Wire Instrumentation Using Radiofrequency Energy to Impact Transseptal Efficiency
Phase: NA
Conditions: Atrial Fibrillation, Atrial Flutter
Sponsor: University of California, San Francisco

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University of California, San Francisco 
Baylis Medical
WIRE IT (Wire Instrumentation using Radiofrequency Energy to Impact 
Transseptal Efficiency)
NCT04645342

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UNIVERSITY OF CALIFORNIA, SAN FRANCISCO 
BAYLIS MEDICAL
Clinical Research Protocol
WIRE IT (Wire Instrumentation using Radiofrequency Energy to Impact 
Transseptal Efficiency)
Version Date:
1.1
Nature of Study:
Investigator-initiated
Funding Organization:
Baylis Medical
Principal Investigator:
Name: Gregory M Marcus, MD, MAS 
Telephone: (415) 476-3450
Fax: (415) 353-9190
E-mail: greg.marcus@ucsf.edu
Approval:
PI or Sponsor Signature (Name and Title)
Date
This confidential information about an investigational product is provided for the exclusive use of 
investigators of this product and is subject to recall at any time. The information in this document 
may not be disclosed unless federal or state law or regulations require such disclosure. Subject to the 
foregoing, this information may be disclosed only to those persons involved in the study who have a 
need to know, with the obligation not to further disseminate this information.

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PROTOCOL AGREEMENT
I have read the protocol specified below. In my formal capacity as Investigator, my duties 
include ensuring the safety of the study subjects enrolled under my supervision and 
providing Baylis Medical with complete and timely information, as outlined in the 
protocol. It is understood that all information pertaining to the study will be held strictly 
confidential and that this confidentiality requirement applies to all study staff at this site. 
Furthermore, on behalf of the study staff and myself, I agree to maintain the procedures 
required to carry out the study in accordance with accepted GCP principles and to abide 
by the terms of this protocol.
Protocol Title: WIRE IT (Wire Instrumentation using Radiofrequency Energy to 
Impact Transseptal Efficiency)
Protocol Date: 08/26/20

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TABLE OF CONTENTS
1
BACKGROUND ..................................................................................................................4
1.1
Overview of Non-Clinical Studies...............................................................................9
1.2
Overview of Clinical Studies .......................................................................................9
2
STUDY RATIONALE.........................................................................................................9
2.1
Risk / Benefit Assessment............................................................................................9
3
STUDY OBJECTIVES........................................................................................................9
3.1
Primary Objective ........................................................................................................9
3.2
Secondary Objectives...................................................................................................9
4
STUDY DESIGN..................................................................................................................9
4.1
Study Overview............................................................................................................9
5
CRITERIA FOR EVALUATION......................................................................................10
5.1
Primary Efficacy Endpoint...........................................................................................10
5.2
Secondary Efficacy Endpoints.....................................................................................10
5.3
Safety Evaluations........................................................................................................10
5.4
Other Evaluations (include only if applicable) ............................................................10
6
SUBJECT SELECTION .....................................................................................................10
6.1
Study Population..........................................................................................................10
6.2
Inclusion Criteria..........................................................................................................10
6.3
Exclusion Criteria ........................................................................................................11
7
CONCURRENT MEDICATIONS.....................................................................................11
7.1
Allowed........................................................................................................................11
7.2
Prohibited.....................................................................................................................11
8
STUDY TREATMENTS.....................................................................................................11
8.1
Method of Assigning Subjects to Treatment Groups...................................................11
8.2
Blinding........................................................................................................................11
8.3
Test and Control Formulation......................................................................................12
8.4
Supply of Study Medication at the Site........................................................................13
8.5
Study Medication Accountability ................................................................................14
8.6
Measures of Treatment Compliance ............................................................................14
9
STUDY PROCEDURES AND GUIDELINES..................................................................14
9.1
Clinical Assessments....................................................................................................14
9.2
Clinical Laboratory Measurements (include sections as appropriate) .........................15
9.3
Pharmacokinetic Measurements ..................................................................................16
9.4
Research Laboratory Measurements (include sections as appropriate) .......................16
10 EVALUATIONS BY VISIT................................................................................................16
10.1 Visit 1 (Day/Week/Month #) .......................................................................................16
10.2 Visit 2 (Day/Week/Month # include visit window).....................................................17

