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Mitral Valve Insufficiency clinical trials

View clinical trials related to Mitral Valve Insufficiency.

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NCT ID: NCT05506293 Recruiting - Quality of Life Clinical Trials

European Multicentre Registry of Percutaneous Paravalvular Leak Closure

EuroPVL
Start date: January 1, 2020
Phase:
Study type: Observational [Patient Registry]

Paraprosthetic cardiac valve leaks are a progressive complication after after surgical or percutaneous heart valve replacement. These leaks can lead to heart failure and/or life-threatening hemolysis. Percutaneous closure of para-prosthetic leaks has been developed as an alternative to surgery in high-risk patients. These procedures remain technically challenging with a significant risk of failure and complications, but this risk is improved since the development of dedicated prostheses and the increased experience of the operators. The data in the literature concerning percutaneous leak closure remain limited and disparate and mostly retrospective.The impact of the procedures on the quality of life of patients is not known. Beyond the technical aspects and the follow-up of major cardiovascular events, investigators also wonder what is the impact of these procedures on the quality of life of patients. Investigators hypothesize that even a partial reduction in paraprosthetic leakage may be associated with an improvement in quality of life through reduction of transfusion needs and/or reduction of dyspnea. A prospective study is warranted to assess the technical and clinical and clinical results of these procedures, together with the evaluation of the the possible benefit on the quality of life of the patients.

NCT ID: NCT05496998 Recruiting - Clinical trials for Mitral Regurgitation

Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial

APOLLO-EU
Start date: February 7, 2023
Phase: N/A
Study type: Interventional

Evaluate the safety and efficacy of Medtronic Intrepid™ TMVR TF System in patients with moderate-to-severe or severe symptomatic mitral regurgitation, or moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of MAC who, by agreement of the local site multidisciplinary heart team experienced in mitral valve therapies, are unsuitable for treatment with approved transcatheter repair or surgical mitral valve intervention.

NCT ID: NCT05469165 Recruiting - Clinical trials for Ischemic Mitral Regurgitation

Serotonin Receptor Blockers in Ischemic Mitral Regurgitation

CYPRO-MR
Start date: June 20, 2023
Phase: Phase 2
Study type: Interventional

This study is intended to investigate the effect of cyproheptadine (a 5HT2B receptor blocker) on mitral regurgitation severity.

NCT ID: NCT05455489 Recruiting - Clinical trials for Mitral Valve Regurgitation

GISE Registry of Transcatheter Treatment of Mitral Valve Regurgitation With the MitraClip G4

Start date: January 25, 2023
Phase:
Study type: Observational [Patient Registry]

The aim of the GISE study is to confirm the MitraClip safety and improve the device effectiveness in a selected all comers ("more-comers") population with symptomatic severe mitral regurgitation undergoing/undergone Transcatheter Edge-to-Edge Repair (TEER) with MitraClip G4.

NCT ID: NCT05374733 Recruiting - Clinical trials for Coronary Artery Disease

Coronary Physiology Peri-Transcatheter Left-sided Valvular Interventions

POTUS
Start date: March 22, 2021
Phase: N/A
Study type: Interventional

Prospective, single-arm, observational study with invasive coronary physiology measurements before and after transcatheter left-sided valvular intervention.

NCT ID: NCT05345730 Recruiting - Surgery Clinical Trials

The Role of Left Atrial Fibrosis in Mitral Valve Repair Surgery (ALIVE Trial)

