Clinical trials: Mitral Leaflet Prolapse
Severe Degenerative Mitral Regurgitation Due to Mid-segment Posterior Leaflet Prolapse
Observational Registry on the HARPOON Device
To collect data on the HARPOON™ Mitral Valve Repair System for use in patients with severe degenerative mitral regurgitation due to posterior leaflet prolapse.
- Trial name
- REPLICATE (NCT04393779)
- Testing
- HARPOON Beating Heart Mitral Valve Repair System (MVRS)
- Where
- 7 sites in Germany, Spain and 1 more
- Volunteers
- 26 people
- Sponsor
- Edwards Lifesciences
Mitral Regurgitation, Mitral Valve Prolapse
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…
- Conditions
- Mitral Regurgitation, Mitral Valve Prolapse, Ventricular Tachycardia
- Trial name
- Mitra-VT (NCT06255457)
- Testing
- Mitral valve surgery
- Where
- Sweden
- Volunteers
- 90 people
- Sponsor
- Karolinska Institutet
Mitral Regurgitation, Mitral Valve Disease
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.
- Conditions
- Mitral Regurgitation, Mitral Valve Disease, Mitral Valve Insufficiency, Mitral Valve Prolapse
- Trial name
- AcChord (NCT04190602)
- Testing
- NeoChord Artificial Chordae Delivery System, Model DS1000
- Where
- 5 sites in Germany, Greece and 1 more
- Volunteers
- 500 people
- Sponsor
- NeoChord
Mitral Valve Prolapse, Ventricular Arrythmia
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.
- Trial name
- ALARM-PILOT (NCT06378996)
- Testing
- 14-day rhythm monitoring
- Where
- Belgium
- Volunteers
- 60 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Mitral Valve Regurgitation, Mitral Valve Prolapse
CE Mark Study for the Harpoon Medical Device in Poland
The purpose of this study is to evaluate the safety and performance of the Harpoon Medical TSD-5. The Harpoon device will provide many significant advantages over current surgical interventions including: 1) a small minimally…
- Conditions
- Mitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency
- Trial name
- NCT02432196
- Testing
- Harpoon Medical Device
- Where
- 2 sites in Poland
- Volunteers
- 26 people
- Sponsor
- Edwards Lifesciences
Mitral Valve Prolapse, Mitral Valve Insufficiency
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.
- Trial name
- NCT06741709
- Where
- Egypt
- Volunteers
- 30 people
- Sponsor
- Assiut University
Mitral Valve Prolapse
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…
- Trial name
- SCIMITAR (NCT06341166)
- Where
- Italy
- Volunteers
- 300 people
- Sponsor
- Centro Cardiologico Monzino
Mitral Valve Insufficiency, Mitral Valve Regurgitation
EVEREST II Pivotal Study High Risk Registry (HRR)
Prospective, multi-center, single arm registry. Clinical follow-up at discharge, 30 days, 6, 12, 18 and 24, months, and 3, 4 and 5 years.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation
- Trial name
- HRR (NCT01940120)
- Testing
- Percutaneous mitral valve repair using MitraClip implant
- Where
- 2 sites in United States
- Volunteers
- 78 people
- Sponsor
- Abbott Medical Devices
Mitral Valve Prolapse
Myocardial Characterization of Arrhythmogenic Mitral Valve Prolapse (STAMP: STretch and Myocardial Characterization in Arrhythmogenic Mitral Valve Prolapse)
Mitral valve prolapse (MVP) is a frequent affection of the mitral valve or its sub-valvular apparatus with a prevalence of 2-3% in the general population.
- Trial name
- STAMP (NCT02879825)
- Testing
- Cardiac MRI
- Where
- France
- Volunteers
- 239 people
- Sponsor
- Central Hospital, Nancy, France
Mitral Valve Regurgitation, Mitral Valve Prolapse
Safety and Performance Study of the Harpoon Mitral Valve Repair System
The primary objective of this study is to evaluate the safety and performance of the Harpoon Medical Device. It is anticipated, that the Harpoon Medical Device will provide advantages over current surgical interventions…
- Conditions
- Mitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency
- Trial name
- NCT03285724
- Testing
- Harpoon Artificial ePTFE Chords
- Where
- 2 sites in Poland
- Volunteers
- 1 people
- Sponsor
- Edwards Lifesciences
Mitral Valve Prolapse
St. Jude Medical Percutaneous Mitral Valve Repair Study
The purpose of this proof-of-concept study is to assess the relative safety and feasibility of the SJM Percutaneous Mitral Valve Repair (PMVr) Device.
- Trial name
- SJM PMVr (NCT01500148)
- Testing
- PMVr procedure (SJM Percutaneous Mitral Valve Repair (PMVr)
- Where
- United Kingdom
- Volunteers
- 2 people
- Sponsor
- Abbott Medical Devices
Mitral Valve Prolapse
Genetic Basis of Mitral Valve Prolapse
The investigators have successfully identified two novel genetic loci for MVP on chromosomes 11 and 13 and are searching for altered genes in these regions.
- Trial name
- MVP (NCT01719211)
- Where
- United States
- Volunteers
- 1,500 people
- Sponsor
- Massachusetts General Hospital
Mitral Valve Prolapse, Mitral Plasty
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.
- Trial name
- IPPVM (NCT03113552)
- Where
- France
- Volunteers
- 1,500 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Mitral Valve Disease
Evaluation of the Elasticity of the Mitral Valve
There is no information in the literature on the mechanobiological characteristics of mitral valve chords in living humans. All examinations were carried out on tissues taken from animals, either from cadavers or from frozen…
- Trial name
- NCT06153563
- Testing
- Data collection on patient history and intraoperative results.
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
Mitral Valve Prolapse, Left Ventricular Fibrosis
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…
- Conditions
- Mitral Valve Prolapse, Left Ventricular Fibrosis, Ventricular Arrhythmias
- Trial name
- NCT07103733
- Testing
- Cardiac Magnetic Resonance Imaging, ZioPatch Monitoring, Myocardial Tissue Biopsy
- Where
- 25 sites in United States, Germany and 1 more
- Volunteers
- 250 people
- Sponsor
- Annetine Gelijns
Mitral Regurgitation, Mitral Valve Insufficiency
Erector Spinae Plane Block for Minimally Invasive Mitral Valve Surgery
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).
- Conditions
- Mitral Regurgitation, Mitral Valve Insufficiency, Mitral Valve Prolapse
- Trial name
- NCT04770961
- Testing
- Erector spinae plane catheter with 0.5% Ropivacaine, Erector spinae plane catheter with saline
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of California, San Francisco