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Safety and Performance Study of the Harpoon Mitral Valve Repair System

Primary Purpose

Mitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency

Status

Terminated

Phase

Not Applicable

Locations

Poland

Study Type

Interventional

Intervention

Harpoon Artificial ePTFE Chords

About this trial

This is an interventional treatment trial for Mitral Valve Regurgitation focused on measuring Mitral Valve Repair, Transapical, artificial chordae, bi-leaflet prolapse, anterior prolapse, posterior prolapse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 18 years
Patient referred for mitral valve surgery
Presence of severe MR as read on an echocardiographic study performed within 60 days prior to procedure.
Estimated post-ePTFE cordal implantation coaptation surface is adequate in the judgment of the operating surgeon and the patient eligibility committee
Degenerative mitral valve disease associated with anterior, bileaflet, or posterior leaflet prolapse
Patient is able to sign informed consent and able to return for follow-up and is capable of participating in all testing associated with this clinical investigation
Women of child-bearing potential have a negative pregnancy test

Exclusion Criteria:

Age < 18 years
Infective endocarditis
History of Mediastinal Radiation
Inflammatory (rheumatic) valve disease
Requirement for concomitant cardiac surgery (e.g., coronary artery bypass grafting (CABG), aortic valve surgery, etc.)
Symptomatic coronary artery disease
Cardiogenic shock at the time of enrollment
ST segment elevation myocardial infarction requiring intervention within 30 days prior to enrollment
Evidence of cirrhosis or hepatic synthetic failure
Pregnancy at the time of enrollment (women of child bearing age should have negative pregnancy within 14 days of surgery)
Severe pulmonary hypertension (PA systolic pressure > 70 mmHg)
Previous cardiac surgery, or surgery on the left pleural space
Left ventricular, atrial or appendage thrombus
Severely calcified mitral leaflets
Recent stroke (< 6 months) with permanent impairment
EuroScore (for mitral valve repair) > 8%
Patients with contraindications to Transesophageal echocardiography
Severe left or right ventricular dysfunction
NYHA Class IV
Renal insufficiency CKD stage 3b or worse (GFR < 45 ml/min/1.73 m2)
Patient is participating in another clinical study for which follow-up is currently ongoing. (Co-enrollment in an investigational device or interventional study)
Patient with non-cardiac co-morbidities and life expectancy < 1 year
Patient has a condition or conditions that, in the opinion of the Investigator, preclude participation, including willingness to comply with all follow-up procedures

Sites / Locations

Jagiellonian University
Instytut of Kardiologii & Transplantology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Harpoon Medical Transapical device TSD-5

Arm Description

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

Outcomes

Primary Outcome Measures

Number of Subjects With Procedural Success During the First 30 Days

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.

Number of Subjects With Freedom From Serious Adverse Events (SAE) During the First 30 Days

Procedure freedom from Serious Adverse Events (SAEs) during the procedure, at discharge, and at 30 days follow-up shall be tracked and recorded.

Secondary Outcome Measures

Subject's Severity of Mitral Regurgitation Over Time

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

Subject's Freedom From Serious Adverse Events Over Time

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

Full Information

NCT ID

NCT03285724

First Posted

September 14, 2017

Last Updated

November 5, 2019

Sponsor

Edwards Lifesciences

1. Study Identification

Unique Protocol Identification Number

NCT03285724

Brief Title

Safety and Performance Study of the Harpoon Mitral Valve Repair System

Official Title

Safety and Performance Study of the Harpoon Medical Device in Patients With Degenerative Mitral Regurgitation

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Terminated

Why Stopped

Edwards Lifesciences acquired Harpoon Medical in December 2017 and a decision has been made to close enrollment in the HMEFS-2000 protocol

Study Start Date

May 16, 2017 (Actual)

Primary Completion Date

June 16, 2017 (Actual)

Study Completion Date

April 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Edwards Lifesciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

The primary objective of this study is to evaluate the safety and performance of the Harpoon Medical Device. It is anticipated, that the Harpoon Medical Device will provide advantages over current surgical interventions including: 1) a small minimally invasive incision, 2) no sternotomy, 3) no cardiopulmonary bypass, 4) no aortic manipulation, 5) a direct path to the valve plane, 6) performed on a beating heart, 7) real-time TEE-guided ePTFE cordal length adjustment and 8) less complicated procedure that is teachable and adoptable.

Detailed Description

The device is designed to reduce the degree of mitral regurgitation by delivering and anchoring artificial chordae tendineae to the affected mitral valve leaflet(s) in a beating heart.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency

Keywords

Mitral Valve Repair, Transapical, artificial chordae, bi-leaflet prolapse, anterior prolapse, posterior prolapse

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Harpoon Medical Transapical device TSD-5

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Harpoon Artificial ePTFE Chords

Intervention Description

The Harpoon Medical Transapical device is intended to be used to reduce the degree of degenerative mitral regurgitation by delivering and anchoring one or more ePTFE cords to the affected mitral valve leaflet(s) via a small left thoracotomy on the beating heart in patients with anterior, bi-leaflet or posterior prolapse.

Primary Outcome Measure Information:

Title

Number of Subjects With Procedural Success During the First 30 Days

Description

Time Frame

Procedure, discharge, and 30 days

Title

Number of Subjects With Freedom From Serious Adverse Events (SAE) During the First 30 Days

Description

Procedure freedom from Serious Adverse Events (SAEs) during the procedure, at discharge, and at 30 days follow-up shall be tracked and recorded.

Time Frame

Procedure, Discharge and 30 Days

Secondary Outcome Measure Information:

Title

Subject's Severity of Mitral Regurgitation Over Time

Description

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

Time Frame

6 Months, 12 Months, and 24 Months

Title

Subject's Freedom From Serious Adverse Events Over Time

Description

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

Time Frame

6 Months, 12 Months, and 24 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 18 years Patient referred for mitral valve surgery Presence of severe MR as read on an echocardiographic study performed within 60 days prior to procedure. Estimated post-ePTFE cordal implantation coaptation surface is adequate in the judgment of the operating surgeon and the patient eligibility committee Degenerative mitral valve disease associated with anterior, bileaflet, or posterior leaflet prolapse Patient is able to sign informed consent and able to return for follow-up and is capable of participating in all testing associated with this clinical investigation Women of child-bearing potential have a negative pregnancy test Exclusion Criteria: Age < 18 years Infective endocarditis History of Mediastinal Radiation Inflammatory (rheumatic) valve disease Requirement for concomitant cardiac surgery (e.g., coronary artery bypass grafting (CABG), aortic valve surgery, etc.) Symptomatic coronary artery disease Cardiogenic shock at the time of enrollment ST segment elevation myocardial infarction requiring intervention within 30 days prior to enrollment Evidence of cirrhosis or hepatic synthetic failure Pregnancy at the time of enrollment (women of child bearing age should have negative pregnancy within 14 days of surgery) Severe pulmonary hypertension (PA systolic pressure > 70 mmHg) Previous cardiac surgery, or surgery on the left pleural space Left ventricular, atrial or appendage thrombus Severely calcified mitral leaflets Recent stroke (< 6 months) with permanent impairment EuroScore (for mitral valve repair) > 8% Patients with contraindications to Transesophageal echocardiography Severe left or right ventricular dysfunction NYHA Class IV Renal insufficiency CKD stage 3b or worse (GFR < 45 ml/min/1.73 m2) Patient is participating in another clinical study for which follow-up is currently ongoing. (Co-enrollment in an investigational device or interventional study) Patient with non-cardiac co-morbidities and life expectancy < 1 year Patient has a condition or conditions that, in the opinion of the Investigator, preclude participation, including willingness to comply with all follow-up procedures

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Krzysztof Bartus, MD PhD

Organizational Affiliation

Jagiellonian University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jagiellonian University

City

Krakow

Country

Poland

Facility Name

Instytut of Kardiologii & Transplantology

City

Warsaw

ZIP/Postal Code

04-628

Country

Poland

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Safety and Performance Study of the Harpoon Mitral Valve Repair System

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