Assessment of the safety and performance of the HARPOON* Beating Heart Mitral Valve Repair System; a multi-center post-market study (The ASCEND Study).
- Conditions
- mitral regurgitation or leaking10046973
- Registration Number
- NL-OMON50870
- Lead Sponsor
- HARPOON Medical, an indirect wholly-owned subsidiary of Edwards Lifesciences Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
Each subject is required to meet all of the following inclusion criteria:
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
A subject meeting any of the following criteria shall be excluded:
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 non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Safety Endpoint:<br /><br>Freedom from all-cause mortality, disabling stroke and life- threatening<br /><br>bleeding at 30 days post-implant.<br /><br><br /><br>Primary Performance Endpoint:<br /><br>Procedure success at 30 days post-treatment, as measured by: Technical success<br /><br>with reduction of MR to less than or equal to mild and the absence of major<br /><br>device or procedure-related SAEs. </p><br>
- Secondary Outcome Measures
Name Time Method