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10.3 Visit 3 (Day/Week/Month # include visit window).....................................................17
10.4 Visit 4 (Day/Week/Month # include visit window).....................................................17
10.5 Visit 5 (Follow-up or Day/Week/Month # include visit window)...............................18
10.6 Early Withdrawal Visit ................................................................................................18
11 ADVERSE EXPERIENCE REPORTING AND DOCUMENTATION.........................18
11.1 Adverse Events.............................................................................................................18
11.2 Serious Adverse Experiences (SAE)............................................................................20
11.3 Protocol Defined Important Medical Findings Requiring Real Time Reporting.........20
11.4 Medical Monitoring .....................................................................................................20
11.5 Safety Management Plan..............................................................................................4
12 DISCONTINUATION AND REPLACEMENT OF SUBJECTS....................................20
12.1 Withdrawal of Subjects................................................................................................20
12.3   Replacement of Subjects..............................................................................................21
13 PROTOCOL VIOLATIONS ..............................................................................................22
14 DATA SAFETY MONITORING (OPTIONAL SECTION – INCLUDE WHEN 
APPROPRIATE)........................................................................................................................22
15 STATISTICAL METHODS AND CONSIDERATIONS ................................................22
15.1 Data Sets Analyzed ......................................................................................................22
15.2 Demographic and Baseline Characteristics..................................................................22
15.3 Analysis of Primary Endpoint......................................................................................23
15.4 Analysis of Secondary Endpoints ................................................................................23
15.5 Interim Analysis...........................................................................................................23
15.6 Sample Size and Randomization..................................................................................23
16 DATA COLLECTION, RETENTION AND MONITORING ........................................23
16.1 Data Collection Instruments.........................................................................................23
16.2 Data Management Procedures......................................................................................24
16.3 Data Quality Control and Reporting ............................................................................24
16.4 Archival of Data...........................................................................................................24
16.5 Availability and Retention of Investigational Records ................................................24
16.6 Monitoring ...................................................................................................................25
16.7 Subject Confidentiality ................................................................................................25
17 ADMINISTRATIVE, ETHICAL, REGULATORY CONSIDERATIONS ...................25
17.1 Protocol Amendments..................................................................................................25
17.2 Institutional Review Boards and Independent Ethics Committees..............................25
17.3 Informed Consent Form...............................................................................................26
17.4 Publications..................................................................................................................26
17.5 Investigator Responsibilities........................................................................................27

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LIST OF ABBREVIATIONS
AE 
CRF 
AF 
AFEQT
Questionnaire
adverse event 
case report form 
atrial fibrillation
Atrial Fibrillation Effect on QualiTy-of-life Questionnaire

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1. BACKGROUND
Transseptal puncture is a common procedure performed in the electrophysiology lab to 
facilitate catheter access and ablation in the left atrium or ventricle. This procedure is most 
commonly used for atrial fibrillation ablation, which requires two sheaths/catheters to be 
inserted into the left atrium. Puncture through the interatrial septum is typically facilitated 
using a needle, which is pushed through the fossa ovalis and into the left atrium. The 
major risk of transseptal puncture is inadvertent injury to the wall of the left atrium by the 
advancing needle and sheath assembly, potentially resulting in pericardial bleeding, 
cardiac tamponade, and even death.
2. STUDY RATIONALE
Prior studies have shown that a radiofrequency (RF) transseptal needle is superior to a 
standard, manual needle with regard to left atrial access time. Recently, a novel RF wire 
system has been developed to further enhance the speed and safety of transseptal access. 
With this technique, an atruamatic RF wire can be used to both traverse the fossa ovalis 
and shield the left atrial wall from traumatic injury secondary to the advancing sheath.
While this new RF wire system has recently become clinically available, there is no data 
substantiating its enhanced efficacy and safety compared to standard needle-based 
transseptal techniques.
3.
STUDY OBJECTIVES
Primary Objective: To determine if the Baylis Versacross RF wire results in a shorter time to 
successful transseptal puncture compared to the conventional Baylis RF needle.
Secondary Objectives:
To determine if the Baylis Versacross RF wire results in greater first attempt transseptal 
puncture success compared to the conventional Baylis RF needle.
To determine if the Baylis Versacross RF wire results in less complications compared to 
the conventional Baylis RF needle.

