056-F275, Clinical Investigation Plan Template, Version 2.0 Page 1 of 115

056-F275, Clinical Investigation Plan Template, Version 2.0

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Clinical Investigation Plan

Clinical Investigation Plan/Study Title STOP Persistent AF

Study Product Name Arctic Front AdvanceTM Cardiac CryoAblation Catheter Freezor MAX? Cardiac CryoAblation Catheter

Sponsor/Local Sponsor

United States of America Medtronic, Inc. 8200 Coral Sea Street NE Mounds View, MN 55112 United States of America

Canada Medtronic of Canada, Ltd. 99 Hereford Street Brampton, Ontario, L6Y 0R3 Canada

Europe Medtronic, Bakken Research Center B.V. Endeplosdomein 5 6229 GW Maastricht The Netherlands

Japan Medtronic Japan Co. Ltd. 1-2-70 Konan Minato-ku, Tokyo 108-0075 Japan

Document Version 4, 10NOV2016

Lead Co-Principal Investigator(s)/Coordinating Investigators

Hugh Calkins, MD Address: Johns Hopkins, 1800 Orleans Street, Zayed Tower 712R, Baltimore, MD 21287 Telephone: 410-955-7405 Fax: 410-614-1345

Professional Position: Nicholas J. Fortuin Professor of Cardiology, Division of Cardiology, The Johns Hopkins University School of Medicine. Professor of Medicine, Department of Medicine, Division of Cardiology, The Johns Hopkins University School of Medicine. Professor of Pediatrics, Department of Pediatrics, Division of Pediatric Cardiology, The Johns Hopkins University School of Medicine. Director of the Arrhythmia Service,

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Clinical Electrophysiology Laboratory, and Arrhythmogenic Right Ventricular Dysplasia Program, The Johns Hopkins Hospital

Vivek Reddy, MD Address: Mt. Sinai Heart, One Gustave L Levy Place, Box 1030, New York, NY 10029 Telephone: 212-241-7114 Fax: 646-537-9691

Coordinating Investigators

Professional Position: The Leona M. and Harry B. Helmsley Charitable Trust Professor of Medicine in Cardiac Electrophysiology Robert Kowal, MD Address: Cardiology Consultants of Texas, 621 North Hall Street, Suite 4400, Dallas, TX 75226 Telephone: 469-800-7400 Fax: 469-800-7410

Professional Position: Co-Medical Director, Cardiac Electrophysiology Baylor Scott and White Health Care VP and Medical Director, Best Care and Clinical Integration Baylor Scott and White Quality Alliance

Wilbur Su, MD Address: Banner-University Medical Group-Heart Center 1300 North 12th Street, Suite 407, Phoenix, AZ 58006 Telephone: 602-839-7393

Professional Position: Clinical Assoc. Professor of Medicine, University of Arizona, Chief of Cardiac EP, Banner-University Medical Center-Phoenix, Director of EP Fellowship, Banner-University Medical CenterPhoenix

Confidentiality Statement

The information contained in this document is confidential and the proprietary property of Medtronic. Any distribution, copying, or disclosure without the prior written authorization of Medtronic is strictly prohibited. Persons to whom the information is disclosed must know that it is confidential and that it may not be further

disclosed by them.

Version 4, 10NOVO016

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056-F275, Clinical Investigation Plan Template, Version 2.0

1. Version History

Page 3 of 115

Version 1.0 2.0

2.0

2.0

Summary of Changes

Rationale

Author(s)/Title

Not Applicable, New Document

Not Applicable, New Document Dana Wigert, Sr. Prin. Clinical Research Specialist

Fred Kueffer, Pr. Statistician

Synopsis, Sections 7.1, 7.2 and 18: Modified the primary efficacy OPC and changed the atypical flutter treatment failure to any recurrence of atrial flutter

FDA feedback

Dana Wigert, Sr. Prin. Clinical Research Specialist

Fred Kueffer, Pr. Statistician

Synopsis, Sections 7.1, 7.2 14.16 and 18.3.2: Changed the secondary safety objective to a primary safety objective with a pre-specified hypothesis

