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64 active trials for Mitral Regurgitation

3D Echocardiography and Cardiovascular Prognosis in Mitral Regurgitation

The 3D-PRIME study will analyse whether use of 3D echocardiography can improve risk stratification and cardiovascular outcome in patients with mitral regurgitation of different etiologies.

Start: April 2020

Transcatheter Mitral Valvuloplasty Pilot Study

This study is to evaluate the efficacy and safety of Transcatheter Mitral Valvuloplasty for Severe Mitral Regurgitation

Start: December 2020

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).

Start: June 2017

Evaluation of Robotic-assisted Mitral Surgery With the daVinci X Surgical System

Robotic assistance allows performance of mitral valve operations with a truly minimally invasive and totally thoracoscopic approach, with significant advantages for patients compared to sternotomy-based surgery. Nonetheless, its diffusion has been limited by: 1) significant learning curve and technical requirements; 2) increased immediate financial costs due to dedicated equipment and materials. The aim of the present study is to perform a prospective data collection and evaluation of the in-hospital and follow-up clinical results of mitral valve repair using the last generation DaVinci X robotic platform. A cost-effectiveness analysis of this approach will be also conducted, under a global healthcare system perspective (including the overall patients' pathway starting from diagnosis of mitral valve disease until the completion of the 1st postoperative year). Since the 'competitor' surgical technique is not represented by sternotomy-based mitral surgery, but instead by minimally invasive, video-assisted mitral surgery, patients operated on using such technique will serve as controls.

Start: March 2020

Left Chamber Function in Mitral Regurgitation and Predicting Outcome After Replacement and Targeting for Early Surgery

The study aims to analyze the role of left ventricular and left atrial functional parameters by speckle tracking echocardiography in predicting outcome after mitral valve replacement and targeting for early intervention compared to guideline parameters.

Start: September 2021

Phono- and Electrocardiogram Assisted Detection of Valvular Disease

The diagnosis of valvular heart disease (VHD), or its absence, invariably requires cardiac imaging. A familiar and inexpensive tool to assist in the diagnosis or exclusion of significant VHD could both expedite access to life-saving therapies and reduce the need for costly testing. The FDA-approved Eko Duo device consists of a digital stethoscope and a single-lead electrocardiogram (ECG), which wirelessly pairs with the Eko Mobile application to allow for simultaneous recording and visualization of phono- and electrocardiograms. These features uniquely situate this device to accumulate large sets of auscultatory data on patients both with and without VHD. In this study, the investigators seek to develop an automated system to identify VHD by phono- and electrocardiogram. Specifically, the investigators will attempt to develop machine learning algorithms to learn the phonocardiograms of patients with clinically important aortic stenosis (AS) or mitral regurgitation (MR), and then task the algorithms to identify subjects with clinically important VHD, as identified by a gold standard, from naïve phonocardiograms. The investigators anticipate that the study has the potential to revolutionize the diagnosis of VHD by providing a more accurate substitute to traditional auscultation.

Start: February 2018

The MitraClip® EXPAND Study of the Next Generation of MitraClip® Devices

The MitraClip EXPAND Study (A Contemporary, Prospective Study Evaluating Real-world Experience of Performance and Safety for the Next Generation of MitraClip Devices) is designed to confirm the safety and performance of the MitraClip NTR System and MitraClip XTR System.

Start: April 2018

Transcatheter Mitral Valve Repair as Bridge Therapy to Heart Transplantation

The aim of this study is to report medium-term outcomes after the use of transcatheter mitral valve repair (TMVR) with MitraClip as a bridge therapy to heart transplantation (HTx) in patients with mitral regurgitation (MR) and end-stage heart failure (HF).

Start: June 2018

Neochordae Technique in Mitral Valve Repair

Mitral valve (MV) repair has turned into a preferable option for surgeons over the MV replacement. Since the 1960s, Surgeons use this technique for more efficiency and durability. On the other hand, the proper determination of length and placement of artificial neochordae is still a challenge beyond this technique. These challenges are still a vital area for research and debate between surgeons and researchers. In our novel technique,Investigators are not depending either on the preoperative investigations or intraoperative reference chordae in the adjustment of the optimal length of the neochordae, however, Researchers depend on the personal adjustment of the chordal length to the prolapsed scallop.

Start: March 2020

Safety and Performance Study of the MitralStitch Repair System.

The main objective is to assess the effectiveness and safety of the MitralStitch repair system in patients with moderate to severe and severe mitral regurgitation.

Start: July 2019

MitraClip in Acute Mitral Regurgitation

Acute MR may develop in the setting of an acute myocardial infarction (AMI) as a result of papillary muscle dysfunction or rupture, and these patients are grossly underrepresented in MitraClip registries. Our group has recently published the Spanish experience with MitraClip in acute MI, but only 5 patients could be collected. However, the results of our initial experience are highly encouraging since patients performed well in such life-threatening condition. In order to expand the information of the device in this condition, our aim is to start a multinational registry in Europe.