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To determine if the Baylis Versacross RF wire results in less right atrial needle/wire 
exchanges compared to the conventional Baylis RF needle.
4. STUDY DESIGN
This is a randomized, single blinded clinical trial comparing transseptal access using the 
Baylis Versacross RF wire versus the conventional Baylis RF needle among individuals 
undergoing atrial fibrillation catheter ablation.
Sedation, intubation, vascular access, and catheter ablation will be performed according to 
usual clinical care. Transseptal puncture will be performed using intracardiac ultrasound 
guidance. Each patient will undergo two transseptal punctures.
For participants randomized to the RF wire access system, the following equipment will 
be used:
o
VersaCross™ RF Wire (Baylis, Montreal, Canada)
o
VersaCross™ Transseptal Sheath (Baylis, Montreal, Canada)*
o
VersaCross™ Steerable Sheath (Baylis, Montreal, Canada)*
*Because the transseptal wire does not provide the same mechanical support as a RF 
needle, these sheaths and their accompanying dilators must be used with the RF wire.
For participants randomized to the RF needle, the following equipment will be used:
o
NRG® transseptal needle (Baylis, Montreal, Canada)
o
SL1 sheath (Abbott Medical, Santa Clara, California).
o
Agilis steerable sheath (Abbott Medical, Santa Clara, California)
The primary endpoint is time to complete transseptal puncture. Timing will start when the 
transseptal sheath wire is inserted into the femoral vein short sheath and will stop when 
the transseptal dilator is removed from the long sheath after placement in the left atrium. 
For each transseptal, the number of unsuccessful attempts requiring rewiring will be 
recorded. Fluoroscopy time, fluoroscopy dose, number of RF applications, procedural 
complications, and total procedural time will also be determined.

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At three months, six months, and one year after the ablation, study coordinators will 
follow up with participants and ask a series of questions remotely over the phone, or in- 
person if participants are coming to UCSF for clinical care. Total duration of subject 
participation will be one year.
5. CRITERIA FOR EVALUATION
Primary Efficacy Endpoint

Time to completion of transseptal puncture
Secondary Efficacy Endpoints

Efficacy of transseptal puncture

Number of right atrial needle/wire 
exchanges

Procedural complications including:
i. Hemodynamically significant pericardial effusion
ii. Bleeding requiring surgical intervention or 
transfusion
iii. Hypotension regarding prolonged pressor support 
after the procedure
iv. Prolonged intubation required
v. Air embolism
vi. Peripheral embolic event
vii.
Stroke
viii.
TIA
ix. Pseudoaneurysm 
x. AV fistula
xi. Hematoma
xii.
Myocardial infarction
xiii.
Death
xiv.
Migraine

Efficacy of catheter ablation procedures: time to first clinically evident sustained 
AF after employing a 3 month blanking period.

