Clinical trials: Functional Mitral Regurgitation
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 Regurgitation, Mitral Insufficiency
ATLAS (AltaValve) Pivotal Trial
This is a prospective, single arm, multicenter, clinical trial designed to evaluate the safety and performance of the AltaValve System for the treatment of mitral regurgitation in a targeted patient population.
- Conditions
- Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Incompetence, Mitral Valve Regurgitation
- Trial name
- ATLAS (NCT06465745)
- Testing
- AltaValve System.
- Where
- 58 sites in United States, Canada and 5 more
- Volunteers
- 450 people
- Sponsor
- 4C Medical Technologies, Inc.
Mitral Regurgitation Functional, Mitral Valve Disease
A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation
To evaluate the feasibility and safety of the Millipede Transcatheter Annuloplasty Ring System in subjects with functional mitral regurgitation
- Conditions
- Mitral Regurgitation Functional, Mitral Valve Disease, Cardiovascular Diseases
- Trial name
- NCT04147884
- Testing
- Millipede Transcatheter Annuloplasty Ring System (Millipede System)
- Where
- 4 sites in United States, Australia
- Volunteers
- 4 people
- Sponsor
- Boston Scientific Corporation
Functional Mitral Regurgitation, Mitral Regurgitation
The CINCH-FMR Post-Market Registry: Percutaneous Repair in Functional Mitral Regurgitation
This is a retrospective and prospective, multi-center, post-market observational registry study. The primary objective of this post market registry is to continue to evaluate the long term safety and performance of the Carillon®…
- Trial name
- CINCH-FMR (NCT05677568)
- Testing
- Carillon Mitral Contour System
- Where
- 19 sites in Germany
- Volunteers
- 250 people
- Sponsor
- Cardiac Dimensions, Inc.
Mitral Valve Regurgitation
CardiAQ-Edwards™ Transcatheter Mitral Valve Replacement (TMVR) Study
Clinical study to evaluate the safety and performance of the CardiAQ-Edwards™ Transcatheter Mitral Valve
- Trial name
- RELIEF (NCT02722551)
- Testing
- Transcatheter Mitral Valve Re-placement (TMVR) with the CardiAQ-Edwards™ Transcatheter Mitral Valve
- Where
- 15 sites in Canada, Denmark and 5 more
- Sponsor
- Edwards Lifesciences
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 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 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
The JensClip Transcatheter Valve Repair System for Treating Functional Mitral Regurgitation
To evaluate the efficacy and safety of the JensClip transcatheter valve repair system for patients with moderate-severe or greater (MR ≥ 3+) functional mitral regurgitation (FMR) who have received adequate treatment but are still…
- Trial name
- NCT05931900
- Testing
- moderate-severe or greater (MR ≥ 3+) functional mitral regurgitation (FMR) patients
- Where
- China
- Volunteers
- 129 people
- Sponsor
- Jenscare Scientific
Functional Mitral Regurgitation
Percutaneous Left Ventricular Reshaping to Reduce Functional Mitral Regurgitation and Improve LV Function
The study is designed to demonstrate the safety, feasibility and potential efficacy of using the AccuCinch® System to reduce functional mitral regurgitation.
- Trial name
- LVRESTORESA (NCT01899573)
- Testing
- AccuCinch® Ventriculoplasty System
- Where
- Colombia
- Volunteers
- 8 people
- Sponsor
- Ancora Heart, Inc.
Mitral Regurgitation Functional
Noninferiority Trial of MitraClip Implantation Strategies: 1 Clip vs. 2 Clips in Patients With Functional Mitral Regurgitation
Implantation of the MitraClip has become the most frequently used percutaneous technique to treat significant (grade 3+ or 4+) mitral regurgitation (MR) in elderly patients deemed inoperable or at high surgical risk.
- Trial name
- One-Plus-One (NCT03503851)
- Testing
- MitraClip implantation
- Sponsor
- Asklepios proresearch
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 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 Regurgitation Functional
Safety and Effectiveness Study of Dragonfly System for Functional Mitral Regurgitation
To confirm the effectiveness and safety of the Dragonfly transcatheter mitral valve repair system for the treatment of chronic moderate to severe (3+) or severe (4+) functional mitral regurgitation (FMR) who remained clinically…
- Trial name
- NCT04733404
- Testing
- Dragonfly Transcatheter Mitral Valve Repair System
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Hangzhou Valgen Medtech Co., Ltd
Mitral Valve Regurgitation (Degenerative or Functional)
Mitral Annular Repair With the CathHELIX™ Transcatheter System in Subjects With FMR
Patients with functional mitral regurgitation classified as moderate to severe (3+) or severe (4+) that are symptomatic (NYHA Class II-IV) will be evaluated for treatment using the CathHELIX Transcatheter Mitral Annuloplasty…
- Trial name
- MARCH (NCT07188233)
- Testing
- Transcatheter Mitral Valve Repair
- Where
- 2 sites in Georgia, Lithuania
- Volunteers
- 5 people
- Sponsor
- HVR Cardio Oy
Mitral Valve Regurgitation (Degenerative or Functional)
TVMR With the Innovalve System Trial - First In Human Israel
Study to evaluate the safety and performance of the Innovalve mitral valve replacement system
- Trial name
- TWIST-FIHIL (NCT05688514)
- Testing
- Innovalve MR system
- Where
- Israel
- Volunteers
- 1 people
- Sponsor
- Edwards Lifesciences
Cardiovascular Diseases
A Randomized Study of the MitraClip Device in Heart Failure Patients With Clinically Significant Functional Mitral Regurgitation
This trial is a randomized study of the MitraClip device in heart failure patients with clinically significant functional mitral regurgitation.
- Trial name
- RESHAPE-HF (NCT01772108)
- Testing
- MitraClip
- Where
- 29 sites in Austria, Belgium and 8 more
- Volunteers
- 42 people
- Sponsor
- Abbott Medical Devices
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.
Nutritional Status
A Clinical Study to Investigate the Effects of Creatine Supplementation on Muscle Energetics and Cognitive Function in Young Healthy Male Athletes and an Ageing Population
This study will examine the impact of creatine supplementation on muscle function and cognitive performance in young and older subjects.
- Trial name
- NCT02058654
- Testing
- Creatine
- Where
- United Kingdom
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline