Clinical trials: Functional Mitral Regurgitation
Functional Mitral Regurgitation, Heart Failure
The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMR
The objective of this prospective, randomized, double- blinded (patient and assessors), sham-controlled clinical trial is to assess the safety and efficacy of the CMCS in treating heart failure with functional regurgitation (FMR).
- Conditions
- Functional Mitral Regurgitation, Heart Failure, Mitral Valve Insufficiency, Heart Diseases
- Trial name
- NCT03142152
- Testing
- Carillon Mitral Contour System, Guideline Directed Heart Failure Medication
- Where
- 92 sites in United States, Canada and 6 more
- Volunteers
- 300 people
- Sponsor
- Cardiac Dimensions, Inc.
Mitral Regurgitation Functional
Early Feasibility Study (EFS) of the Nyra Cardiac Leaflet Enhancer (CARLEN) System
Safety and performance evaluation of the CARLEN System in patients with functional mitral valve regurgitation.
- Trial name
- ENHANCE EFS (NCT07503236)
- Testing
- CARLEN System
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Nyra Medical, Inc.
Mitral Valve Regurgitation (Degenerative or Functional)
TVMR With the Innovalve System Trial - Pilot Study in Italy
Study to evaluate the safety and performance of the Innovalve mitral valve replacement system
- Trial name
- TWIST-PILOT-IT (NCT05010746)
- Testing
- Innovalve TMVR system
- Where
- Italy
- Volunteers
- 4 people
- Sponsor
- Edwards Lifesciences
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
Functional Mitral Regurgitation, Heart Failure
The BOSS Study: An Acute Evaluation of Anatomical and Geometric Changes Using the Bladder on a Stick System (BOSS)
The objective of the BOSS Study is to assess acute anatomical and geometric annular and ventricular changes that occur when strategically positioned an external inflatable chambers are applied to the outside of the heart.
- Trial name
- BOSS (NCT03228381)
- Testing
- BOSS Device
- Where
- 3 sites in United States, Paraguay
- Volunteers
- 4 people
- Sponsor
- Mardil Medical
Mitral Regurgitation, Mitral Valve Regurgitation
Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional MR
The COAPT Continued Access Study (CAS) is an extension of the COAPT RCT under the same IDE (G120024). COAPT CAS was a single-arm, prospective, multicenter continued access registry that enrolled heart failure patients with…
- Trial name
- COAPT CAS (NCT07227675)
- Testing
- MitraClip® NT System
- Where
- 32 sites in United States
- Volunteers
- 162 people
- Sponsor
- Abbott Medical Devices
Mitral Regurgitation
Carillon Mitral Contour System for Treatment of Exercise Induced Functional Mitral Regurgitation
Evaluate the hemodynamic and anatomical effect of the commercially available CMCS system within its current indication on a subset of patients with exercise induced mitral regurgitation.
- Trial name
- EXERCISE FMR (NCT05040451)
- Testing
- Carillon Mitral Contour System
- Sponsor
- Cardiac Dimensions Pty Ltd
Mitral Valve Regurgitation (Degenerative or Functional)
TVMR With the Innovalve System Trial - TWIST-BE TWIST-PILOT-BE
Study to evaluate the safety and performance of the Innovalve mitral valve replacement system
- Trial name
- NCT05263375
- Testing
- Innovalve TMVR system
- Sponsor
- Innovalve Bio Medical Ltd.
Degenerative Mitral Valve Disease, Mitral Regurgitation
Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve…
- Conditions
- Degenerative Mitral Valve Disease, Mitral Regurgitation, Mitral Insufficiency, Functional Mitral Regurgitation
- Trial name
- CLASP IID/IIF (NCT03706833)
- Testing
- Edwards PASCAL System, Abbott Mitraclip System
- Where
- 81 sites in United States, Canada and 2 more
- Volunteers
- 1,247 people
- Sponsor
- Edwards Lifesciences
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 Regurgitation
Mitralign Percutaneous Annuloplasty System for Chronic Functional Mitral Valve Regurgitation
The purpose of this study is to test the safety and device performance of the Mitralign system ("MPAS") to treat functional mitral valve regurgitation.
- Trial name
- ALIGN (NCT01740583)
- Testing
- percutaneous annuloplasty
- Where
- 8 sites in Colombia, France and 2 more
- Volunteers
- 50 people
- Sponsor
- Mitralign, Inc.
