Clinical Trials Logo

Mitral Regurgitation clinical trials

View clinical trials related to Mitral Regurgitation.

Filter by:

NCT ID: NCT04029337 Recruiting - Clinical trials for Mitral Regurgitation

An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System

Start date: July 14, 2020
Phase: N/A
Study type: Interventional

Study to evaluate the feasibility, safety and performance of the HighLife trans-septal Transcatheter Mitral Valve in patients with moderate-severe and severe mitral regurgitation who are at high risk for surgical treatment.

NCT ID: NCT04009434 Recruiting - Aortic Stenosis Clinical Trials

Treatment of Concomitant Mitral Regurgitation by Mitral Valve Clipping in Patients With Successful Transcatheter Aortic Valve Implantation.

MITAVI
Start date: December 1, 2019
Phase: N/A
Study type: Interventional

To evaluate whether patients after successful transfemoral transcatheter aortic valve implantation (TAVI), who have concomitant, moderate to severe mitral regurgitation (MR) benefit from an additional treatment of this valve disease as well.

NCT ID: NCT03997305 Recruiting - Clinical trials for Mitral Regurgitation

AltaValve Early Feasibility Study Protocol

Start date: December 4, 2019
Phase: N/A
Study type: Interventional

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 mortality and morbidity from conventional open-heart surgery.

NCT ID: NCT03975998 Recruiting - Clinical trials for Mitral Regurgitation

Dutch-AMR: Early Mitral Valve Repair Versus Watchful Waiting in Asymptomatic Patients With Severe Mitral Regurgitation

Dutch-AMR
Start date: October 2016
Phase:
Study type: Observational [Patient Registry]

Rationale: Severe asymptomatic organic Mitral Valve (MV) regurgitation with preserved left ventricular (LV) function is a challenging clinical entity as data on the recommended treatment strategy for these patients are scarce and conflicting, which is reflected in current guidelines. European guidelines advocate a more conservative strategy i.e. watchful waiting, with yearly echocardiography, whilst American guidelines are more in favour of early surgery to reconstruct the MV, i.e. MV repair (in contrast to MV replacement) in order to prevent future LV dysfunction and complaints. A number of non-randomised trials show a favourable outcome of early surgery: in the study of Enriquez-Sarano et al. for instance, the early surgery strategy has shown to be associated with improved long-term survival, decreased cardiac mortality, and decreased morbidity compared with the conservative management [1]. On the other hand, non-randomised trials describe also that a conservative strategy (i.e. watchful waiting) can be safely accomplished. If facilitated surgery is performed in this population (50% at 10 years follow-up according to Rosenhek et al [2]), it has proven to be eventually associated with good perioperative and postoperative outcome when careful follow-up is being carried out [2]. Objective: To compare early MV repair versus watchful waiting in asymptomatic patients with severe organic mitral valve regurgitation and preserved left ventricular function. Study design: Multicenter, registry trial. Study population: 250 Asymptomatic patients (18-75 years old) with severe organic MV regurgitation and preserved left ventricular function. The current European Society of Cardiology (ESC) guidelines on Valvular Heart Disease will be applied [3]. These guidelines are also used in the Netherlands. Accordingly, patients with an indication for MV surgery will not be included. Intervention: Intervention will be early MV repair compared to a watchful waiting strategy.

NCT ID: NCT03958773 Recruiting - Clinical trials for Mitral Regurgitation

Cardiovalve Transfemoral System - FIM Study

Start date: October 12, 2017
Phase: N/A
Study type: Interventional

The Cardiovalve system is a replacement valve delivered through a transfemoral access and transseptal approach and is intended for symptomatic patients with Mitral regurgitation for whom surgical options are not feasible.

NCT ID: NCT03864848 Recruiting - Clinical trials for Mitral Regurgitation

Epicardial Mitral Repair Trial - ENRAPT-MR

ENRAPT-MR
Start date: December 18, 2017
Phase: N/A
Study type: Interventional

Mitral Touch System This device is designed to epicardially reshape the mitral valve annulus without the need for cardiopulmonary bypass (CPB) and open heart access (atriotomy), in patients with left ventricular dilation and ischemic or functional MR (mitral regurgitation (MR)).

NCT ID: NCT03706833 Recruiting - Clinical trials for Mitral Regurgitation

Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial

CLASP IID/IIF
Start date: November 30, 2018
Phase: N/A
Study type: Interventional

To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT)

NCT ID: NCT03705312 Recruiting - Heart Failure Clinical Trials

MitraClip for the Treatment of Moderate Functional Mitral Regurgitation: EVOLVE-MR

EVOLVE-MR
Start date: February 22, 2019
Phase: N/A
Study type: Interventional

This study evaluates the addition of transcatheter mitral valve repair with the MitraClip device to medical treatment in patients with heart failure and moderate functional mitral regurgitation to determine the impact of left ventricular remodelling and patients' functional capacity.

NCT ID: NCT03433274 Recruiting - Clinical trials for Cardiovascular Diseases

Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation

SUMMIT
Start date: June 15, 2018
Phase: N/A
Study type: Interventional

Prospective, controlled, multicenter clinical investigation with four trial cohorts: Randomized, Non-repairable, Severe Mitral Annular Calcification (MAC) and Severe Mitral Annular Calcification Continued Access Protocol (MAC CAP). Subjects in the Randomized cohort will be randomized in a 1:1 ratio to the trial device or to the MitraClip system. Subjects in the Non-repairable, Severe MAC, and Severe MAC CAP cohorts will receive the trial device. The objective of the Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT) is to evaluate the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System for the treatment of patients with symptomatic, moderate-to-severe or severe mitral regurgitation or for patients with symptomatic mitral valve disease due to severe mitral annular calcification. This randomized controlled trial will provide the opportunity to evaluate the safety and clinical benefits of the Tendyne Transcatheter Mitral Valve System compared to the MitraClip System in patients with symptomatic, moderate-to-severe or severe mitral regurgitation, within approved MitraClip indications. In addition, the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System will be evaluated in patients with severe mitral annular calcification who are at prohibitive risk for mitral valve surgery. Patients who are not suitable for mitral valve surgery for reasons other than severe mitral annular calcification and are also not suitable for transcatheter repair with MitraClip, will be enrolled in the Non-repairable cohort. Subjects will be seen at screening, pre- and post-procedure, discharge, 30 days, 3 months, 6 months, and annually through 5 years.

NCT ID: NCT03339115 Recruiting - Clinical trials for Mitral Regurgitation

AHEAD: European Feasibility Study of the Cardiovalve Transfemoral Mitral Valve System

AHEAD
Start date: April 23, 2018
Phase: N/A
Study type: Interventional

This study will evaluate the safety of the Cardiovalve Transfemoral Mitral Valve System with its associated procedure, and observe the device performance in reducing mitral regurgitation. Data collected in this clinical study will include 30-day safety and performance, and long-term clinical outcomes over a follow-up of 2 years.