Mitral Valve Prolapse

11

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

Condition / disease
Location
Status: Recruiting

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

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.

Participants needed: 60
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Universitaire Ziekenhuizen KU LeuvenUpdated: May 5, 2026Locations: 1
Eligibility criteria

Patients aged 18 years or older [+4]

Prior cardiac surgery, including previous mitral valve intervention [+6]

Status: Recruiting

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

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.

Participants needed: 300
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Centro Cardiologico MonzinoUpdated: Feb 3, 2026Locations: 1
Eligibility criteria

age ≥ 18 years [+1]

age< 18 years [+3]

Status: Recruiting

AI-Based Shape and Function Analysis of Mitral Valve Prolapse Using 3D Ultrasound

This study aims to develop and validate a fully automated imaging and modeling pipeline for the analysis of mitral valve prolapse (MVP) using real-time three-dimensional transesophageal echocardiography (RT3DE). The primary goal is to automatically segment mitral valve (MV) substructures, extract anatomical landmarks, and generate 3D models of the MV apparatus to characterize morphological and functional features of degenerative MVP. Advanced deep learning techniques and geometric processing tools will be applied to enable automated analysis. A secondary objective is to build patient-specific finite element (FE) models based on RT3DE data to evaluate the biomechanical consequences of MVP and to simulate the effects of surgical repair. These simulations will assess stress distribution and force transmission within the MV apparatus. Additionally, in cases where substantial surgical resection of MV tissue occurs, excised leaflet samples will be collected and preserved for histological and morphometric analysis.

Participants needed: 150
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: IRCCS Policlinico S. DonatoUpdated: Feb 3, 2026Locations: 1
Eligibility criteria

Adult patients (age > 18 years old); [+3]

Inadequate quality of 3DRTE imaging, e.g., due to inadequate patient-specific ac... [+2]

Status: Recruiting

Ventricular Arrhythmias in Patients Undergoing Mitral Valve Surgery

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

Participants needed: 90
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Karolinska InstitutetUpdated: Sep 11, 2025Locations: 1
Eligibility criteria

Age 18 and over [+1]

Secondary mitral regurgitation [+8]

Status: Recruiting

PRIMARY Ancillary Substudy

The PRIMARY trial (NCT05051033), which compares mitral valve repair (MVr) to transcatheter-edge-to-edge-repair (TEER), offers a platform for conducting mechanistic studies to develop early insights into the pathophysiological processes by which mitral valve prolapse (MVP) can impact left ventricular (LV) myocardial structure and function, and, thereby, predispose to arrhythmias and sudden death. Such insights are key to identifying interventions to reduce the long-term sequelae of heart failure (HF) and arrhythmias, as well as delineate optimal therapeutic approaches for different patient sub-groups.

Participants needed: 250
Trial details
Age: 60+Biological sex: AllType: InterventionalSponsor: Annetine GelijnsUpdated: Aug 19, 2025Locations: 25
Eligibility criteria

Patients who meet all eligibility criteria and are randomized in the parent PRIM... [+1]

Severe claustrophobia not controlled with sedation. [+3]

Status: Recruiting

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

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.

Participants needed: 50
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Oslo University HospitalUpdated: Jul 30, 2025Locations: 1
Eligibility criteria

Participants must be 18 years of age or older at the time of signing the informe... [+5]

Strict contraindications to flecainide or metoprolol use [+16]

Status: Not yet recruiting

Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice

Valvular heart disease (VHD) is a growing public health concern globally, with increasing disease burden and rising interest in advanced treatment strategies such as transcatheter interventions. However, there remains a significant lack of real-world data regarding echocardiography practices, disease prevalence and progression, referral patterns, and treatment pathways. Addressing these gaps is critical for improving patient care and informing clinical decision-making. South Korea provides a unique opportunity to conduct a nationwide retrospective echocardiographic study due to its advanced healthcare infrastructure, high patient volume, and strong tradition in clinical research. The current study aims to evaluate the real-world burden and clinical journey of patients with moderate or severe valvular disease over a 10-year period, based on echocardiographic and electronic medical record (EMR) data collected from multiple tertiary centers across the country.

Participants needed: 30,000
Trial details
Age: 19+Biological sex: AllType: ObservationalSponsor: Yonsei UniversityUpdated: Jul 16, 2025Locations: 1
Eligibility criteria

Period: 2010.1.1~2020.12.31 [+3]

Poor image of echocardiography [+1]

Status: Recruiting

Patient-Centered Approach for Treatment Decisions in Mitral Valve Prolapse

This is a qualitative and quantitative study that seeks to obtain information from patients with degenerative mitral valve prolapse and providers regarding factors important in deciding between surgical mitral valve repair (MVR) and transcatheter edge-to-edge repair (TEER). Findings from this study will provide data that can be used to develop decision aids that can assist patients in decision making between these two therapies and assist providers in integrating shared decision making the within the multidisciplinary heart valve team.

Participants needed: 150
Trial details
Age: 21+Biological sex: AllType: ObservationalSponsor: Northwell HealthUpdated: Dec 17, 2024Locations: 5
Eligibility criteria

Age 21 years and older [+1]

Non-English speaking [+2]

Status: Not yet recruiting

A Study of Mitral Annular Disjunction in Mitral Valve Prolapse Patients and Arrhythmia Risk

This study investigates the characteristics and prevalence of mitral annular disjunction in patients with mitral valve prolapse with severe mitral regurgitation (MR) at Assiut University Heart Hospital.

Participants needed: 30
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Assiut UniversityUpdated: Dec 19, 2024Locations: 1
Eligibility criteria

All consecutive patients > 18 years of age presenting to Assiut University Heart...

Previous mitral valve surgery. [+3]

Status: Recruiting

Prognostic Impact of the Location of Mitral Valve Prolapse on the Long-term Results of Mitral Plasty

Mitral insufficiency (MI) accounts for 24% of adult valvulopathies and affects 7% of subjects older than 75 years. They are the second leading cause of valvulopathy in Europe. The most common etiology is the associated valvular prolapse. Mitral surgery remains the reference treatment for symptomatic MI. The success of this procedure depends on the mitral valve geometry and the location of the prolapse. The site of the prolapse, whether monovalvular, localized to the posterior or anterior leaflet, or bivalvular, influences the possibilities and probably the long-term results of the plasty.

Participants needed: 1,500
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Centre Hospitalier Universitaire, AmiensUpdated: May 23, 2023Locations: 1
Eligibility criteria

Patients operated between 1988 and 2011 [+2]

Ischemic MI (including papillary muscle rupture) [+2]

Status: Recruiting

Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System

The objective of this study is to evaluate the 5-year outcomes of participants with degenerative mitral valve disease treated with the NeoChord Artificial Chordae System, Model DS1000 in a post-market setting.

Participants needed: 500
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: NeoChordUpdated: Jul 10, 2020Locations: 5Duration: 5 Years
Eligibility criteria

Has Grade III Moderate or Grade IV Severe degenerative or mixed disease mitral v... [+1]

Heavily calcified valves [+5]