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Mitral Valve Prolapse clinical trials

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NCT ID: NCT06436573 Not yet recruiting - Clinical trials for Mitral Valve Disorder

Mitro-annular Disjunction in Cardiac Magnetic Resonance

Start date: June 2024
Phase:
Study type: Observational

Mitral annular disjunction (MAD) is an abnormal atrial displacement of the mitral valve leaflet hinge point. MAD is gaining clinical importance for several studies reporting its association to mitral valve prolapse (MVP), complex ventricular arrhythmias and sudden cardiac death. On the other hand, other studies found MAD as an extremely diffuse anatomical variant of mitral valve annulus without any pathological implication. Cardiac Magnetic Resonance is the non-invasive gold standard for myocardial characterization, with the possibility of accurate anatomical and functional evaluation associated to the evaluation of focal and interstitial fibrosis, resulting useful in the identification of arrhythmic substrate and for patients risk stratification. Additionally, Cardiac Magnetic Resonance (CMR) was found to be superior to echocardiography not only in term of tissue characterization, but also in the identification of small MAD. Therefore, in relation to the scarcity of data about MAD prevalence and pathological potential, we set a large multicenter retrospective study aimed to evaluate prevalence of MAD in patients submitted to CMR independently by the clinical suspicion, and to evaluate the association with prolapse and arrhythmias.

NCT ID: NCT06378996 Recruiting - Clinical trials for Ventricular Arrythmia

Arrhythmic Mitral Valve Prolapse Detection Using Long-term Ambulatory Rhythm Monitoring

ALARM-PILOT
Start date: May 2024
Phase: N/A
Study type: Interventional

Mitral valve prolapse (MVP) affects up to 3% of the general population and a small subset of patients is at risk for ventricular arrhythmias. This subgroup is referred to as AMVP (arrhythmic MVP) and was recently defined using the following criteria: (1) Presence of MVP), (2) Ventricular arrhythmia that is either frequent (≥5% total premature ventricular contraction (PVC) burden on Holter) or complex (non-sustained ventricular tachycardia (nsVT), ventricular tachycardia (VT), or ventricular fibrillation (VF)), and (3) The absence of any other well-defined arrhythmic substrate. Currently, diagnosis is often based on repeated 24-hour Holter monitoring. However, the ventricular arrhythmia burden varies from day-to-day and long-term rhythm monitoring has shown in other pathologies to increase the diagnostic yield with up to 200% (from 22.5% on 24h to 75.3% on 14 days). This pilot study aims to study the diagnostic yield of long-term rhythm monitoring in patients with MVP as well as the day-to-day variability of ventricular arrhythmias to facilitate power calculation for a future large-scale prospective registry.

NCT ID: NCT06341166 Recruiting - Clinical trials for Mitral Valve Prolapse

Multiparametric SCores for Prediction of Myocardial fIbrosis in Patients With MITral vAlve pRolapse

SCIMITAR
Start date: June 19, 2023
Phase:
Study type: Observational

This is a multicenter, observational prospective and retrospective study which aims are: 1) to compute a scoring model potentially predictive for the diagnosis of fibrosis by CMR in patients with MVP; 2) to identify specific features that may predispose to ≥ mild VAs or SCD in patients with MVP.

NCT ID: NCT06255457 Recruiting - Clinical trials for Ventricular Tachycardia

Ventricular Arrhythmias in Patients Undergoing Mitral Valve Surgery

Mitra-VT
Start date: February 21, 2024
Phase:
Study type: Observational

Study objectives: - To assess the impact of mitral valve surgery for mitral regurgitation on ventricular arrhythmic burden and surrogate markers of fibrosis in patients with arrhytmogenic mitral valve prolapse (MVP) from baseline to 6 months after surgery - To characterize the molecular landscape of arrhytmogenic MVP Study design: -Prospective explorative observational study Study population: -90 patients with arrhytmogenic MVP and without arrhytmogenic MVP (controls) eligible for mitral valve surgery for mitral regurgitation will be enrolled. All patients will be evaluated with cardiac magnetic resonance (CMR) imaging and continuous seven day arrhythmic monitoring before and at 6 months after mitral valve surgery

NCT ID: NCT05631730 Recruiting - Clinical trials for Mitral Valve Prolapse

Effect and Safety of Flecainide and Metoprolol Versus Metoprolol Alone to Suppress Ventricular Arrhythmias in Arrhythmic Mitral Valve Prolapse

FLECAPRO
Start date: January 4, 2023
Phase: Phase 3
Study type: Interventional

FLECAPRO is a randomized controlled crossover trial assessing the effect and safety of adding flecainide to standard beta-blocker therapy to reduce the burden of ventricular arrhythmias in patients with arrhythmic mitral valve prolapse. The primary endpoint of will be assessed using an implantable loop recorder with blinded endpoint adjudication.

