, Cardiac perforation, Cardiac Thromboembolism, CHF exacerbation – fluid 
overload, Component damage to ICD or implantable pacemaker, Death, Dislodgement of 
implantable cardiovertor defibrillator of permanent pacing lead, Endocarditis, Exacerbation of 
pre-existing atrial fibrillation, Heart Failure, Hypotension, Inadvertent AV block (complete heart 
block), Left atrial/esophageal fistula, Myocardial infarction, Obstruction/perforation/damage of 
the vascular system, Palpitation, Pericardial effusion/cardiac tamponade, Pericardial effusion 
without tamponade, Pericarditis, Pulmonary vein dissection, Pulmonary vein stenosis, 
Pulmonary vein thrombus, Temporary or complete heart block, Unintended (in)complete AV, 
sinus node, heart block/damage, Vessel wall/valvular damage or insufficiency and Ventricular 
arrhythmia requiring defibrillation. 
 
 

           
Clinical Protocol – ABLATOR
 
 
SJM-CIP-10032 Ver. B 
  
ABLATOR Study 
October 20, 2015 
10 of 15 
 
 
 
Procedure for assessing, recording and reporting SAEs: 
 
Cardiovascular SAEs must be reported following local regulation, no later than 7 days from site 
being made aware of the event. All cardiovascular SAEs between patient enrollment and end of 
registry must be reported to the sponsor and to the local ethics committees, as per local 
regulations. 
 
Should an SAE occur, complete and submit an Adverse Event form to St. Jude Medical.  
 
Additional information can be requested, if necessary, by the Sponsor for reporting of SAEs to 
regulatory authorities. The investigator must notify the Ethics Committee, if appropriate, in 
accordance with national and local laws and regulations. 
Death  
All patient deaths that occur during this registry must be reported to SJM within 72 hours of the 
center becoming aware of the death.  An Adverse Event form should be completed for all deaths 
at all sites.  
Protocol Deviations 
Investigators are required to adhere to the study protocol, signed Investigator’s Agreement, 
applicable federal (national) or state/local, laws and regulations, and any conditions required by 
the Ethics Committee or applicable regulatory authorities.  A protocol deviation is used to 
describe situations in which the study protocol was not followed.  All deviations from the study 
protocol must be reported to SJM.  
Withdrawals  
All reasonable efforts should be made to retain the patient in the Registry.  If a patient concludes 
their participation in the registry, the patient’s future management will not be changed by this 
decision, whether it is voluntary or otherwise.  Should a patient withdraw and conclude 
participation in the registry, document the information in the withdrawal form (CRF) as soon as 
possible.   
 
4 Registry Conduct 
4.1 Sponsor obligations 
 
 Sponsor personnel will: 
- 
Propose the registry to participating sites 
- 
Train and provide the site personnel with access and training to an Electronic Data Capture 
platform 
- 
Monitor subject data collected in the registry 
 
 

           
Clinical Protocol – ABLATOR
 
 
SJM-CIP-10032 Ver. B 
  
ABLATOR Study 
October 20, 2015 
11 of 15 
 
 
 
4.2 Investigator obligations 
The principal investigator and delegates are required to adhere to the Protocol in order to 
prevent subjects being exposed to unreasonable risks.  On top of that, the principal investigator 
and delegates are required to be compliant with the signed Study Agreement, applicable 
national or local laws and regulations, and any conditions required by the appropriate Ethics 
Committee 
 
4.3 Monitoring  
Centralized monitoring will occur through routine internal data review.  This monitoring is 
designed to identify missing and inconsistent data, data outliers, and potential protocol 
deviations that may be indicative of site non-compliance.  On site monitoring may occur at the 
discretion of the sponsor. 
4.4 Investigation Termination 
The Sponsor reserves the right to stop the registry at any stage, with appropriate written notice 
to the investigator.  
Possible reasons for early termination of the registry by the sponsor, either at local, national or 
international level, may include, but are not limited to: 
 
• 
Sponsor’s decision 
• 
Request from Regulatory bodies 
• 
Request of Ethics Committee(s) 
• 
Occurrence of unanticipated SAE related to a device which cannot be prevented in future 
cases 
 
If applicable the registry will be terminated according to applicable regulations. 
 
4.5 Statement of Compliance 
 
The registry will be performed in accordance with the most current versions of the World Medical 
Association (WMA) Declaration of Helsinki, ISO 14155 and any regional and/or national 
regulations and will be compliant to this International Standard and any regional and national 
regulations, as appropriate. 
 
