Clinical trials: Mitral Valve Prolapse
Mitral Valve Insufficiency, Heart Valve Diseases
NeoChord TACT Post-Market Surveillance Registry
To monitor the long-term performance of the CE Marked NeoChord Artificial Chordae Delivery System
- Conditions
- Mitral Valve Insufficiency, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases
- Trial name
- NCT01784055
- Where
- 7 sites in France, Germany and 3 more
- Volunteers
- 126 people
- Sponsor
- NeoChord
Mitral Valve Prolapse
STretch and Myocardial Characterization in Arrythmogenic Mitral Valve Prolapse-2
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…
- Trial name
- STAMP-2 (NCT04852731)
- Testing
- Cardiac MRI, Blood collection, Prolongation of the MRI examination
- Where
- France
- Volunteers
- 280 people
- Sponsor
- Central Hospital, Nancy, France
Non-ischemic Cardiomyopathy, Dilated Cardiomyopathy (DCM)
Multimodal and Multidisciplinary Approach to Optimize Diagnostic, Prognostic, and Therapeutic Management of Patients with Non-ischemic Cardiomyopathies and Arrhythmogenic-inflammatory Phenotypes: a Multicenter, Observational, Retrospective and Prospective Registry Study.
Non-ischemic cardiomyopathies (NICM) represent a heterogeneous group of pathologies characterized by absence of obstructive disease of the epicardial coronary vessels and distinct structural and functional changes of the…
- Conditions
- Non-ischemic Cardiomyopathy, Dilated Cardiomyopathy (DCM), Hypertrophic Cardiomyopathy (HCM), Restrictive Cardiomyopathy
- Trial name
- AINICM (NCT06607471)
- Testing
- Support treatment, cardiac medical treatment, aetiology-specific treatment, device implant, arrhythmia ablation, Support treatment, cardiac medical treatment, aetiology-specific treatment
- Where
- Italy
- Volunteers
- 15,000 people
- Sponsor
- Scientific Institute San Raffaele
Mitral Valve Prolapse, Mitral Regurgitation
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.
- Trial name
- NCT04299334
- Testing
- adjustable neochordae Technique
- Where
- Egypt
- Volunteers
- 30 people
- Sponsor
- National Heart Institute, Egypt
Barlow's Disease, Prolapse; Mitral
Minimally Invasive or Conventional Edge-To-Edge Repair for Severe Mitral Regurgitation Due to Bileaflet Prolapse in Barlow's Disease: Does the Surgical Approach Have an Impact on the Long-term Results?
The study evaluates the long-term results of patients affected by bileaflet prolapse in Barlow's Disease, treated with edge-to-edge technique between 1997 and 2011.
- Trial name
- NCT04002648
- Testing
- Right minithoracotomy, Sternotomy
- Volunteers
- 208 people
- Sponsor
- Ospedale San Raffaele
Mitral Valve Regurgitation
Safety and Performance Study of the NeoChord Device
The purpose of this study is to demonstrate the safety and performance of the NeoChord DS1000 Artificial Chordae Delivery System in implanting ePTFE sutures(s) as artificial neochordae in patients with mitral regurgitation.