NCT ID: NCT05562804 Recruiting - Cardiac Arrhythmia Clinical Trials

Mitral Valve Prolapse, Arrhythmias and Mitral Valve Surgery

MVP-A&S
Start date: February 10, 2021
Phase:
Study type: Observational [Patient Registry]

Mitral valve prolapse (MVP) is associated with malignant ventricular arrhythmias (VA) and sudden cardiac death. A proper electrophysiological and echocardiographic characterization of this population is missing. Moreover, the effects of mitral valve repair on the arrhythmic burden are still matter of debate. The investigators sought to explore the role of the arrhythmic substrate in the risk stratification of patients with MVP and to assess whether mitral surgery is followed by a significant modification of the baseline arrhythmic pattern.

NCT ID: NCT05425628 Not yet recruiting - Clinical trials for Cardiovascular Diseases

European FIH Study - NeoChord Transcatheter Mitral Repair System for Symptomatic Mitral Regurgitation

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

Safety and performance evaluation of the NeoChord Transcatheter Mitral Repair System in patients with degenerative mitral valve regurgitation.

NCT ID: NCT05284058 Recruiting - Clinical trials for Regurgitation, Mitral

Impact of Preoperative Myocardial Fibrosis Related to Mitral Valve Prolapse on Postoperative Left Ventricular Remodeling

IMPARED
Start date: June 28, 2022
Phase: N/A
Study type: Interventional

Primary mitral regurgitation (MR) is the most common valvular disease in western countries. The MR mechanism is often related to a mitral valve prolapse (MVP) defined as a single or bi-leaflet prolapse of at least 2 mm beyond the long-axis mitral annular plane. In recent years, several studies have identified a subtype of MVP patients at higher risk of ventricular arrhythmias (VA) and sudden cardiac death (SCD). The presence of regional myocardial replacement fibrosis (RMRF) has been shown as a risk marker of arrhythmic events (VA and SCD) in patients with MVP. RMRF can be identified using cardiac magnetic resonance (CMR) imaging with late gadolinium enhancement (LGE+). In these patients, fibrosis was found in the basal inferolateral myocardium and at the level of papillary muscles (PMs). This fibrosis is developed beyond the volume overload related to the MVP. It is probably linked to the mechanical stretch acting upon the valve and the neighboring left ventricle (LV) myocardium. RMRF is associated with a high degree of MR, with specific features of mitral valve apparatus (bi-leaflet prolapse with marked leaflet redundancy, mitral annulus abnormalities (i.e. Mitral-Annular Disjunction)), and more dilated LV. It is also independently associated with the occurrence of cardiovascular events. Mitral valve repair (MVr) is the gold standard treatment for primary Mitral Regurgitation. Very little data concerning the impact of preoperative RMRF on mitral valve surgery outcomes is available, and the impact of myocardial fibrosis on the postoperative left ventricle remodeling has not been studied so far. No previous study compares preoperative and postoperative fibrosis evolution. Thus, no data exists regarding the postoperative evolution of this fibrosis and its relationship with ventricular arrhythmic risk after valve surgery. Small observational studies have suggested that mitral valve surgery did not reduce the risk of ventricular arrhythmias in patients with bileaflet MVP. Finally, the mechanisms involved in the development of regional myocardial replacement fibrosis within the left ventricle myocardium during the natural history of MVP cannot be understood with current standard medical imaging tools. Numerical simulation technologies provide an innovative and in-vivo approach to assess the physical and pathological mechanisms causing this fibrosis. They can also be used to assess the changes in mitral valve and myocardium dynamics after surgical mitral valve repair procedures. A large consortium, involving physicians and scientists, has been created to address these questions to fulfil our objectives over a 4 year period (SIMR project).

NCT ID: NCT04852731 Recruiting - Clinical trials for Mitral Valve Prolapse

STretch and Myocardial Characterization in Arrythmogenic Mitral Valve Prolapse-2

STAMP-2
Start date: August 30, 2021
Phase: N/A
Study type: Interventional

Mitral valve prolapse (MVP) is a frequent affection of the mitral valve with a prevalence of 2-3% in the general population. This valvular disease is generally considered as benign, but may at term evolve toward mitral valve regurgitation of various severity and/or arrhythmia. Mitral valve prolapse is routinely diagnosed using transthoracic echocardiography. Subsequent examinations (24-hour external loop recording, exercise electrocardiogram, cardiac Magnetic Resonance Imaging) and a close follow-up can be proposed to the patient depending on its condition. More recently, detection of myocardial fibrosis and a mitral ring disjunction among patients with MVP were associated with the occurrence of severe ventricular arrhythmia. The investigators hypothesize that ventricular remodeling over time is mediated by the progression of mitral insufficiency severity from myocardial fibrosis secondary to MVP and possibly promoted by other mitral valve abnormalities. This remodeling, characterized by circulating biomarkers and imaging (MRI and echocardiography), could allow the identification of patients with a higher risk of severe ventricular arrhythmia. The main objective of this study is to identify prognostic factors for unfavorable evolution (ventricular remodeling or a rhythm disorder event) at 3 years from initial assessments in MVP patients.

NCT ID: NCT04770961 Not yet recruiting - Clinical trials for Mitral Regurgitation

Erector Spinae Plane Block for Minimally Invasive Mitral Valve Surgery

Start date: April 1, 2021
Phase: N/A
Study type: Interventional

The goal of this project is to study whether local anesthetic via the erector spinae plane (ESP) block may be beneficial in minimally invasive mitral valve surgery (MIMVS).