Clinical trials: Mitral Regurgitation
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
Mitral Regurgitation, Mitral Insufficiency
MiCLASP Post Market Clinical Follow-Up (PMCF) Study
This is a postmarket clinical follow up study on the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in transcatheter mitral…
- Trial name
- MiCLASP (NCT04430075)
- Testing
- Edwards PASCAL Transcatheter Valve Repair System and Edwards PASCAL Precision Transcatheter Valve Repair System
- Where
- 37 sites in Austria, Germany and 7 more
- Volunteers
- 1,000 people
- Sponsor
- Edwards Lifesciences
Degenerative Mitral Regurgitation
FIH ITA Study - Vesalius TMVr System for Symptomatic Degenerative Mitral Regurgitation
This first-in-human study evaluates the safety and performance of the Vesalius Transcatheter Mitral Valve Repair (TMVr) System in patients with degenerative mitral regurgitation.
- Trial name
- NCT07470788
- Testing
- Transcatheter Mitral Valve Repair
- Where
- Canada
- Volunteers
- 5 people
- Sponsor
- Vesalius Cardiovascular Inc.
Valvular Heart Disease Patients, Aortic Stenosis
Importance of Point-of-Care Ultrasound for Early Detection of Valvular and Cardiac Diseases (IMPROVE)
Heart valve disease and weakened heart muscle (left ventricular systolic dysfunction) are common in older adults and often go undetected until serious complications such as heart failure develop.
- Conditions
- Valvular Heart Disease Patients, Aortic Stenosis, Mitral Regurgitation, Left Ventricular Diastolic Dysfunction
- Trial name
- IMPROVE (NCT07756398)
- Testing
- Kosmos Torso-One AI-guided Point-of-Care Ultrasound (EchoNous, Inc.)
- Where
- 2 sites in United States
- Volunteers
- 1,088 people
- Sponsor
- University of Texas Southwestern Medical Center
Mitral Valve (MV) Regurgitation
A Prospective, Multicenter, Single-Arm Study to Support the Clinical Evidence Base for MRace as a Treatment Option for FMR Patients With Complex M-TEER Anatomies (FR)
A pilot study to evaluate the safety and performance of the MRace System to treat severe mitral regurgitation and to gather data on its performance thereby providing guidance for future clinical development.
- Trial name
- ACCESS-MR (FR) (NCT07757607)
- Testing
- Transcatheter mitral valve repair (MRace Implant and Delivery System)
- Volunteers
- 20 people
- Sponsor
- Polares Medical SA
Mitral Valve (MV) Regurgitation
A Prospective, Multicenter, Single-Arm Study to Support the Clinical Evidence Base for MRace as a Treatment Option for FMR Patients With Complex M-TEER Anatomies (AU)
A pilot study to evaluate the safety and performance of the MRace System to treat severe mitral regurgitation and to gather data on its performance thereby providing guidance for future clinical development.
- Trial name
- ACCESS-MR (AU) (NCT07757698)
- Testing
- Transcatheter mitral valve repair
- Volunteers
- 15 people
- Sponsor
- Polares Medical SA
Mitral Valve (MV) Regurgitation
A Prospective, Multicenter, Single-Arm Study to Support the Clinical Evidence Base for MRace as a Treatment Option for FMR Patients With Complex M-TEER Anatomies (DE)
A pilot study to evaluate the safety and performance of the MRace System to treat severe mitral regurgitation and to gather data on its performance thereby providing guidance for future clinical development.
- Trial name
- ACCESS-MR (DE) (NCT07757776)
- Testing
- Transcatheter mitral valve repair (MRace Implant and Delivery System)
- Volunteers
- 20 people
- Sponsor
- Polares Medical SA
Mitral Regurgitation Functional, Heart Failure With Reduced Ejection Fraction (HFrEF)
Achieving Optimal Medical Therapy Through Percutaneous Treatment of Secondary Mitral Regurgitation to Improve Outcome in Patients With HFrEF
The purpose of the ACHILLES-HF trial (ACHIeving optimaL medicaL therapy through pErcutaneous treatment of Secondary mitral regurgitation to improve outcome in Patients with Heart Failure with reduced ejection fraction) is to test…
- Trial name
- ACHILLES-HF (NCT07758023)
- Testing
- M-TEER, Standardized GDMT Up-Titration
- Volunteers
- 520 people
- Sponsor
- University Medical Center Mainz
Functional Mitral Regurgitation
EXPLORE FMR: Early Feasibility Study of the PLAR Implant and Delivery System to Treat Functional Mitral Regurgitation
An early feasibility study to evaluate the safety and feasibility of the PLAR Implant and Delivery System to treat severe functional mitral regurgitation and to gather preliminary data on its performance thereby providing…
- Trial name
- NCT04679714
- Testing
- Transcatheter mitral valve repair (PLAR Implant and Delivery System)
- Where
- Brazil
- Sponsor
- Polares Medical SA