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

 Exclusion Criteria:

 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