- Trial name
- TACT (NCT01777815)
- Testing
- NeoChord DS1000 Artificial Chordae Delivery System
- Where
- 8 sites in Denmark, Germany and 2 more
- Volunteers
- 30 people
- Sponsor
- NeoChord
Mitral Valve Prolapse, Ventricular Arrhythmias and Cardiac Arrest
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…
- Trial name
- FLECAPRO (NCT05631730)
- Testing
- Flecainide, Metoprolol
- Where
- Norway
- Volunteers
- 50 people
- Sponsor
- Oslo University Hospital
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 Insufficiency, Mitral Valve Prolapse
European FIH Study - NeoChord Transcatheter Mitral Repair System for Symptomatic Mitral Regurgitation
Safety and performance evaluation of the NeoChord Transcatheter Mitral Repair System in patients with degenerative mitral valve regurgitation.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Prolapse, Degenerative, Mitral Regurgitation
- Trial name
- NCT05425628
- Testing
- NeoChord Transcatheter Mitral Repair System (or "NeoChord System")
- Volunteers
- 30 people
- Sponsor
- NeoChord
Mitral Valve Regurgitation, Mitral Valve Prolapse
Safety and Early Feasibility Study of the Harpoon Medical Device (EFS)
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
- EFS (NCT02771275)
- Testing
- Harpoon Medical Device
- Where
- 2 sites in Poland
- Volunteers
- 13 people
- Sponsor
- Edwards Lifesciences
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 Regurgitation
Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY)
This is a prospective, multicenter, open-label, randomized trial comparing mitral valve (MV) transcatheter edge-to-edge repair (TEER) to surgical repair (1:1 ratio) in patients with primary, degenerative mitral regurgitation…
- Trial name
- PRIMARY (NCT05051033)
- Testing
- Mitral valve repair, Transcatheter edge-to-edge repair
- Where
- 67 sites in United States, Canada and 3 more
- Volunteers
- 450 people
- Sponsor
- Annetine Gelijns
Heart Murmurs, Mitral Valve Prolapse
Automatic Differentiation of Innocent and Pathologic Murmurs in Pediatrics
The purpose of this preliminary clinical study is to assess the quality of a computational algorithm that automatically classifies murmurs of phonocardiograms (PCGs) as either pathologic (AHA class I) or as no- or innocent (AHA…
- Conditions
- Heart Murmurs, Mitral Valve Prolapse, Systolic Murmurs
- Trial name
- NCT02512341
- Testing
- Computer Aided Auscultation (CAA)
- Where
- Canada
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- CSD Labs GmbH
Heart Valve Diseases, Aortic Valve Stenosis
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.
- Conditions
- Heart Valve Diseases, Aortic Valve Stenosis, Aortic Valve Insufficiency, Mitral Valve Insufficiency
- Trial name
- NCT07068633
- Where
- South Korea
- Volunteers
- 30,000 people
- Sponsor
- Yonsei University
Mitral Valve Insufficiency, Mitral Valve Regurgitation
Feasibility Study of a Percutaneous Mitral Valve Repair System.
Prospective, multi-center, Phase I study of the Evalve Cardiovascular Valve Repair System (CVRS) in the treatment of mitral valve regurgitation. Patients will undergo 30-day, 6 month, 12 month, and 5 year clinical follow-up.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation
- Trial name
- EVEREST(I) (NCT00209339)
- Testing
- Percutaneous mitral valve repair (MitraClip Implant)
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- Abbott Medical Devices
Mitral Valve Prolapse, Cardiac Arrhythmia
Mitral Valve Prolapse, Arrhythmias and Mitral Valve Surgery
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.
- Trial name
- MVP-A&S (NCT05562804)
- Where
- Italy
- Volunteers
- 200 people
- Sponsor
- Ospedale San Raffaele
Mitral Valve Regurgitation, Mitral Valve Prolapse
CE Mark Study for the Harpoon Medical Device
The purpose 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 including: 1) a…
- Conditions
- Mitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency
- Trial name
- TRACER (NCT02768870)
- Testing
- Harpoon Artificial ePTFE Chords
- Where
- 4 sites in Italy, United Kingdom
- Volunteers
- 26 people
- Sponsor
- Edwards Lifesciences
Mitral Leaflet Prolapse
V-Chordal Adjustable System for Chordal Replacement in Mitral Valve Insufficiency Due to Leaflet Prolapse
The V-Chordal System is a new technology for mitral repair. The Valtech V-Chordal system, consists in the ability to adjust (elongate or shorten) the neochordae "off-pump" to achieve an optimal coaptation.
- Trial name
- NCT01415947
- Testing
- V Chordal
- Where
- Italy
- Volunteers
- 5 people
- Sponsor
- Edwards Lifesciences