ALIVE
Start date: February 2, 2022
Phase:
Study type: Observational

Rationale: Patients with mitral valve insufficiency suffer from left atrial remodeling. Atrial fibrosis is part of this remodeling process. The presence of atrial fibrosis is associated with adverse events. Currently, mitral valve repair surgery is the ultimate treatment for severe primary mitral valve insufficiency. The main indications and timing for surgery are severe mitral valve insufficiency with symptoms or left ventricular dysfunction. However, the role of atrial fibrosis in this process remains undetermined despite its well-recognized clinical implications. Characterization of atrial fibrosis patterns in mitral valve insufficiency patients might be potentially valuable for the indication and timing of mitral valve repair surgery in order to improve clinical outcomes. To date, however, mitral valve insufficiency patients suffering from left atrial remodeling have hardly been studied using these new imaging techniques. Therefore, the investigators intend to combine advanced cardiac MRI and post-processing techniques prior to and after mitral valve repair surgery to gain more insight in the clinical implications of atrial fibrosis in this patient population. It is hypothesized that the atrial fibrosis surface area paradoxically will increase after mitral valve surgery because of global shrinkage of the left atrium caused by the reversed remodeling process. As a consequence, more frequently atrial fibrosis related events including (paroxysmal) atrial fibrillation, may be observed in these patients. Objective: To assess the effects of (reduced) volume overload on the left atrial wall texture (presence, amount and location of atrial fibrosis) and associated geometry and function in patients with mitral valve insufficiency, prior to and after mitral valve repair surgery. Study design: Single center pilot study. Study population: The research population consists of mitral valve insufficiency patients scheduled for elective surgical mitral valve repair (N=20) according to the current European guideline criteria.

NCT ID: NCT05332782 Recruiting - Clinical trials for Mitral Regurgitation

Outcomes of Patients tReated wIth Mitral Transcatheter Edge-to-edge Repair for Primary Mitral Regurgitation Registry

PRIME-MR
Start date: March 1, 2022
Phase:
Study type: Observational

This multinational, non-interventional, investigator-initiated, retrospective study aims to investigate outcomes of patients, who underwent mitral valve transcatheter edge-to-edge repair (M-TEER) for primary mitral regurgitation (PMR).

NCT ID: NCT05311163 Recruiting - Clinical trials for Mitral Regurgitation

Change in LVEF Following Transcatheter Mitral Edge-To-Edge Repair

MITRA-EF
Start date: August 1, 2021
Phase:
Study type: Observational [Patient Registry]

Little is known regarding the impact of transcatheter mitral valve edge-to-edge repair (TEER) on the acute changes in left ventricular ejection fraction (LVEF) and the effect of an acute reduction in LVEF, the so-called "afterload mismatch" (AM), on prognosis. We thereby aim to assess changes in LVEF after TEER, identify rate and predictors AM, and estimate its impact on prognosis.

NCT ID: NCT05310461 Recruiting - Clinical trials for Aortic Valve Replacement in Patients With Moderate Aortic Stenosis Combined With Mitral Regurgitation

Early Versus Deferred Aortic Valve Replacement in Patients With Moderate Aortic Stenosis and Mitral Regurgitation

TIAMAR
Start date: August 17, 2022
Phase: N/A
Study type: Interventional

The aim of the present study is to investigate safety and efficacy of early versus deferred aortic valve replacement in patients with moderate aortic stenosis combined with moderate mitral regurgitation.

NCT ID: NCT05298124 Recruiting - Clinical trials for Mitral Regurgitation

Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock

MINOS
Start date: May 26, 2022
Phase: N/A
Study type: Interventional

Mitral regurgitation may be seen in the setting of cardiogenic shock. Transcatheter edge-to-edge repair (TEER) has been shown to improve outcomes in patients with chronic heart failure. Observational studies suggest improvements in clinical outcomes in patients with mitral regurgitation in the setting of cardiogenic shock; however, there remains a lack of randomized clinical data to support the use of TEER in cardiogenic shock. This study will be a multicenter, open-label, randomized-controlled trial with two study arms: medical therapy and TEER. Patients admitted to the Cardiac Intensive Care Unit (CICU), Cardiac Surgery Intensive Care Unit (CSICU) or Intensive Care Units (ICU) at participating centers will be recruited. The study aims to answer the question: "Does TEER in patients with SCAI stage C or D cardiogenic with concomitant moderate or greater mitral regurgitation improve outcomes as compared to medical therapy?" The study hypothesis is that TEER will lead to an overall improvement in the composite outcome as compared to the medical therapy arm.