The investigator shall not start enrolling patients or requesting informed consent from any patient 
prior to obtaining Ethics Committee approval and Competent Authority approval, if applicable, 
and authorization from the sponsor in writing. 
 
 
In case additional requirements will be imposed by the Ethics Committee or Competent Authority 
they shall be followed, if appropriate. 
 

           
Clinical Protocol – ABLATOR
 
 
SJM-CIP-10032 Ver. B 
  
ABLATOR Study 
October 20, 2015 
12 of 15 
 
 
 
5 Risks and Benefits of the clinical investigation 
This registry will follow site standard practice procedures, therefore there are no risks or benefits 
associated with participating in this registry for the patient. A long term benefit for therapy 
delivery is expected based on the scientific outcome of the registry data analysis. 
 
6 Statistical considerations 
This is a post-market, international, multi-center, single arm observational registry. The 
objectives of this Registry are as follows: 
 
- 
To confirm patient safety as part of the post market surveillance study. 
- 
To assess performance of a combination of SJM products during procedures  
- 
To assess the learning curve with a combination of SJM products. 
- 
To collect operator feedback on a combination of SJM products  
- 
To compare the acute and long-term effectiveness according to technique used. 
- 
To analyze procedure efficiency according to technique used. 
 
 
Up to 2,000 patients will be enrolled in this registry, which is expected to be adequate to address 
the objectives of this registry.  Descriptive statistics will be used to summarize baseline and 
demographic data, procedural information, adverse events and recurrence of atrial arrhythmias.  
Continuous variables may be summarized using either mean, standard deviation and range, or 
median and interquartile range as applicable.  Categorical variables will be summarized as 
frequencies and proportions.  Kaplan-Meier time to event analysis may be used to summarize 
recurrent atrial arrhythmias.  To assess learning curve, appropriate statistical analysis will be 
used to assess the influence of physician experience on procedural outcomes or adverse 
events.  
 
7 Data Management 
Data from this registry will be analyzed by SJM and may be transferred SJM’s locations outside 
of Europe and/or any other worldwide regulatory authority in support of a market-approval 
application. 
 
The physician is required to enter the data through an electronic data capture (EDC) system 
within 10 days of the visit.  
 
8 Document Retention 
The principal investigator (PI) shall maintain a copy of all registry records (e.g., informed consent 
documents, Registry records, etc.) which support CRFs of this registry, must be retained in the 
files of the responsible Investigator for a minimum of 15 years following notification by SJM that 
all Investigations (not merely the Investigators portion) are completed, terminated, or 
discontinued.   
If the participating physician retires, relocates, or for other reasons withdraws from the 

           
Clinical Protocol – ABLATOR
 
 
SJM-CIP-10032 Ver. B 
  
ABLATOR Study 
October 20, 2015 
13 of 15 
 
 
 
responsibility of keeping the registry records, custody must be transferred to a person who will 
accept responsibility.  SJM must be notified in writing of the name and address of the new 
custodian.  
 
9 Amendments  
This protocol, Case Report Forms (CRFs), Informed Consent form, other patient information, or 
other Registry documents shall be amended as needed throughout the registry. A justification 
statement shall be included with each amended section of a document.  The amendments to the 
protocol and the subject’s Informed Consent shall be notified to, or approved by, the Ethic 
Committees and regulatory authorities, if required. The version number and date of amendments 
shall be documented. 
 
10 Publication Policy 
The Investigator shall strictly comply with the Publication agreement related to “Ablator registry”. 
 
SJM is the legal owner of the entire Clinical Study database.  Decisions on the timing and 
content of Publication(s) from the Registry will be coordinated by SJM. 
 