Mitral Valve Regurgitation (Degenerative or Functional)
TVMR With the INNOVALVE System Trial - Early Feasibility Study
Study to evaluate the safety and performance of the INNOVALVE system
- Trial name
- TWIST-EFS (NCT04919980)
- Testing
- INNOVALVE system
- Where
- 21 sites in United States
- Volunteers
- 85 people
- Sponsor
- Edwards Lifesciences
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
Functional Mitral Regurgitation, Atrial Fibrillation
An Initial Evaluation of the Carillon Mitral Contour System for Treatment of Atrial Function Mitral Regurgitation
The objective of this prospective, multi-center trial is to assess the effectiveness of the CARILLON Mitral Contour System in treating patients with moderate-to-severe atrial functional mitral regurgitation (aFMR)
- Conditions
- Functional Mitral Regurgitation, Atrial Fibrillation, Atrial Functional Mitral Regurgitation
- Trial name
- AFIRE (NCT04529928)
- Testing
- Carillon Mitral Contour System
- Where
- 2 sites in Australia, Greece
- Volunteers
- 4 people
- Sponsor
- Cardiac Dimensions Pty Ltd
Functional Mitral Regurgitation, Heart Failure
Mitral Loop Cerclage(MLC) for Reducing Functional Mitral Regurgitation
To evaluate safety and feasibility of Mitral Loop Cerclage(MLC) Annuloplasty with CSTV for repair of functional mitral regurgitation.
- Trial name
- NCT02471664
- Testing
- Mitral Loop Cerclage Annuloplasty
- Where
- 2 sites in United States, South Korea
- Volunteers
- 5 people
- Sponsor
- Tau-MEDICAL Co., Ltd.
Functional Mitral Regurgitation
Bio Refine for Functional Mitral Regurgitation - a Safety & Feasibility Study
The purpose of this study is to evaluate the safety and feasibility of the Bio Refine Coriofix System and determine if it might help in treatment of functional mitral regurgitation.
- Trial name
- NCT06583876
- Testing
- Coriofix System
- Where
- 8 sites in Hungary, Israel and 2 more
- Volunteers
- 15 people
- Sponsor
- Bio Refine Ltd.
Mitral Regurgitation, Valve Heart Disease
SATURN Transcatheter Mitral Valve Replacement for Functional Mitral Regurgitation
This study is a prospective, single-arm, multi-center feasibility clinical study of the SATURN TA System for the treatment of NYHA Class ≥ II patients with severe functional mitral regurgitation who are not suitable for surgical…
- Conditions
- Mitral Regurgitation, Valve Heart Disease, Heart Valve Diseases, Mitral Valve Disease
- Trial name
- NCT04464876
- Testing
- SATURN TA System
- Where
- 3 sites in Denmark, Hungary and 1 more
- Volunteers
- 20 people
- Sponsor
- InnovHeart
Mitral Regurgitation, Mitral Valve Regurgitation
A Study of Percutaneous Repair of Functional Mitral Regurgitation Using the Ancora Heart, Inc. AccuCinch® Ventricular Repair System - The CINCH-2 Study
Prospective single-arm study of the AccuCinch® Ventriculoplasty System in the treatment of mitral valve regurgitation through subvalvular mitral repair.
- Conditions
- Mitral Regurgitation, Mitral Valve Regurgitation, Functional Mitral Regurgitation
- Trial name
- CINCH-2 (NCT00800046)
- Testing
- AccuCinch® Ventriculoplasty System
- Where
- 8 sites in Austria, Germany and 1 more
- Volunteers
- 16 people
- Sponsor
- Ancora Heart, Inc.
Mitral Valve Regurgitation, Left Ventricular Dysfunction
RESTOR-MV: Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve
The purpose of this prospective, randomized, multi-center, pivotal trial is to compare the safety and effectiveness of the off-pump, closed heart Coapsys System (Myocor, Inc.) to open surgical repair of the mitral valve using an…
- Conditions
- Mitral Valve Regurgitation, Left Ventricular Dysfunction, Heart Failure
- Trial name
- NCT00120276
- Testing
- Less invasive mitral valve repair
- Where
- 10 sites in United States
- Volunteers
- 250 people
- Sponsor
- Myocor
Mitral Regurgitation, Mitral Valve Disease
Caisson Transcatheter Mitral Valve Replacement (TMVR)
The purpose of this study is to assess the safety and performance of Transcatheter Mitral Valve Replacement (TMVR) system for the treatment of severe, symptomatic mitral regurgitation (MR).
- Conditions
- Mitral Regurgitation, Mitral Valve Disease, Mitral Valve Failure, Mitral Disease
- Trial name
- INTERLUDE (NCT03661398)
- Testing
- Transcatheter Mitral Valve Replacement
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Caisson Interventional LLC