Clinical trials: Mitral Valve Repair
Functional Mitral Regurgitation, Mitral Regurgitation
Edwards Cardioband System ACTIVE Pivotal Clinical Trial (ACTIVE)
To establish the safety and effectiveness of the Edwards Cardioband System in patients with functional mitral regurgitation (FMR).
- Conditions
- Functional Mitral Regurgitation, Mitral Regurgitation, Mitral Insufficiency
- Trial name
- ACTIVE (NCT03016975)
- Testing
- Edwards Cardioband System, Guideline Directed Medical Therapy
- Where
- 24 sites in United States
- Volunteers
- 12 people
- Sponsor
- Edwards Lifesciences
Mitral Valve Insufficiency, Heart Valve Diseases
NeoChord TACT Post-Market Surveillance Registry
To monitor the long-term performance of the CE Marked NeoChord Artificial Chordae Delivery System
- Conditions
- Mitral Valve Insufficiency, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases
- Trial name
- NCT01784055
- Where
- 7 sites in France, Germany and 3 more
- Volunteers
- 126 people
- Sponsor
- NeoChord
Severe Degenerative Mitral Regurgitation Due to Mid-segment Posterior Leaflet Prolapse
Observational Registry on the HARPOON Device
To collect data on the HARPOON™ Mitral Valve Repair System for use in patients with severe degenerative mitral regurgitation due to posterior leaflet prolapse.
- Trial name
- REPLICATE (NCT04393779)
- Testing
- HARPOON Beating Heart Mitral Valve Repair System (MVRS)
- Where
- 7 sites in Germany, Spain and 1 more
- Volunteers
- 26 people
- Sponsor
- Edwards Lifesciences
Mitral Valve Insufficiency, Heart Failure
Carillon Mitral Contour System® for Reducing Functional Mitral Regurgitation
The objective of this prospective, multi-center, randomized, double-blind trial is to assess the safety and efficacy of the Carillon Mitral Contour System in treating functional mitral regurgitation (FMR) associated with heart…
- Trial name
- REDUCE FMR (NCT02325830)
- Testing
- Carillon Mitral Contour System
- Where
- 31 sites in Australia, Czechia and 6 more
- Volunteers
- 163 people
- Sponsor
- Cardiac Dimensions Pty Ltd
Mitral Valve Regurgitation, Mitral Valve Prolapse
CE Mark Study for the Harpoon Medical Device in Poland
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…
- Conditions
- Mitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency
- Trial name
- NCT02432196
- Testing
- Harpoon Medical Device
- Where
- 2 sites in Poland
- Volunteers
- 26 people
- Sponsor
- Edwards Lifesciences
Mitral Valve Insufficiency, Heart Failure
Effectiveness of Surgical Mitral Valve Repair Versus Medical Treatment for People With Significant Mitral Regurgitation and Non-ischemic Congestive Heart Failure
Mitral regurgitation (MR), also known as mitral insufficiency, is a condition in which the heart's mitral valve, located between two of the heart's main chambers, does not firmly shut, allowing blood to leak backwards within the…
- Trial name
- SMMART-HF (NCT00608140)
- Testing
- Surgical mitral valvuloplasty with placement of annular ring (SMVR), Optimal medical therapy (OMT)
- Where
- 9 sites in United States, Canada
- Volunteers
- 2 people
- Sponsor
- Duke University
Mild Tricuspid Regurgitation, Moderate Tricuspid Regurgitation
Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery
The purpose of the research is to determine whether repairing a tricuspid valve (TV) in patients with mild to moderate tricuspid regurgitation (TR), at the time of planned mitral valve surgery (MVS), would improve the heart…
- Conditions
- Mild Tricuspid Regurgitation, Moderate Tricuspid Regurgitation, Tricuspid Regurgitation
- Trial name
- NCT02675244
- Testing
- TV Annuloplasty, MVS
- Where
- 41 sites in United States, Canada and 1 more
- Volunteers
- 401 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Mitral Valve Insufficiency, Mitral Valve Regurgitation
EVEREST II Pivotal Study High Risk Registry (HRR)
Prospective, multi-center, single arm registry. Clinical follow-up at discharge, 30 days, 6, 12, 18 and 24, months, and 3, 4 and 5 years.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation
- Trial name
- HRR (NCT01940120)
- Testing
- Percutaneous mitral valve repair using MitraClip implant
- Where
- 2 sites in United States
- Volunteers
- 78 people
- Sponsor
- Abbott Medical Devices
Mitral Valve Regurgitation, Mitral Valve Prolapse
Safety and Performance Study of the Harpoon Mitral Valve Repair System
The primary objective of this study is to evaluate the safety and performance of the Harpoon Medical Device. It is anticipated, that the Harpoon Medical Device will provide advantages over current surgical interventions…
- Conditions
- Mitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency
- Trial name
- NCT03285724
- Testing
- Harpoon Artificial ePTFE Chords
- Where
- 2 sites in Poland
- Volunteers
- 1 people
- Sponsor
- Edwards Lifesciences