Safety and Performance Study of the Harpoon Mitral Valve ...

Safety and Performance Study of the Harpoon Mitral Valve Repair System NCT03285724 October 12, 2016

Edwards Lifesciences LLC One Edwards Way Irvine, CA USA 92614 Phone: 949.250.2500 Fax: 949.250.2525

Protocol Title: Protocol Number: Version: Sponsor:

Safety and Performance study of the Harpoon Medical Device in patients with degenerative mitral regurgitation HMEFS -2000 00a dated 12Oct2016

Monitor:

European Authorized Representative:

CONFIDENTIALITY STATEMENT

This study is confidential in nature. All information related to this study is considered proprietary and should not be made available to those not directly involved in this study. Authorized recipients of this information include investigators and co-investigators, other health care personnel necessary to conduct the study and Ethical Committees

The above personnel provided with data from this study are hereby informed of its confidential and proprietary nature. Release of this data to individuals other than those listed above requires the prior written permission of Sponsor.

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Contents

I. PRIMARY CONTACTS .........................................................................................................3 II. STUDY SUMMARY...............................................................................................................4 III. BACKGROUND AND RATIONALE .......................................................................................7

DEVICE DESCRIPTION ..................................................................................................... 8 SUMMARY OF PRECLINICAL STUDIES ........................................................................... 9 POTENTIAL BENEFITS.....................................................................................................10 POTENTIAL RISKS ...........................................................................................................10 MINIMIZATION OF RISKS.................................................................................................12 OPERATOR TRAINING AND EXPERIENCE.....................................................................12 IV. STUDY OBJECTIVES.........................................................................................................13 Endpoints ...........................................................................................................................13 V. STUDY DESIGN .................................................................................................................13 VI. STUDY POPULATION ........................................................................................................13 NUMBER OF PATIENTS ...................................................................................................13 INTENDED USE ................................................................................................................14 INCLUSION CRITERIA ......................................................................................................14 EXCLUSION CRITERIA.....................................................................................................14 VII. PATIENT ENROLLMENT....................................................................................................15 PRE SCREENING .............................................................................................................15 TREATMENT PROCEDURE/ASSESSMENTS ..................................................................16 FOLLOW-UP PROCEDURES/ASSESSMENTS ................................................................17 UNSCHEDULED FOLLOW UP VISITS..............................................................................20 PATIENT WITHDRAWAL FROM THE STUDY ..................................................................20 END OF PARTICIPATION .................................................................................................20 DURATION OF INVESTIGATION ......................................................................................20 VIII. SAFETY MANAGEMENT ...............................................................................................21 DEFINITIONS ...........................................................................................................................21 EVENT SEVERITY ............................................................................................................22 CAUSALITY RELATIONSHIP ...................................................................................................22 INVESTIGATOR REPORTING RESPONSIBILITIES ................................................................23 REPORTING TO EC/CA ....................................................................................................24 IX. INVESTIGATIONAL DEVICEDISTRIBUTION AND ACCOUNTABILITY .............................24 X. STATISTICAL ANALYSIS ...................................................................................................25 XI. STUDY ORGANISATION....................................................................................................25 INVESTIGATIONAL SITE PERSONNEL ...........................................................................25 CLINICAL MONITORING...................................................................................................26 CLINCAL EVENTS COMMITTEE ......................................................................................27 STUDY ADMINISTRATION ...............................................................................................27 REGULATORY CONSIDERATIONS: RECORDS RETENTION POLICY...........................29 DATA QUALITY ASSURANCE ..........................................................................................29 STATEMENT OF INSURANCE POLICY............................................................................30 XII. ETHICAL CONSIDERATIONS ............................................................................................30 DECLARATION OF HELSINKI...........................................................................................30 PATIENT INFORMATION AND INFORMED CONSENT....................................................30 PATIENT CONFIDENTIALITY ...........................................................................................30 ETHICS COMMITTEE .......................................................................................................31 REGULATORY APPROVAL ..............................................................................................31 XIII. QUALIFICATIONS OF STUDY CENTERS AND INVESTIGATORS...............................31 XIV. PUBLICATION POLICY .................................................................................................31

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XV.REFERENCES....................................................................................................................33

I. PRIMARY CONTACTS

Sponsor:

Monitor:

European Authorized Representative:

Principal Investigator(s)

(Protocol Signature pages are provided separate to this protocol)

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II. STUDY SUMMARY Title: Protocol Number: Design:

Study Duration: Primary Objective: Patient Population: Sample Size: Number of Sites: Treatments:

Endpoints:

Safety and Performance study of the Harpoon Medical Device in patients with degenerative mitral regurgitation

HMEFS-2000 Ver 00a

This is a prospective, single arm, nonrandomized, early feasibility study to evaluate the safety and performance of the Harpoon Medical Device.

Projected enrollment of first patient December 2016 Projected exit of final patient: December 2019

The primary objective of this study is to evaluate the safety and performance of the Harpoon Medical Device.

Patients with "Severe" mitral regurgitation as a result of posterior, bileaflet or anterior prolapse.

Up to twenty (20) patients in PL will be enrolled.

Krakow will be the only center participating in this study.

Up to eight (8) pairs of ePTFE cords may be placed in the anterior and/or posterior mitral valve using the Harpoon Medical Device in order to establish effective coaptation of the mitral leaflets.

Primary Performance Endpoints: To demonstrate that the Harpoon Medical Device performs as designed and can successfully implant one or more ePTFE artificial cords on either the anterior, posterior, or both leaflets of the mitral valve via a small left thoracotomy on the beating heart and reduce mitral regurgitation from "severe" to less than or equal to "moderate" at the conclusion of the procedure and at 30 days post-procedure.

Secondary Performance Endpoints: Severity of mitral regurgitation at 6 months, 12 months and 24 months follow-up shall be tracked and recorded

Primary Safety Endpoints: Procedure freedom from Serious Adverse Events (SAEs) during the procedure, at discharge, and at 30 days follow-up shall be tracked and recorded. Rates are expected to be not significantly worse than conventional mitral valve surgery.

Secondary Safety Endpoints Freedom from Serious Adverse Events (SAEs) at 6 months, 12 months and 24 months follow-up shall be tracked and recorded

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