Treatment of Mitral Regurgitation Using a Minimally Invasive Approach With the HARPOON Device.

Study Overview
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Brief Summary
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To evaluate the long-term safety and performance of the HARPOON™ MVRS for use in patients presenting with severe degenerative mitral regurgitation due to posterior leaflet prolapse in the post-market phase.

Detailed Description
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This trial is a single arm, prospective, multi-center, non-randomized and open-label post-market study that will evaluate subjects for up to 5 years post treatment.

Official Title
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Assessment of the Safety and Performance of the HARPOON™ Beating Heart Mitral Valve Repair System; a Multi-center Post-market Study (ASCEND)

Conditions
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Mitral Regurgitation

Intervention / Treatment
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* Device: HARPOON Beating Heart Mitral Valve Repair System (MVRS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is > 18 years old Presence of severe MR as read on a transthoracic echocardiographic study Mitral leaflet coaptation surface is sufficient to reduce mitral regurgitation without undue leaflet tension (approximate leaflet to gap ratio of 2:1) based on the judgment of the patient eligibility committee and the operating surgeon Degenerative mitral valve disease with mid-segment P2 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 Exclusion Criteria: Patient is of the age where further growth is expected Active endocarditis Left ventricular or left atrial appendage thrombus Severe mitral annular and/or leaflet calcification Cannot tolerate procedural anticoagulation or post-procedure antiplatelet regimen Mitral stenosis Functional Mitral Valve disease Previous mitral valve replacement surgery Fragile or thinning apex Contraindications to transoesophageal echocardiography (atlantoaxial disease, severe generalized cervical arthritis, upper gastrointestinal bleeding, significant dysphagia and odynophagia, has received extensive radiation to the mediastinum) Patient is pregnant or lactating

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 |
| --- | --- |
| Other: HARPOON MVRS<br>Subjects who were treated with the HARPOON MVRS. | Device: HARPOON Beating Heart Mitral Valve Repair System (MVRS)<br>* Repair of the chordae tendinae in the mitral valve.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subject's With Freedom From All-cause Mortality, Disabling Stroke and Life-threatening Bleeding | Subject's freedom from all-cause mortality, disabling stroke and life-threatening bleeding at 30 days post-implant. | 30 days | 
| Number of Subjects With Procedural Success During the First 30 Days | Subject's procedural success at 30 days post-treatment, as measured by: Technical success (defined as implantation of at least three chords, leaving the operating room and no conversion to open heart surgery) with reduction of MR to less than or equal to mild and the absence of major device or procedure-related SAEs. | 30 days |