Clinical trials: Mitral Regurgitation
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
The REValve Clinical Trial an Evaluation Of the ReValve Palmetto Valve for the Replacement of the Native Mitral VaLVE
An evaluation of the ReValve System for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve surgery.
- Trial name
- The REsOLVE Tr (NCT07450911)
- Testing
- ReValve System
- Where
- 3 sites in Georgia
- Volunteers
- 20 people
- Sponsor
- ReValve Solutions Inc.
Mitral Regurgitation, Mitral Disease
SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation
This study will evaluate the safety and functionality of the SAPIEN M3 System in patients with symptomatic, severe MR and will provide guidance for future clinical study designs utilizing the SAPIEN M3 System.
- Trial name
- SAPIEN M3 EFS (NCT03230747)
- Testing
- Edwards SAPIEN M3 System
- Where
- 9 sites in United States, Canada
- Volunteers
- 72 people
- Sponsor
- Edwards Lifesciences
Mitral Regurgitation
EFS of the CardioMech MVRS
Safety and performance evaluation of the CardioMech Mitral Valve Repair System (MVRS) in patients with degenerative mitral valve regurgitation.
- Trial name
- NCT04820764
- Testing
- CardioMech MVRS
- Where
- 12 sites in United States
- Volunteers
- 35 people
- Sponsor
- CardioMech AS
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
Structural Heart Disease, Mitral Valve Regurgitation
The Asia-Pacific Mitral & Tricuspid Valve-in-Valve/Valve-in-Ring Registry
A significant number of patients with severe mitral and tricuspid valve disease have been previously treated with either valve repair with annuloplasty rings or valve replacement with bioprosthetic/mechanical valves.
- Trial name
- AP ViV (NCT07296016)
- Where
- Hong Kong
- Volunteers
- 15 people
- Sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
Mitral Regurgitation, Atrial Fibrillation
Optimal PeriproCeduraL AnticOagulation in Structural Transseptal Interventions
The transcatheter edge to edge mitral valve repair (TEER) and left atrial appendage closure (LAAC) are the interventional cardiology procedures that require periprocedural anticoagulation with unfractionated heparin (UFH).
- Conditions
- Mitral Regurgitation, Atrial Fibrillation, Anticoagulation
- Trial name
- STOP CLOT (NCT05305612)
- Testing
- early anticoagulation, late anticoagulation
- Where
- 5 sites in Poland
- Volunteers
- 410 people
- Sponsor
- National Institute of Cardiology, Warsaw, Poland
Mitral Regurgitation
Cephea Early Feasibility Study
The objective of this study is to evaluate the preliminary safety and effectiveness of the Cephea Mitral Valve System for the treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral…
- Trial name
- NCT05061004
- Testing
- Cephea Mitral Valve System
- Where
- 22 sites in United States, Canada
- Volunteers
- 90 people
- Sponsor
- Abbott Medical Devices
Mitral Regurgitation, Mitral Stenosis
Cephea South America Feasibility Study
The objective of this study is to evaluate the preliminary safety and effectiveness of the Cephea Mitral Valve System for the treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral…
- Trial name
- NCT07244939
- Testing
- Cephea Mitral Valve System
- Where
- 3 sites in Brazil, Chile
- Volunteers
- 20 people
- Sponsor
- Abbott Medical Devices
Atrial Functional Mitral Regurgitation
Safety and Efficacy of Transcatheter Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation
This study is a prospective, randomized, parallel-control, open-label, multicenter clinical trial. Eligible subjects will be randomized in a 1:1 ratio to the Device group (Interventional group) or to no Device group (Control…
- Trial name
- STAR (NCT07414225)
- Testing
- Transcatheter Edge-to-Edge Repair, Guideline-Directed Medical Therapy (GDMT) for cardiovascular disease
- Where
- China
- Volunteers
- 400 people
- Sponsor
- Beijing Anzhen Hospital
Mitral Regurgitation, Mitral Stenosis
Abbott Cephea Mitral Valve Disease Registry
The objective of this registry is to gather clinical data on symptomatic patients with mitral valve disease, including patients with mitral regurgitation, mitral stenosis, and mixed mitral valve disease.
