CE Mark Study for the Harpoon Medical Device in Poland

Study Overview
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Brief Summary
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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
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The TSD-5 is intended to secure ePTFE sutures on the mitral valve for the treatment of mitral valve disease.

Official Title
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Safety and Performance Study of the Harpoon Medical Transapical Suturing Device (TSD-5) in Subjects With Degenerative Mitral Regurgitation - CE Mark Study for the Harpoon Medical Device in Poland

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

Intervention / Treatment
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* Device: Harpoon Medical Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Harpoon Medical TSD-5<br>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. | Device: Harpoon Medical Device<br>* It is expected that the Harpoon Medical transapical suturing device will be a valuable treatment alternative for patients suffering from mitral valve regurgitation because it can access the left ventricle with a small shaft or via a small valved introducer with a secure anchoring mechanism that can be deployed anywhere on the mitral valve leaflet.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject's Procedural Success During the First 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. | Procedure and 30 days | 
| Percentage of Subject's With Freedom From Serious Adverse Events (SAE) </= 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. | Procedure and 30 days | 
| Subject's Serious Adverse Events (SAE) Through Discharge | Number of Participants experiencing a Serious Adverse Event (SAE) through time of Discharge. | Discharge, an average of 6 days post implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject's Severity of Mitral Regurgitation Over Time | 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. | 6 months, 12 months, 18 months, and 24 months | 
| Percentage of Subject's With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Subject's freedom from Serious Adverse Events at >30 days post-implant. Time to events were estimated by Kaplan-Meier method. | 6 months, 12 months, 18 months, 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mitral Valve Repair, Transapical, artificial chordae