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
Safety Evaluations: incidence of adverse events
6. SUBJECT SELECTION
a. Study Population
Subjects with a diagnosis of atrial fibrillation or atrial flutter undergoing endocardial left 
atrial catheter ablation procedures who meet the inclusion and exclusion criteria will be 
eligible for participation in this study.
b. Inclusion Criteria
1.
Age ≥ 18 years
2.
Patients undergoing endocardial left atrial catheter ablation procedures using radiofrequency 
ablation catheters for atrial fibrillation or atrial flutter ablation procedures at UCSF
3.
Willing and able to provide written informed consent in English.
4.
Willing and able to comply with scheduled remote follow-up visits (through Year 1)
c. Exclusion Criteria
1.
Presence of a patent foramen ovale closure device or atrial septal defect closure 
device.
2. Cryoballoon ablation
3. IVC filter
4. Deemed not suitable by study personnel.
7. CONCURRENT MEDICATIONS
a. Allowed Medications and Treatments
Standard pharmacologic therapy for atrial fibrillation or atrial flutter is allowed. There are 
no prohibited medications.
8. STUDY TREATMENTS
a. Method of Assigning Subjects to Treatment Groups
Up to 72 eligible patients will be randomly assigned to either the (1) RF wire group or (2) 
RF needle group for transseptal puncture. The randomization codes will be generated prior 
to the start of enrollment using a computer program to create randomization assignments 
to either group 1 or group 2, using blocks of 6.
Blinding
The randomization assignments will not be known to patients. However, due to the nature 

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of the study, investigators and research staff will need to know the randomization

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assignments since investigators will be performing the ablation procedures using devices specific to 
each randomization group.
9. STUDY PROCEDURES AND GUIDELINES
A Schedule of Events representing the required testing procedures to be performed for the 
duration of the study is diagrammed in Appendix 1.
Prior to conducting any study-related activities, written informed consent and the Health 
Insurance Portability and Accountability Act (HIPAA) authorization must be signed and 
dated by the subject. If appropriate, assent must also be obtained prior to conducting any 
study-related activities.
a. Clinical Assessments
i.
Demographics
Demographic information (date of birth, gender, race) will be recorded at Screening.
ii.
Medical History
Relevant medical history, including history of current disease, other pertinent respiratory 
history, and information regarding underlying diseases will be recorded at Screening.
iii.
Adverse Events
Information regarding occurrence of adverse events will be captured throughout the study. 
Duration (start and stop dates and times), severity/grade, outcome, and treatment will be 
recorded on the case report form (CRF).
10.
EVALUATIONS BY VISIT
Visit 1: Screening
1.
Review the study with the subject and obtain informed consent and HIPAA 
authorization and assent through written paper form or DocuSign.
2.
Assign the subject a unique screening number.
3.
Record demographics data.
4.
Record medical history.
5.
Record medications subject is currently taking.
6.
Administer Atrial Fibrillation Effect on QualiTy-of-life questionnaire.
7. 
Ask questions about migraines using CRFs.
8.
Randomize subject after completion of this visit, 1 day before ablation procedure.

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Visit 2: Ablation Procedure Day
1.
Ablation procedure performed using assigned randomization group.
2.
Collect intraoperative data using CRFs.
3.
Record any adverse events.
Visit 3: Month 3 (post-study ablation)
1. Record any adverse events.
2. Record medications subject is currently taking.
3. Ask follow-up questions about migraines using CRFs.
Visit 4: Month 6 (post-study ablation)
1. Record medications subject is currently taking.
2. Ask follow-up questions about ablation procedure effectiveness using CRFs. 
3. Administer AFEQT questionnaire.
4. Ask follow-up questions about migraines using CRFs.
Visit 5: Month 12 (post-study ablation)
1. Record medications subject is currently taking.
2. Ask follow-up questions about ablation procedure effectiveness using CRFs.
3. Administer AFEQT Questionnaire.
11. ADVERSE EXPERIENCE REPORTING AND DOCUMENTATION
a. Adverse Events
An adverse event (AE) is any untoward medical occurrence in a clinical investigation of a 
patient. It does not necessarily have a causal relationship with the treatment. An AE is 
therefore any unfavorable and unintended sign (including an abnormal laboratory finding), 
symptom, or disease temporally associated with the administration of an investigational 
product, whether or not related to that investigational product. An unexpected AE is one 
of a type not identified in nature, severity, or frequency in the current Investigator’s 
Brochure or of greater severity or frequency than expected based on the information in the 
Investigator’s Brochure.
The Investigator will probe, via discussion with the subject, for the occurrence of AEs 
during each subject visit and record the information in the site’s source documents.
Adverse events will be recorded in the patient CRF. Adverse events will be described by 
duration (start and stop dates and times), severity, outcome, treatment and relation to 
study intervention, or if unrelated, the cause.

Pr ot oc ol # 2 0- 3 0 7 3 8
V er si o n #: 1. 1
V er si o n D at e: 0 8/ 2 6/ 2 0
P a g e 1 4 of 2 1
Pr ot oc ol Te m plate Effecti ve: 0 7 J A N 2 0 1 5
A E Se verit y
T he Nati o nal Ca ncer I nstit ute’s C o m m o n Ter mi n ol o g y Criteria f or A d verse E ve nts 
( C T C A E) Versi o n 3. 0 s h o ul d be use d t o assess a n d gra de A E se verit y, i ncl u di n g 
la b orat or y a b n or malities j u d ge d t o be cli nicall y si g nifica nt. T he m o difie d criteria ca n be 
f o u n d i n t he st u d y ma n ual. If t he e x perie nce is n ot c o vere d i n t he m o difie d criteria, t he 
g ui deli nes s h o w n i n Ta ble 1 bel o w s h o ul d be use d t o gra de se verit y. It s h o ul d be p oi nte d 
o ut t hat t he ter m “se vere” is a meas ure of i nte nsit y a n d t hat a se vere A E is n ot necessaril y 
seri o us.
T a ble 1. A E Se verit y Gr a di n g
Se verit y
Descri pti o n
Mil d ( 1)
Tra nsie nt or mil d disc o mf ort; n o li mitati o n i n acti vit y; n o me dical 
i nter ve nti o n or t hera p y re q uire d. T he s u bject ma y be a ware of t he si g n 
or s y m pt o m b ut t olerates it reas o na bl y well.
M o derate ( 2)
Mil d t o m o derate li mitati o n i n acti vit y, n o or mi ni mal me dical 
i nter ve nti o n/t hera p y re q uire d.
Se vere ( 3)
Mar ke d li mitati o n i n acti vit y, me dical i nter ve nti o n/t hera p y re q uire d, 
h os pitalizati o ns p ossi ble.
Life-t hreate ni n g ( 4)
T he s u bject is at ris k of deat h d ue t o t he a d verse e x perie nce as it 
occ urre d. T his d oes n ot refer t o a n e x perie nce t hat h y p ot heticall y 
mi g ht ha ve ca use d deat h if it were m ore se vere.
b. Seri o us A d verse E x perie nces ( S A E)
A n S A E is defi ne d as a n y A E t hat res ults i n a n y of t he f oll o wi n g o utc o mes:
 deat h
 a life-t hreate ni n g a d verse e x perie nce
 i n patie nt h os pitalizati o n or pr ol o n gati o n of e xisti n g h os pitalizati o n
 a persiste nt or si g nifica nt disa bilit y/i nca pacit y
 a c o n ge nital a n o mal y/ birt h defect
Ot her i m p orta nt me dical e ve nts ma y als o be c o nsi dere d a n S A E w he n, base d o n 
a p pr o priate me dical j u d g me nt, t he y je o par dize t he s u bject or re q uire i nter ve nti o n t o 
pre ve nt o ne of t he o utc o mes liste d.
i. Seri o us A d verse E x perie nce Re p orti n g
St u d y sites will d oc u me nt all S A Es t hat occ ur ( w het her or n ot relate d t o st u d y 
i nter ve nti o n) per U C S F C H R G ui deli nes . T he c ollecti o n peri o d f or all S A Es will be gi n 
after i nf or me d c o nse nt is o btai ne d a n d e n d after pr oce d ures f or t he fi nal st u d y visit ha ve 
bee n c o m plete d.

