Assessment of the Safety and Performance of the HARPOON™ Beating Heart Mitral Valve Repair System; a Multi-center Post-market Study (ASCEND)
- Conditions
- Severe Degenerative Mitral Regurgitation due to Mid-segment Posterior Leaflet Prolapse
- Registration Number
- DRKS00022786
- Lead Sponsor
- Harpoon Medical, an indirect-wholly owned subsidiary of Edwards Lifesciences Corporation, Edwards Lifesciences,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 42
1. Subject is = 18 years old
2. Presence of severe MR as read on a transthoracic echocardiographic study
3. 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
4. Degenerative mitral valve disease with mid-segment P2 prolapse
5. 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
1. Patient is of the age where further growth is expected
2. Active endocarditis
3. Left ventricular or left atrial appendage thrombus
4. Severe mitral annular and/or leaflet calcification
5. Cannot tolerate procedural anticoagulation or post-procedure antiplatelet regimen
6. Mitral stenosis
7. Functional Mitral Valve disease
8. Previous mitral valve replacement surgery
9. Fragile or thinning apex
10. Contraindications to transoesophageal echocardiography (atlantoaxial disease, severe generalized cervical arthritis, upper gastrointestinal bleeding, significant dysphagia and odynophagia, has received extensive radiation to the mediastinum)
11. Patient is pregnant or lactating
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - freedom from all-cause mortality, disabling stroke and life- threaten-ing bleeding at 30 days post-implant.<br>- procedure success at 30 days post-treatment, as measured by: Tech-nical success with reduction of MR to less than or equal to mild and the absence of major device or procedure-related SAEs.<br>
- Secondary Outcome Measures
Name Time Method - Technical success defined as survival and exit from the operating room (OR) with successful implantation of 3 or more ePTFE chords.<br> - Freedom from major device or procedure-related serious adverse event (SAE) at 30 days, 1 year and 2 years post-implant.<br> - Freedom from ePTFE chord rupture as reported by echo core lab at 1 year and 2 years post-implant.<br> - Freedom from reoperation or re-intervention due to ePTFE chord rupture at 1 year and 2 years post-implant.<br> - Freedom from reoperation or reintervention on the mitral valve annually through 5 years post-implant<br> - Freedom from >/= moderate MR annually through 5 years post-implant<br> - Functional improvement from baseline NYHA Functional Classification at 1 year and 2 years post-implant<br> - Quality of Life (change from Baseline to 1 and 6 months)<br> - 6 minute walk test (change from Baseline to 1 and 6 months) <br>