FDA feedback

Dana Wigert, Sr. Prin. Clinical Research Specialist

Fred Kueffer, Pr. Statistician

Synopsis, Sections 7.1, 7.2 and 18.5: Added an ancillary objective

Dana Wigert, Sr. Prin. Clinical Research Specialist

Fred Kueffer, Pr. Statistician

2.0

Synopsis, Sections 7.1, 7.2

and 18.5: Added and

ancillary objective

Dana Wigert, Sr. Prin. Clinical Research Specialist

Fred Kueffer, Pr. Statistician

2.0

Synopsis, Sections 7.1, 7.2

and 18.5: Removed

objective

ancillary

Dana Wigert, Sr. Prin. Clinical Research Specialist

Fred Kueffer, Pr. Statistician

2.0

Synopsis, Sections 5, 8

Participation and enrollment in Dana Wigert, Sr. Prin. Clinical

and 18: Study data from Japan is anticipated to start

Research Specialist

the Japanese centers will later than the other

not be included in the

geographies

Fred Kueffer, Pr. Statistician

PMA-S submission, but will

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be included in a submission to Japan Pharmaceuticals and Medical Device Agency (PMDA)

2.0

Table 5: Noted the

Clarification

complication definition

may vary from study to

study

Dana Wigert, Sr. Prin. Clinical Research Specialist

Fred Kueffer, Pr. Statistician

2.0

Sections 14 and 20.2:

FDA feedback and consistent Dana Wigert, Sr. Prin. Clinical

Added weekly and

with the 2012 HRS Expert

Research Specialist

symptom driven event monitoring

Consensus Statement on Catheter and Surgical Ablation

Fred Kueffer, Pr. Statistician

of AF

2.0

Sections 7.2.1, 14.7 and FDA feedback

18.3: Modified the

antiarrhythmic dose

allowed after the blanking

period to historic

maximum

Dana Wigert, Sr. Prin. Clinical Research Specialist

Fred Kueffer, Pr. Statistician

2.0

Sections 7.2.1 and 18: 12- Aligns with standard practice Dana Wigert, Sr. Prin. Clinical

lead ECGs need to

and FDA feedback

Research Specialist

demonstrate at least 10 seconds of an atrial

Fred Kueffer, Pr. Statistician

arrhythmia to be

considered a treatment

failure

2.0

Section 8.2: Rationale was Consistent with the addition of Dana Wigert, Sr. Prin. Clinical

updated

a primary safety objective

Research Specialist

Fred Kueffer, Pr. Statistician

2.0

Section 14.1: Added

Clarification

review of symptoms

suggestive of recurrent

AF/AT/AFL to the study

procedures and data

collection table

Dana Wigert, Sr. Prin. Clinical Research Specialist

Fred Kueffer, Pr. Statistician

2.0

Section 14.4: Added When Clarification

performed, the TEE should

be occur within 1 day (on

the day of or within the day

prior to) the planned

ablation procedure

Dana Wigert, Sr. Prin. Clinical Research Specialist

Fred Kueffer, Pr. Statistician

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056-F275, Clinical Investigation Plan Template, Version 2.0

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2.0

Section 14.5.5: Require

FDA feedback

CTI ablation if typical

flutter has been

documented or was

induced. Recommend

induction if not in the

documented history.

Dana Wigert, Sr. Prin. Clinical Research Specialist

Fred Kueffer, Pr. Statistician

2.0

Sections 7.2.1, 7.2.3,

Allows for treatment of pre- Dana Wigert, Sr. Prin. Clinical

14.5.5, 14.8, 18.3, and

existing right atrial arrhythmias Research Specialist

18.5: removed the limitation that only CTI

that may contribute to the primary objective if left

Fred Kueffer, Pr. Statistician

ablations are allowed in the untreated

right atrium

2.0

Section 14.18: Added that Compliance percentage will be Dana Wigert, Sr. Prin. Clinical

a study deviation is not

managed by the core lab

Research Specialist

required if a subject misses a weekly TTM

Fred Kueffer, Pr. Statistician

transmission.

2.0

Section 17: Added that

To support adverse event

Dana Wigert, Sr. Prin. Clinical

associated imaging

adjudication

Research Specialist

studies may be requested, if available, for all serious

Fred Kueffer, Pr. Statistician

adverse events with

possible relatedness to

the system or procedure

2.0

Section 18: Provided

FDA feedback

details regarding the

determination of subjects

for data analysis

Dana Wigert, Sr. Prin. Clinical Research Specialist

Fred Kueffer, Pr. Statistician

2.0

Section 18.4: Provided

FDA feedback

details on the Hommel

stepwise procedure for

the secondary objectives

Dana Wigert, Sr. Prin. Clinical Research Specialist

Fred Kueffer, Pr. Statistician

2.0

Section 18.5: Stated that FDA feedback

ancillary objectives been

defined to provide

additional information

about the performance of

the Arctic Front Advance

Cardiac CryoAblation

Catheter. No hypotheses

are defined for regulatory

or labeling purposes.

Dana Wigert, Sr. Prin. Clinical Research Specialist

Fred Kueffer, Pr. Statistician

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