Safety and Performance Study of the Harpoon Mitral Valve Repair System

Study Overview
=================
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.

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

Conditions
-----------------
Mitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency

Intervention / Treatment
-----------------
* Device: Harpoon Artificial ePTFE Chords


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Harpoon Medical Transapical device TSD-5<br>This is a prospective, single arm, nonrandomized, early feasibility study to evaluate the safety and performance of the Harpoon Medical Device. | Device: Harpoon Artificial ePTFE Chords<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Procedure, discharge, and 30 days | 
| 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. | Procedure, Discharge and 30 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 Months, 12 Months, and 24 Months | 
| 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 | 6 Months, 12 Months, and 24 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mitral Valve Repair, Transapical, artificial chordae, bi-leaflet prolapse, anterior prolapse, posterior prolapse