056-F275, Clinical Investigation Plan Template, Version 2.0 Page 1 of 115
056-F275, Clinical Investigation Plan Template, Version 2.0
Page 1 of 115
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,
Version 4, 10NOV2016
Confidential
056-F275, Clinical Investigation Plan Template, Version 2.0
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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
Confidential
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
Version 4, 10NOVO016
Confidential
056-F275, Clinical Investigation Plan Template, Version 2.0
Page 4 of 115
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
Version 4, 10NOVO016
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056-F275, Clinical Investigation Plan Template, Version 2.0
Page 5 of 115
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
Version 4, 10NOVO016
Confidential
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