Clinical trials: Mitral Regurgitation Functional
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 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
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 Regurgitation, Mitral Insufficiency
AltaValve Early Feasibility Study Protocol
Prospective, single-arm, multicenter study to evaluate the safety and performance of the AltaValve for the treatment of moderate to severe or severe mitral valve regurgitation in subjects who are considered high risk for…
- Conditions
- Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Incompetence, Mitral Valve Regurgitation
- Trial name
- NCT03997305
- Testing
- AltaValve
- Where
- 12 sites in United States
- Volunteers
- 15 people
- Sponsor
- 4C Medical Technologies, Inc.
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
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
Symptomatic Functional MR 3 or Greater
AMEND TS Early Feasibility Study
Valcare Medical AMEND Trans-Septal System is a mitral valve repair annuloplasty ring implanted in a trans-catheter method intended for correction of mitral regurgitation.
- Trial name
- NCT06951672
- Testing
- This study will evaluate the safety and functionality of the AMEND™ Trans-Septal System for annuloplasty as a therapy for mitral regurgitation.
- Where
- 11 sites in United States
- Volunteers
- 15 people
- Sponsor
- Valcare Medical Ltd.
Mitral Valve Regurgitation
Tiara™ Transcatheter Mitral Valve Replacement Study
To evaluate the safety and performance of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.
- Trial name
- TIARA-II (NCT03039855)
- Testing
- TIARA valve and transapical delivery system
- Where
- 20 sites in Germany, Israel and 4 more
- Volunteers
- 157 people
- Sponsor
- Shockwave Medical, Inc.
Mitral Regurgitation, Mitral Insufficiency
Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation
Prospective, controlled, multicenter clinical investigation with four trial cohorts: Randomized, Non-repairable, Severe Mitral Annular Calcification (MAC) and Severe Mitral Annular Calcification Continued Access Plan (MAC CAP).
- Conditions
- Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Insufficiency, Cardiovascular Diseases
- Trial name
- SUMMIT (NCT03433274)
- Testing
- Tendyne Mitral Valve System, MitraClip System
- Where
- 78 sites in United States, Canada
- Volunteers
- 103 people
- Sponsor
- Abbott Medical Devices
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
Heart Failure, Cardiomyopathies
Evaluate the Safety and Performance of the AccuCinch® Ventricular Repair System - The CorCinch-EU Study
This is prospective, non-randomized, single-arm, international, multicenter, clinical safety and performance clinical investigation to evaluate the AccuCinch® Ventricular Repair System for the treatment of heart failure, with or…
- Trial name
- NCT03183895
- Testing
- Left ventricular restoration
- Where
- 19 sites in Belarus, Belgium and 8 more
- Volunteers
- 132 people
- Sponsor
- Ancora Heart, Inc.
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 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
Ischemic Mitral Regurgitation, Functional Mitral Regurgitation
Epicardial Mitral Touch System for Mitral Insufficiency
To evaluate the safety and performance of the Mitral Touch System to treat mitral insufficiency in patients who are to undergo cardiac surgery with either a sternotomy or thoracotomy who present with moderate to severe ischemic…
- Trial name
- ENRAPTUS (NCT04396379)
- Testing
- Implant an epicardial device to reshape the mitral valve annulus
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Mitre Medical Corp.
Functional Mitral Regurgitation, Degenerrative Mitral Regurgitation
MitraClip Russia Trial
The MitraClip System is the first commercially available catheter-based option for the treatment of MR. The MitraClip System was developed as an alternate percutaneous technology which may serve as a viable therapeutic option for…
- Trial name
- NCT04350372
- Testing
- MitraClip Procedure
- Where
- Russia
- Volunteers
- 16 people
- Sponsor
- Abbott Medical Devices
Functional Mitral Regurgitation
Safety and Effectiveness Study of SQ-Kyrin System for Functional Mitral Regurgitation in EU
The investigation objective of this study is to evaluate the safety and effectiveness of the Transcatheter Mitral Valve Clip Delivery System and Steerable Guide Catheter in the population of FMR patients and the accessories…
- Trial name
- NCT06823700
- Testing
- SQ-Kyrin Transcatheter Mitral Valve Repair System
- Where
- Spain
- Volunteers
- 34 people
- Sponsor
- Shanghai Shenqi Medical Technology Co., 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.
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.
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 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