- Conditions
- Mitral Regurgitation, Mitral Stenosis, Mitral Valve Disease, Mitral Valve (MV) Regurgitation
- Trial name
- NCT07069673
- Where
- 24 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation (AF), Mitral Valve (MV) Regurgitation
Catheter Ablation for AF in Patients With Severe Mitral Regurgitation After Successful Transcatheter Mitral-Valve Repair
CABA-MiTRA-AFNET12 is a non-commercial, parallel-group, prospective, randomised, open, blinded endpoint assessment (PROBE), multi-centre, therapy strategy trial.
- Trial name
- NCT07380932
- Testing
- Usual Care, Pulmonary Vein Isolation
- Where
- 4 sites in Germany
- Volunteers
- 956 people
- Sponsor
- Atrial Fibrillation Network
Mitral Regurgitation Functional
TEER In dynaMic sEvere Functional Mitral Regurgitation (TIMER)
Functional mitral regurgitation is a highly dynamic disease. Some patients exhibit only moderate(2+) functional mitral regurgitation at rest, which deteriorates to moderate-to-severe or severe FMR(3+ or 4+) during stress-termed…
- Trial name
- NCT07197021
- Testing
- TEER, GDMT
- Where
- China
- Volunteers
- 540 people
- Sponsor
- Sun Yat-sen University
Mitral Regurgitation
Anchord Mitral Chordal Repair System - FIH
The goal of this clinical trial is to generate initial human clinical experience and evaluate procedural feasibility, device deployment, and early safety under controlled First-In-Human conditions for the Anchord Mitral Chordal…
- Trial name
- NCT07671820
- Testing
- Anchord device implantation
- Volunteers
- 5 people
- Sponsor
- Lifecord Otd
Mitral Regurgitation, Valvular Heart Disease
In Search of Best Practices for Patients With Heart Failure and Secondary Mitral Regurgitation: An Evaluation of the Inova Heart Failure Treatment Algorithm
The overarching goal of this research proposal is to study the feasibility and clinical impact of implementing an Inova system-wide heart failure treatment algorithm for patients with symptomatic heart failure due to reduced left…
- Conditions
- Mitral Regurgitation, Valvular Heart Disease, Heart Failure
- Trial name
- NCT06675448
- Testing
- MitraClip, Moderate MR
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Inova Health Care Services
Mitral Regurgitation
EFS of Posterior Leaflet Replacement to Reduce Mitral Regurgitation (United States)
The goal of this early feasibility clinical trial is to learn if the device MR-ace Implant and Delivery System works in patients with moderate or severe mitral valve regurgitation.
- Trial name
- EXPLORE-MRace (NCT07517588)
- Testing
- MR-ace Implant and Delivery System
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Polares Medical SA
Iatrogenic ASD, Mitral Regurgitation
Iatrogenic Atrial Septal Defect Gradient for Intraprocedural Success After M-teer
Transcatheter mitral edge-to-edge repair (M-TEER) has become an established minimally invasive therapy for patients with severe mitral regurgitation (MR) who are at high or prohibitive surgical risk.
- Trial name
- IASIS (NCT07798037)
- Testing
- M-TEER
- Where
- Greece
- Volunteers
- 100 people
- Sponsor
- Hippocration General Hospital
Mitral Regurgitation
Capstan Medical TMVR Study: FIH
This study is a prospective, multi-center, non-randomized first in human study to evaluate the safety and feasibility of the Capstan Medical TMVR System for intervention in adults with moderate-severe or greater mitral…
- Trial name
- NCT06600191
- Testing
- Capstan System transcatheter mitral valve replacement
- Where
- 4 sites in Australia, Brazil and 2 more
- Volunteers
- 10 people
- Sponsor
- Capstan Medical
Atrial Functional Mitral Regurgitation
Effects of VALsartan On atRIAl Mitral Regurgitation (VALORIA) - Pilot
The goal of this clinical trial is to learn whether valsartan can slow the progression of atrial functional mitral regurgitation (AFMR) in adults with preserved left ventricular ejection fraction.
- Trial name
- VALORIA-Pilot (NCT07539298)
- Testing
- Valsartan
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- Jonathan Beaudoin
Mitral Regurgitation
Beating Heart Mitral Valve Repair With the HARPOON™ System
The objective of the study is to evaluate the safety and effectiveness of the HARPOON™ System in the treatment of patients with severe degenerative mitral regurgitation (DMR).
- Trial name
- RESTORE (NCT04375332)
- Testing
- HARPOON™ Beating Heart Mitral Valve Repair System
- Where
- 9 sites in United States
- Volunteers
- 25 people
- Sponsor
- Edwards Lifesciences