Safety and Performance Study of the Harpoon Mitral Valve Repair System

Not Applicable

Terminated

Conditions: Mitral Valve Insufficiency
Mitral Valve Regurgitation
Mitral Valve Prolapse

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Harpoon Medical Transapical device TSD-5	Harpoon Artificial ePTFE Chords	This is a prospective, single arm, nonrandomized, early feasibility study to evaluate the safety and performance of the Harpoon Medical Device.

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Procedural Success During the First 30 Days	Procedure, discharge, and 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, Discharge and 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

Name	Time	Method
Subject's Severity of Mitral Regurgitation Over Time	6 Months, 12 Months, and 24 Months	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	6 Months, 12 Months, and 24 Months	Freedom from Serious Adverse Events (SAEs) at 6 months, 12 months and 24 months follow-up shall be tracked and recorded