Clinical trials: Mitral Valve Failure
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 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
Mitral Valve Insufficiency, Mitral Valve Regurgitation
Real World Expanded Multicenter Study of the MitraClip® System (REALISM)
Prospective, multicenter, continued access registry of the MitraClip® Cardiovascular Valve Repair System in the treatment of mitral valve regurgitation.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation
- Trial name
- REALISM (NCT01931956)
- Testing
- MitraClip® implant
- Where
- 38 sites in United States
- Volunteers
- 965 people
- Sponsor
- Abbott Medical Devices
Mitral Valve Insufficiency, Mitral Valve Regurgitation
Feasibility Study of a Percutaneous Mitral Valve Repair System.
Prospective, multi-center, Phase I study of the Evalve Cardiovascular Valve Repair System (CVRS) in the treatment of mitral valve regurgitation. Patients will undergo 30-day, 6 month, 12 month, and 5 year clinical follow-up.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation
- Trial name
- EVEREST(I) (NCT00209339)
- Testing
- Percutaneous mitral valve repair (MitraClip Implant)
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- Abbott Medical Devices
Mitral Regurgitation
MitraClip System in Australia and New Zealand
The primary objective of the MitraClip System Australia and New Zealand (ANZ) Clinical Trial is to gather real-world clinical and health-economic outcome data to support the long-term safety, efficacy and economic value of the…
- Trial name
- MitraClipANZ (NCT01301625)
- Testing
- MitraClip Implant
- Where
- 6 sites in Australia
- Volunteers
- 78 people
- Sponsor
- Abbott Medical Devices
Mitral Stenosis With Insufficiency, Functional Mitral Regurgitation
AVJ-514 Japan Trial
The objective of the study is to confirm the reproducibility of the evidence of safety and efficacy of AVJ-514 System technology in Japanese subjects who have been deemed difficult for mitral valve surgery by the local site heart…
- Conditions
- Mitral Stenosis With Insufficiency, Functional Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Incompetence
- Trial name
- NCT02520310
- Testing
- AVJ-514
- Where
- 6 sites in Japan
- Volunteers
- 30 people
- Sponsor
- Abbott Medical Devices
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 Insufficiency, Mitral Valve Disease
PARTNER 3 Trial - Mitral Valve in Valve
To assess the safety and effectiveness of the SAPIEN 3 transcatheter heart valve in patients with a failing mitral bioprosthetic valve.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Disease, Mitral Valve Regurgitation, Heart Failure
- Trial name
- NCT03193801
- Testing
- Edwards SAPIEN 3 transcatheter valve, Model 9600TFX
- Where
- 12 sites in United States, Australia and 1 more
- Volunteers
- 53 people
- Sponsor
- Edwards Lifesciences
Heart Failure, Mitral Regurgitation
Implantation of a Permanent Interatrial Shunt to Reduce Left Atrial Filling Pressures Following MitraClip
This is an investigator initiated, prospective study to demonstrate the safety and feasibility of implantation of the V-Wave Interatrial Shunt System (herein called the "V-Wave Shunt" in patients immediately following…
- Trial name
- NCT04729933
- Testing
- V-Wave Shunt Placement
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- samir kapadia
Cardiomyopathy, Cardiovascular Diseases
Improving Mitral Repair for Functional Mitral Regurgitation
The investigators are interested in determining the best surgical technique to correct functional mitral regurgitation, as there is currently not one technique that is established to work better than the other.
- Conditions
- Cardiomyopathy, Cardiovascular Diseases, Congestive Heart Failure, Coronary Artery Disease
- Trial name
- IMPROVE-FMR (NCT03366649)
- Testing
- Undersizing Mitral Annuloplasty, Papillary Muscle Approximation
- Where
- 3 sites in United States
- Volunteers
- 34 people
- Sponsor
- Emory University
Coronary Artery Disease, Mitral Valve Regurgitation
Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol
The purpose of the study is to demonstrate the long term safety and effectiveness of the Carpentier-Edwards® PERIMOUNT Magna Mitral Valves in patients undergoing mitral valve replacement with or without concomitant procedures…
- Conditions
- Coronary Artery Disease, Mitral Valve Regurgitation, Mitral Valve Incompetence, Heart Failure
- Trial name
- NCT00853632
- Testing
- CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES
- Where
- 15 sites in United States, Austria and 2 more
- Volunteers
- 329 people
- Sponsor
- Edwards Lifesciences
Aortic Stenosis, Mitral Stenosis
ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Bioprostheses With a New Tissue Treatment Platform (COMMENCE)
The objective of this trial is to confirm that the modifications to tissue processing, valve sterilization and packaging do not raise any new questions of safety and effectiveness in subjects who require replacement of their…
- Conditions
- Aortic Stenosis, Mitral Stenosis, Aortic Valve Insufficiency, Mitral Valve Insufficiency
- Trial name
- COMMENCE (NCT01757665)
- Testing
- Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M
- Where
- 32 sites in United States, Canada and 1 more
- Volunteers
- 777 people
- Sponsor
- Edwards Lifesciences
Mitral Regurgitation, Mitral Valve Regurgitation
Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) and COAPT CAS
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…
- Conditions
- Mitral Regurgitation, Mitral Valve Regurgitation, Treatment of Functional Mitral Regurgitation in Symptomatic Heart Failure Subjects, Heart Failure
- Trial name
- COAPT (NCT01626079)
- Testing
- MitraClip System
- Where
- 86 sites in United States, Canada
- Volunteers
- 776 people
- Sponsor
- Abbott Medical Devices
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, Mitral Valve Regurgitation
Pivotal Study of a Percutaneous Mitral Valve Repair System
EVEREST II Randomized Controlled Trial (RCT) is a prospective, multi-center, randomized study of the MitraClip® System in the treatment of mitral valve regurgitation, randomizing patients to MitraClip or mitral valve surgery.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation
- Trial name
- EVERESTIIRCT (NCT00209274)
- Testing
- Percutaneous mitral valve repair using MitraClip implant, Mitral valve repair or replacement surgery
- Where
- United States
- Volunteers
- 279 people
- Sponsor
- Abbott Medical Devices
Mitral Valve Insufficiency, Atrial Fibrillation
Left Atrial Distensibility to Predict Left Ventricular Filling Pressure and Prognosis in Patients With Severe Mitral Regurgitation
A large left atrial (LA) volume, which represents chronic diastolic dysfunction, is associated with a poor outcome, regardless of systolic function.
- Conditions
- Mitral Valve Insufficiency, Atrial Fibrillation, Heart Failure
- Trial name
- NCT01172184
- Testing
- Cardiac catheterization
- Where
- Taiwan
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- Kaohsiung Veterans General Hospital.
Mitral Valve Failure
NHLBI DIR LAMPOON Study: Intentional Laceration of the Anterior Mitral Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Implantation
Background: Transcatheter mitral valve replacement (TMVR) is recommended for some people with mitral valve heart problems. But the usual TMVR techniques might cause an obstruction for some people.
- Trial name
- NCT03015194
- Testing
- Edwards SAPIEN 3 transcatheter heart valve, ASHI INTECC Astato XS 20
- Where
- 6 sites in United States
- Volunteers
- 32 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)