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In accordance with the standard operating procedures and policies of the local Institutional 
Review Board (IRB)/Independent Ethics Committee (IEC), the site investigator will report 
SAEs to the IRB/IEC. All AEs and SAEs will also be reported to Baylis Medical.
12.3 Withdrawal of Subjects from the Study
A subject may be withdrawn from the study at any time if the subject or the investigator 
feels that it is not in the subject’s best interest to continue.
All subjects are free to withdraw from participation at any time, for any reason, specified 
or unspecified, and without prejudice.
Reasonable attempts will be made by the investigator to provide a reason for subject 
withdrawals. The reason for the subject’s withdrawal from the study will be specified in 
the subject’s source documents.
12.4 Replacement of Subjects
Subjects who do not undergo the study ablation procedure will be replaced.
12.
PROTOCOL VIOLATIONS
A protocol violation occurs when the subject or investigator fails to adhere to significant 
protocol requirements affecting the inclusion, exclusion, subject safety and primary 
endpoint criteria. Protocol violations for this study include, but are not limited to, the 
following:
Failure to meet inclusion/exclusion criteria
Failure to comply with Good Clinical Practice (GCP) guidelines will also result in a 
protocol violation. The Investigator will determine if a protocol violation will result in 
withdrawal of a subject.
When a protocol violation occurs, it will be discussed with the investigator and a Protocol 
Violation Form detailing the violation will be generated. This form will be signed by the 
Investigator. A copy of the form will be filed in the site’s regulatory binder.
13.
STATISTICAL METHODS AND CONSIDERATIONS
a. Data Sets Analyzed
All subjects who undergo a transseptal puncture during their study ablation procedure will 
be included in the analysis.
b. Demographic and Baseline Characteristics
The following demographic variables at screening will be summarized: race, biological 
sex, gender, age, height and weight.

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c. Analysis of Primary Endpoint
The primary endpoint (transseptal time, in minutes) will be analyzed using a t-test if time 
is normally distributed and a Wilxocon rank sum test if it exhibits a skewed distribution.
d.
Sample Size and Randomization
The sample size of seventy-two patients will provide 99% power to detect a stastically 
significant difference in time assuming mean transseptal time of 5 minutes and standard 
deviation of 5 minutes using a two-tailed alpha of 0.05.
Up to 72 eligible patients will be randomly assigned to either the (1) RF wire group or (2) 
RF needle group for their transseptal puncture. The randomization codes will be generated 
prior to the start of enrollment using a computer program to create randomization 
assignments to either group 1 or group 2, using blocks of 6.
DATA COLLECTION, RETENTION AND MONITORING
e. Data Collection Instruments
The Investigator will prepare and maintain adequate and accurate source documents 
designed to record all observations and other pertinent data for each subject.
Study personnel will enter data from source documents corresponding to a subject’s visit 
into the protocol-specific electronic Case Report Form (eCRF) OR paper CRF when the 
information corresponding to that visit is available. Subjects will not be identified by 
name in the study database or on any study documents to be collected by the Sponsor (or 
designee), but will be identified by a subject number and initials.
For eCRFs: If a correction is required for an eCRF, the time and date stamps track the 
person entering or updating eCRF data and creates an electronic audit trail. For paper 
CRFs: If a correction is made on a CRF, the study staff member will line through the 
incorrect data, write in the correct data and initial and date the change.
The Investigator is responsible for all information collected on subjects enrolled in this 
study. All data collected during the course of this study must be reviewed and verified for 
completeness and accuracy by the Investigator. A copy of the CRF will remain at the 
Investigator’s site at the completion of the study.
f. Data Management Procedures
The data will be entered into a validated database. The Data Management group will be 
responsible for data processing, in accordance with procedural documentation. Database 
lock will occur once quality assurance procedures have been completed.
All procedures for the handling and analysis of data will be conducted using good 
computing practices meeting FDA guidelines for the handling and analysis of data for 
clinical trials.