11 Bibliography  
1.  Murphy NF, Simpson CR, Jhund PS, Stewart S, Kirkpatrick M, Chalmers J, et al. A national 
survey of the prevalence, incidence, primary care burden and treatment of atrial fibrillation in 
Scotland. Heart Br Card Soc. 2007 May;93(5):606–12.  
2.  Krijthe BP, Kunst A, Benjamin EJ, Lip GYH, Franco OH, Hofman A, et al. Projections on the 
number of individuals with atrial fibrillation in the European Union, from 2000 to 2060. Eur 
Heart J. 2013 Sep;34(35):2746–51.  
3.  Calkins H, Kuck KH, Cappato R, Brugada J, Camm AJ, Chen S-A, et al. 2012 
HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial 
fibrillation: recommendations for patient selection, procedural techniques, patient 
management and follow-up, definitions, endpoints, and research trial design: a report of the 
Heart Rhythm Society (HRS) Task Force on Catheter and Surgical Ablation of Atrial 
Fibrillation. Developed in partnership with the European Heart Rhythm Association (EHRA), 
a registered branch of the European Society of Cardiology (ESC) and the European Cardiac 
Arrhythmia Society (ECAS); and in collaboration with the American College of Cardiology 
(ACC), American Heart Association (AHA), the Asia Pacific Heart Rhythm Society (APHRS), 
and the Society of Thoracic Surgeons (STS). Endorsed by the governing bodies of the 
American College of Cardiology Foundation, the American Heart Association, the European 
Cardiac Arrhythmia Society, the European Heart Rhythm Association, the Society of 
Thoracic Surgeons, the Asia Pacific Heart Rhythm Society, and the Heart Rhythm Society. 
Heart Rhythm Off J Heart Rhythm Soc. 2012 Apr;9(4):632–696.e21.  

           
Clinical Protocol – ABLATOR
 
 
SJM-CIP-10032 Ver. B 
  
ABLATOR Study 
October 20, 2015 
14 of 15 
 
 
 
4.  Hunter RJ, Berriman TJ, Diab I, Kamdar R, Richmond L, Baker V, et al. A randomized 
controlled trial of catheter ablation versus medical treatment of atrial fibrillation in heart 
failure (the CAMTAF trial). Circ Arrhythm Electrophysiol. 2014 Feb;7(1):31–8.  
5.  Kuck K-H, Reddy VY, Schmidt B, Natale A, Neuzil P, Saoudi N, et al. A novel radiofrequency 
ablation catheter using contact force sensing: Toccata study. Heart Rhythm Off J Heart 
Rhythm Soc. 2012 Jan;9(1):18–23.  
6.  Deshmukh A, Patel NJ, Pant S, Shah N, Chothani A, Mehta K, et al. In-hospital 
complications associated with catheter ablation of atrial fibrillation in the United States 
between 2000 and 2010: analysis of 93 801 procedures. Circulation. 2013 Nov 
5;128(19):2104–12.  
7.  Mont L, Bisbal F, Hernández-Madrid A, Pérez-Castellano N, Viñolas X, Arenal A, et al. 
Catheter ablation vs. antiarrhythmic drug treatment of persistent atrial fibrillation: a 
multicentre, randomized, controlled trial (SARA study). Eur Heart J. 2014 Feb;35(8):501–7.  
8.  Sohns C, Karim R, Harrison J, Arujuna A, Linton N, Sennett R, et al. Quantitative Magnetic 
Resonance Imaging Analysis of the Relationship between Contact Force and Left Atrial Scar 
Formation after Catheter Ablation of Atrial Fibrillation. J Cardiovasc Electrophysiol. 2013 Oct 
3.  
9.  Wakili R, Clauss S, Schmidt V, Ulbrich M, Hahnefeld A, Schüssler F, et al. Impact of real-
time contact force and impedance measurement in pulmonary vein isolation procedures for 
treatment of atrial fibrillation. Clin Res Cardiol Off J Ger Card Soc. 2014 Feb;103(2):97–106.  
 
10.  Arbelo E, Brugada J, Hindricks G, Maggioni AP, Tavazzi L, Vardas P, et al. The Atrial 
Fibrillation Ablation Pilot Study: an European Survey on Methodology and results of catheter 
ablation for atrial fibrillation conducted by the European Heart Rhythm Association. Eur 
Heart J. 2014 Jun 7;35(22):1466–78. 
 
 
 

           
Clinical Protocol – ABLATOR
 
 
SJM-CIP-10032 Ver. B 
  
ABLATOR Study 
October 20, 2015 
15 of 15 
 
 
 
Appendix A: Data Collection Method  
 
 
Sponsor/Investigators are required to prepare and maintain adequate and accurate case 
histories to record all observations and other data pertinent to the investigation on each subject.  
Source documents include all original records from which CRFs derive their data.  Worksheets 
can be provided. The purpose of these worksheets is to aid investigators in the capture of 
clinical investigational data and ensure all protocol required data, which is not captured in 
medical records, is recorded to support data for the investigation. These worksheets will not be a 
copy of the CRFs, but will contain entry blanks for study required data not routinely collected by 
the investigators.  All documentation pertaining to clinical assessments and medical evaluations 
should be signed and dated by the appropriate clinical personnel.  Electronic Data Capture 
(EDC) will be used for this investigation.