Start: January 2017

MitraClip® Registry

Percutaneous mitral valve repair with the MitraClip® system has emerged as a therapeutic alternative to surgical valve repair (PMVR) in high risk patients. The aim of this registry is to collect prospectively and systematically clinical research data from patients undergoing PMVR with the MitraClip® system. This registry is an open-end observational study to assess the characteristics and outcomes patients with severe mitral regurgitation undergoing PMVR.

Start: January 2014

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

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.

Start: December 2019

Caisson Transcatheter Mitral Valve Replacement (TMVR)

The purpose of this study is to assess the safety and performance of Transcatheter Mitral Valve Replacement (TMVR) system for the treatment of severe, symptomatic mitral regurgitation (MR).

Start: July 2017

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

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.

Start: April 2020

The Prognostic Impact of Using High-dose Hydralazine in Severe Systolic Heart Failure With Hemodynamically Significant Mitral Regurgitation

Background: Severe systolic heart failure would be complicated with low cardiac output and high left ventricular filling pressure and the clinical presentations would be low blood pressure, poor peripheral perfusion, and pulmonary edema. Severe systolic heart failure with hemodynamically significant mitral regurgitation brings even more challenged since the obvious elevation of left atrial pressure induces more pulmonary congestion and backward flow of regurgitation in cases with already low cardiac output and poor peripheral perfusion complicates more severe of low cardiac output. Surgical interventions in those cases aren't strongly recommended due to very high operation risk. In the era of lack of nitroprusside in Taiwan (more than 7 years), hydralazine, a direct vasodilator, is a potential substitute for treatment of those cases. The advantages of hydralazine include 1) different dosage forms are available (10 mg, 25 mg, and 50 mg); 2) short half-life makes it reaching steady blood concentration in short period and allow to up- titrate rapidly and also recover fast while adverse reaction occurs; 3) it is much cheaper than other evidence-based medications. In this study, the investigators try to use rapid up-titration of hydralazine to maximal tolerable dose, almost up to 300-400 mg per day, combined with other evidence-based medications in cases with left ventricular ejection fraction less than 35% and mitral regurgitation severity more than moderate degree and assess the prognostic impact. Objective: Four hundred of patients with severe systolic dysfunction and hemodynamically significant mitral regurgitation, who were admitted for intensive care unit for acute decompensated heart failure, will be enrolled and the participants will be divided into two groups according 1 to 1 randomization process. Control group will receive conventional treatment with tolerable maximal dose of evidence-based medications and study group will use hydralazine with rapid up-titration, if no clinical adverse responses were noted, following by or simultaneously using evidence-based medications. The end-points include in- hospital mortality, 3-year all-cause mortality and heart failure rehospitalization. During follow-up period, any adverse response of high-dose hydralazine including lupus-like syndrome and arthritis will be monitored.

Start: August 2018

Percutaneous Mitral Valve Intervention: Predicting Improvements in Left Ventricular Performance

The purpose of this study is to assess the role of cardiac imaging combined with demographic, clinical, and biochemical parameters in predicting outcomes following percutaneous mitral valve intervention in order to facilitate more careful risk stratification, interventional planning and avoidance of high risk futile procedures.The principle objective of this study is to determine if transthoracic echocardiography (TTE) can predict changes in left ventricular (LV) size and function following percutaneous mitral valve intervention (PMVI).

Start: March 2019

Primary Mitral Regurgitation Repair

This longitudinal cohort study evaluates the relationship of myocardial tissue markers characteristics assessed by cardiac MRI, with clinical measures of symptoms and functions in adults with primary mitral regurgitation. Participants are followed conservatively or may choose to undergo surgical repair at the discretion of their clinical team.

Start: May 2018

The Effects of Degenerative Mitral Regurgitation on Cardiac Structure and Function, Symptoms, and Exercise Capacity

Current American College of Cardiology/American Heart Association guidelines recommend that patients with severe degenerative mitral regurgitation be considered for mitral valve surgery. There remains a debate within the cardiology community regarding the appropriate management of patients who remain asymptomatic. In this study the investigators will perform longitudinal follow-up data with cardiac MRI to inform the prophylactic surgery vs. close follow-up debate and to better define the natural history of this condition. The investigators hypothesize, that in the majority of patients mitral regurgitation will not worsen overtime, left ventricular hemodynamics will remain stable, exercise capacity will not decline, and symptoms will not worsen during follow-up. This finding would have a significant impact on the current recommendations for treatment in patients with mitral regurgitation by supporting a conservative management approach.

Start: August 2019

Effect of MitraClip on Acute and Chronic Reverse Cardiac Remodeling Assessed by CMR: The MITRA-REVERSE Study

The purpose of this study is to use cardiac magnetic resonance (CMR) and echocardiography to define the anatomic and functional remodeling that results from MitraClip implantation. A total of sixty (60) patients undergoing MitraClip implantation will be enrolled across multiple sites. The severity of mitral regurgitation, cardiac morphology and function will be assessed in these patients by taking cardiac magnetic resonance imaging with an FDA approved contrast agent at BASELINE (within 30 days prior to MitraClip implantation), during the ACUTE REMODELING PHASE (pre-discharge following implantation), and during the CHRONIC REMODELING PHASE (6 months post-implantation).

Start: January 2017