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g. Data Quality Control and Reporting
After data have been entered into the study database, a system of computerized data 
validation checks will be implemented and applied to the database on a regular basis.
h. Archival of Data
The database is safeguarded against unauthorized access by established security 
procedures; appropriate backup copies of the database and related software files will be 
maintained. Databases are backed up by the database administrator in conjunction with 
any updates or changes to the database.
At critical junctures of the protocol (e.g., production of interim reports and final reports), 
data for analysis is locked and cleaned per established procedures.
i. Availability and Retention of Investigational Records
The Investigator will make study data accessible to the IRB/IEC and Regulatory Agency 
(e.g., FDA) inspectors upon request. A file for each subject must be maintained that 
includes the signed Informed Consent, HIPAA Authorization and Assent Form and copies 
of all source documentation related to that subject. The Investigator must ensure the 
reliability and availability of source documents from which the information on the CRF 
was derived.
14.
ADMINISTRATIVE, ETHICAL, REGULATORY CONSIDERATIONS
The study will be conducted according to the Declaration of Helsinki, Protection of 
Human Volunteers (21 CFR 50), Institutional Review Boards (21 CFR 56), and 
Obligations of Clinical Investigators (21 CFR 312).
To maintain confidentiality, all laboratory specimens, evaluation forms, reports and other 
records will be identified by a coded number and initials only. All study records will be 
kept in a locked file cabinet and code sheets linking a patient’s name to a patient 
identification number will be stored separately in another locked file cabinet. The 
Investigator will also comply with all applicable privacy regulations (e.g., Health 
Insurance Portability and Accountability Act of 1996, EU Data Protection Directive 
95/46/EC).
a. Protocol Amendments
Any amendment to the protocol will be written by the Principal Investigator. Protocol 
amendments cannot be implemented without prior written IRB/IEC approval except as 
necessary to eliminate immediate safety hazards to patients. A protocol amendment 
intended to eliminate an apparent immediate hazard to patients may be implemented 
immediately, provided the IRBs are notified within five working days.

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b. Institutional Review Boards and Independent Ethics Committees
The protocol and consent form will be reviewed and approved by the IRB/IEC prior to 
study initiation. Serious adverse experiences regardless of causality will be reported to 
the IRB/IEC in accordance with the standard operating procedures and policies of the 
IRB/IEC, and the Investigator will keep the IRB/IEC informed as to the progress of the 
study. The Investigator will obtain assurance of IRB/IEC compliance with regulations.
Any documents that the IRB/IEC may need to fulfill its responsibilities (such as protocol, 
protocol amendments, Investigator’s Brochure, consent forms, information concerning 
patient recruitment, payment or compensation procedures, or other pertinent information) 
will be submitted to the IRB/IEC. The IRB/IECs written unconditional approval of the 
study protocol and the informed consent form will be in the possession of the Investigator 
before the study is initiated.
The IRB/IEC must be informed of revisions to other documents originally submitted for 
review; serious and/or unexpected adverse experiences occurring during the study in 
accordance with the standard operating procedures and policies of the IRB; new 
information that may affect adversely the safety of the patients of the conduct of the study; 
an annual update and/or request for re-approval; and when the study has been completed.
c. Informed Consent Form
Informed consent will be obtained in accordance with the Declaration of Helsinki, ICH 
GCP, US Code of Federal Regulations for Protection of Human Subjects (21 CFR 
50.25[a,b], CFR 50.27, and CFR Part 56, Subpart A), the Health Insurance Portability and 
Accountability Act (HIPAA, if applicable), and local regulations.
A properly executed informed consent will be obtained from each subject via a written 
consent document or DocuSign consent prior to entering the subject into the trial.
Information should be given in both oral and written form and subjects (or their legal 
representatives) must be given ample opportunity to inquire about details of the study. A 
copy of the signed consent form (and assent) will be given to the subject or legal 
representative of the subject and the original will be maintained with the subject’s records.
d. Publications
The preparation and submittal for publication of manuscripts containing the study results 
shall be in accordance with a process determined by mutual written agreement among the 
Principal Investigator and Baylis. The publication or presentation of any study results 
shall comply with all applicable privacy laws, including, but not limited to, the Health 
Insurance Portability and Accountability Act of 1996.
e. Investigator Responsibilities
By signing the Agreement of Investigator form, the Investigator agrees to:
1.
Conduct the study in accordance with the protocol, except when to protect the safety, 
rights or welfare of subjects.

