Safety and Early Feasibility Study of the Harpoon Medical Device (EFS)

Not Applicable

Completed

Conditions: Mitral Valve Prolapse
Mitral Valve Regurgitation
Mitral Valve Insufficiency

Interventions: Device: Harpoon Medical Device

Registration Number: NCT02771275

Lead Sponsor: Edwards Lifesciences

Brief Summary: The purpose of this study is to evaluate the safety and performance of the Harpoon Medical TSD-5. The Harpoon device will provide many significant 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 chordal length adjustment and 8) less complicated procedure that is teachable and adoptable.

Detailed Description: The TSD-5 is intended to secure ePTFE sutures on the mitral valve for the treatment of mitral valve disease.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 13

Inclusion Criteria

All subjects referred for mitral valve surgery
Presence of severe mitral regurgitation as read on an echocardiographic study performed within 60 days prior to procedure. Assessment of mitral regurgitation will be performed by the investigational site echocardiography laboratory and confirmed by the Core Echocardiography Laboratory using an integrative method.
Age > 18 years
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
Subject 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
Able to sign informed consent

Exclusion Criteria

Age < 18 years
Infective endocarditis
Anterior or bileaflet prolapse
Functional mitral regurgitation
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%
Subjects 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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Harpoon Medical Device TSD-5	Harpoon Medical Device	This is a prospective, nonrandomized, single-centered European study designed single arm study to demonstrate the performance and safety of the Harpoon Medical TSD-5 in Subjects with degenerative mitral regurgitation.

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Procedural Success During the First 30 Days	Procedure through 30 days	Procedural success was defined as the patient leaving the operating room with a successful implant of one or more ePTFE cords on the mitral valve and reduced mitral regurgitation from severe to \</=moderate at the conclusion of the procedure and at 30 days post-procedure.
Percentage of Subject's With Freedom From Serious Adverse Events (SAE) </= 30 Days	Procedure through 30 days	Subject's freedom from Serious Adverse Events during the ePTFE implantation procedure and at 30 days follow-up. Time to events were estimated by Kaplan-Meier method.
Subject's Serious Adverse Events (SAE) Through Discharge	Discharge, an average of 8 days post implantation	Number of Participants experiencing a Serious Adverse Event (SAE) through time of Discharge.

Secondary Outcome Measures

Name	Time	Method
Percentage of Subject's With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days	6 months, 12 months, 18 months, 24 months, 30 months, and 36 months	Subject's freedom from Serious Adverse Events at \>30 days post-implant. Time to events were estimated by Kaplan-Meier method.
Subject's Severity of Mitral Regurgitation Over Time	6 months, 12 months, 18 months, 24 months, 30 months, and 36 months	Valvular regurgitation occurs when the valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation. The numbers on the scale are reflected as follows: 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome.