Functional Mitral Regurgitation

9

Review clinical trials related to Functional Mitral Regurgitation. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Atrial Functional Mitral Regurgitation and Tricuspid Regurgitation

A prospective, observational cohort study designed to identify clinical phenotypes and evaluate predictors \& outcomes of functional mitral and tricuspid valve regurgitation in patients with atrial fibrillation. Participant will under go: * Baseline echocardiography * Cpex Echocardiography * Blood test: BNP * 1 year follow up Echocardiography Participants will be stratified into three subgroups: * Atrial Functional MR * Atrial Functional TR * Mixed MR \& TR

Participants needed: 141
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Barts & The London NHS TrustUpdated: Apr 21, 2026Locations: 1Duration: 1 Year
Eligibility criteria

Informed consent [+4]

Unwilling or unable to give consent [+2]

Status: Recruiting

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).

Participants needed: 300
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Cardiac Dimensions, Inc.Updated: Apr 13, 2026Locations: 92
Eligibility criteria

Symptomatic heart failure with functional (secondary) mitral regurgitation of at... [+11]

Presence of a mechanical or bio-prosthetic mitral valve or, mitral valve annulop... [+7]

Status: Recruiting

Secondary Mitral Regurgitation Treatment With MitraClip and Assessment by Cardiac Magnetic Resonance

This is a multi-center, prospective, observational study designed to evaluate the impact of LV myocardial fibrosis extent assessed by CMR on LV reverse remodeling and clinical outcomes post TEER. The target sample will be up to 125 patients enrolled to achieve 100 evaluable at 6 months of follow-up. Enrollment will occur at up to eight centers.

Participants needed: 125
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Minneapolis Heart Institute FoundationUpdated: Dec 23, 2025Locations: 6
Eligibility criteria

Concomitant PCI and TEER [+8]

Status: Recruiting

Phenotypic Classification of FMR With CMR

The goal of the current research is to develop personalized risk prediction for functional mitral regurgitation (FMR) patients through explainable unsupervised phenomapping enriched with advanced cardiac magnetic resonance (CMR) imaging biomarkers, and to determine the CMR predictors of reverse remodeling following modern therapies for FMR. The prospective study entails aiming to recruit 360 adult patients (ages \>18 years) with EF 10-50% and FMR RF\> 20%, who are clinically referred for CMR evaluation. Patients who enroll in our study will be referred for optimization of mGDMT and will undergo follow-up CMR studies at 6months. NICM patients who are fully medically optimized with significant FMR at the time of the baseline CMR and are referred for Mitraclip treatment will undergo follow-up CMR 6 months from Mitraclip intervention. NICM patients referred for mGDMT optimization, but have persistent or progressive FMR at the time of 6 month follow-up CMR and referred for Mitraclip therapy, will undergo a 2nd follow-up CMR 6 months from Mitraclip therapy.

Participants needed: 360
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: The Cleveland ClinicUpdated: Oct 20, 2025Locations: 1
Eligibility criteria

>moderate aortic regurgitation/stenosis, [+7]

Status: Recruiting

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. The study will include patients with symptomatic secondary mitral regurgitation in whom mitral surgery cannot and/or will not be offered as a treatment option (the risk is prohibitive). Potential patients will be screened to confirm that all inclusion/exclusion criteria are met, with final eligibility confirmation on day of procedure. All enrolled subjects who went through the procedure will be followed during the procedure to hospital discharge. Additional follow up time points are scheduled at 30 days, 6 months and 12 months post procedure.

Participants needed: 15
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Bio Refine Ltd.Updated: Mar 27, 2025Locations: 4
Eligibility criteria

Local heart team has determined that mitral valve surgery will not be offered as... [+5]

Untreated clinically significant coronary artery disease requiring revasculariza... [+12]

Status: Recruiting

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 devices when used in conjunction with the Transcatheter Mitral Valve Clip Delivery System and Steerable Guide Catheter.

Participants needed: 34
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Shanghai Shenqi Medical Technology Co., LtdUpdated: Feb 12, 2025Locations: 1
Eligibility criteria

Participant who has provided written informed consent for the investigation. [+14]

Life expectancy <1 year due to non-cardiac conditions or heart failure deemed su... [+27]

Status: Not yet recruiting

CAP-TEER: CerebrAl Protection During Transcatheter Edge-to-edge Repair

Transcatheter edge-to-edge repair of the mitral valve (M-TEER) is a well-established endovascular treatment option for patients with severe mitral regurgitation who are at high risk for surgery-related complications. However, the procedure carries a risk of clinically overt strokes and imaging-detected brain lesions, which may potentially be mitigated through the use of cerebral protection devices. This prospective, multi-center, randomized, controlled study aims to assess the efficacy and safety of cerebral protection device, compared to a control group undergoing unprotected M-TEER.

Participants needed: 120
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Xiao-dong ZhuangUpdated: Feb 7, 2025Locations: 1
Eligibility criteria

Age ≥18 years [+4]

Contraindication to MRI [+13]

Status: Not yet recruiting

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 or functional mitral regurgitation.

Participants needed: 10
Trial details
Age: 22+Biological sex: AllType: InterventionalSponsor: Mitre Medical Corp.Updated: Jan 4, 2023Locations: 1
Eligibility criteria

Moderate or greater (2+) ischemic [+5]

Any evidence of structural (chordal or leaflet) mitral valve disease [+20]

Status: Not yet recruiting

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 guidance for future clinical development. The study is a single-arm registry with the last follow-up visit at 5 years post-intervention. The study will enroll up to 10 patients at one (1) center in Brazil.

Participants needed: 10
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Polares Medical SAUpdated: Dec 22, 2020
Eligibility criteria

18 years of age or older [+6]

Severe tricuspid regurgitation [+30]