Below are current clinical trials.1 studies in Mitral valve regurgitation
(open studies only).
Filter this list of studies by location, status and more.
Cardiovascular Outcomes Assessment of the MitraClip Therapy Percutaneous Therapy for High Surgical Risk Patients
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: III What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
About this study
The purpose of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) Trial is to confirm the safety and effectiveness of the MitraClip System for the treatment of moderate-to-severe or severe functional mitral regurgitation (FMR) in Symptomatic Heart Failure Subjects.
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
Print study details
- Rochester, Minnesota: 12-006984
NCT ID: NCT01626079
Sponsor Protocol Number: 11-512
March 22, 2016
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- What is pulmonary hypertension? National Heart, Lung, and Blood Institute. http://www.nhlbi.nih.gov/health/health-topics/topics/pah/. Accessed Dec. 9, 2014.
- Gaasch WH. Overview of the management of chronic mitral regurgitation. http://www.uptodate.com/home. Accessed Dec. 8, 2014.
- Schiller NB, et al. Echocardiographic evaluation of the mitral valve. http://www.uptodate.com/home. Accessed Dec. 8, 2014.
- Maganti K, et al. Valvular heart disease: Diagnosis and management. Mayo Clinic Proceedings. 2010;85:483.
- Gaasch WH. Surgical procedures in severe chronic mitral valve regurgitation. http://www.uptodate.com/home. Accessed Dec. 9, 2014.
- Nishimura RA, et al. 2014 ACC/AHA valve guidelines: Earlier intervention for chronic mitral regurgitation. Heart. 2014;100:905.
- Aldea GS. Minimally invasive aortic and mitral valve surgery. http://www.uptodate.com/home. Accessed Dec. 8, 2014.
- Otto CM. Acute mitral regurgitation in adults. http://www.uptodate.com/home. Accessed June 6, 2014.
- Gaasch WH, et al. Valvular heart disease induced by drugs. http://www.uptodate.com/home. Accessed Dec. 9, 2014.
- Nishimura RA, et al. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: Executive summary. Journal of the American College of Cardiology. 2014;63:2438.
- What is atrial fibrillation? National Heart, Lung, and Blood Institute. http://www.nhlbi.nih.gov/health/health-topics/topics/af. Accessed Dec. 9, 2014.
- Rehfeldt KH, et al. Robot-assisted mitral valve repair. Journal of Cardiothoracic and Vascular Anesthesia. 2011;25:721.
- Suri RM, et al. Minimally invasive heart surgery: How and why in 2012. Current Cardiology Reports. 2012;14:171.
- Bhamra-Ariza P, et al. The MitraClip experience and future percutaneous mitral valve therapies. Heart, Lung & Circulation. 2014;23:1009.
- Cullen MW, et al. Transvenous, antegrade Melody valve-in-valve implantation for bioprosthetic mitral and tricuspid valve dysfunction: A case series in children and adults. JACC: Cardiovascular Interventions. 2013;6:598.
- What causes cardiomyopathy? National Heart, Lung, and Blood Institute. http://www.nhlbi.nih.gov/health/health-topics/topics/cm/causes. Accessed Dec. 10, 2014.
- What cause an arrhythmia? National Heart, Lung, and Blood Institute. http://www.nhlbi.nih.gov/health/health-topics/topics/arr/causes. Accessed Dec. 10, 2014.
- Rihal CS, et al. Principles of percutaneous paravalvular leak closure. JACC: Cardiovascular Interventions. 2012;5:121.
- Golden AK. Decision Support System. Mayo Clinic, Rochester, Minn. Dec. 11, 2014.
- Suri RM (expert opinion). Mayo Clinic, Rochester, Minn. Dec. 30, 2014.
- Nkomo VT (expert opinion). Mayo Clinic, Rochester, Minn. Jan. 2, 2015.
- Suri RM, et al. Survival advantage and improved durability of mitral repair for leaflet prolapse subsets in the current era. The Annals of Thoracic Surgery. 2006;82:819.
- Suri RM, et al. Robotic mitral valve repair for all categories of leaflet prolapse: Improving patient appeal and advancing standard of care. Mayo Clinic Proceedings. 2011;86:838.
- Suri RM, et al. Improving affordability through innovation in the surgical treatment of mitral valve disease. Mayo Clinic Proceedings. 2013:88:1075.
- U.S. News Best Hospitals 2014-15. U.S. News & World Report. http://health.usnews.com/best-hospitals/rankings. Accessed Dec. 29, 2014.
- Suri RM, et al. Association between early surgical intervention vs watchful waiting and outcomes for mitral regurgitation due to flail mitral valve leaflets. Journal of the American Medical Association. 2013;310:609.
- Suri RM, et al. Robotic mitral valve repair for all prolapse subsets using techniques identical to open valvuloplasty: Establishing the benchmark against which percutaneous interventions should be judged. The Journal of Thoracic and Cardiovascular Surgery. 2011;142:970.
- Suri RM, et al. Recurrent mitral regurgitation after repair: Should the mitral valve be re-repaired? The Journal of Thoracic and Cardiovascular Surgery. 2006;132:1390.
- Constans DM. Echo Report Yearly Volumes. Mayo Clinic, Rochester, Minn. Accessed Jan. 12, 2015.
- Algarni KD, et al. Robotic-assisted mitral valve repair: Surgical technique. Multimedia Manual of Cardiothoracic Surgery. 2014;2014:e1. http://mmcts.oxfordjournals.org/content/2014/mmu022.full?sid=f176f3ea-c51d-42cc-871f-9c7d8b10c943. Accessed Jan. 9, 2015.
- Suri RM, et al. Quality of life after early mitral valve repair using conventional and robotic approaches. The Annals of Thoracic Surgery. 2012;93:761.
- Sorajja R, et al. The learning curve in percutaneous repair of paravalvuloar prosthetic regurgitation: An analysis of 200 cases. Journal of the American College of Cardiology. 2014;7:521.
- Miller HL. Decision Support System. Mayo Clinic, Rochester, Minn. Accessed Dec. 29, 2014.
- Severson RM. Society of Thoracic Surgeons National Database. Accessed Jan. 15, 2015.
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Mitral valve regurgitation