Protocol #20-30738
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2. Personally conduct or supervise the study (or investigation).
3. Ensure that the requirements relating to obtaining informed consent and IRB review 
and approval meet federal guidelines, as stated in § 21 CFR, parts 50 and 56.
4. Report to the IRB AEs that occur in the course of the study, in accordance with §21 
CFR 312.64.
5.
Ensure that all associates, colleagues and employees assisting in the conduct of the 
study are informed about their obligations in meeting the above commitments.
6.
Maintain adequate and accurate records in accordance with §21 CFR 312.62.
7.
Ensure that an IRB that complies with the requirements of §21 CFR part 56 will be 
responsible for initial and continuing review and approval of the clinical study.
8.
Promptly report to the IRB all changes in the research activity and all unanticipated 
problems involving risks to subjects or others (to include amendments and IND 
safety reports).
9.
Seek IRB approval before any changes are made in the research study, except 
when necessary to eliminate hazards to the patients/subjects.
10. Comply with all other requirements regarding the obligations of clinical 
investigators and all other pertinent requirements listed in § 21 CFR part 312.

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APPENDIX 1: SCHEDULE OF STUDY VISITS
VISIT 1
(Screening)
VISIT 2
(Ablation Procedure 
Day)
VISIT 3
(3 Month (post-study 
ablation))
VISIT 4
(6 Months (post-study 
ablation))
VISIT 5
(1 Year (post-study 
ablation))
Informed Consent
X
Medical History
X
Complete Physical Exam
Abbreviated Physical Exam
Height
Weight
Vital Signs
Oximetry
Spirometry
Pharmacokinetics
Chemistry
Pregnancy Test (Urine or Serum)
Hematology
ESR
C-Reactive Protein
Urinalysis
Randomization
X (DAY BEFORE 
ABLATION)
Dispensing or Administration of 
Study Drug
Counting of Returned Study Drug
Initiate Subject Diary
Subject Diary Review
Concomitant Medication Review

P a g e 2 0 of 2 1
A d verse E x perie nces
X
X
X
X
A F E Q T
X
X
X
a
2 da ys

1.
Marcus GM, Ren X, Tseng ZH, et al. Repeat transseptal catheterization after 
ablation for atrial fibrillation. J Cardiovasc Electrophysiol. 2007;18(1):55-59.
2.
Ross J, Jr. Transseptal left heart catheterization a 50-year odyssey. J Am Coll 
Cardiol. 2008;51(22):2107-2115.
3.
Calkins H, Hindricks G, Cappato R, et al. 2017 
HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and 
surgical ablation of atrial fibrillation. Heart Rhythm. 2017;14(10):e275-e444.
4.
Hsu JC, Badhwar N, Gerstenfeld EP, et al. Randomized trial of conventional 
transseptal needle versus radiofrequency energy needle puncture for left atrial 
access (the TRAVERSE-LA study). J Am Heart Assoc. 2013;2(5):e000428.
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Version Date: 08/26/20
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Protocol Template © CFFT TDN Effective: 12 SEP 2007