Clinical trials: Mitral Valve Repair, open to volunteers
Mitral Valve Repair Surgery
Safety and Effectiveness of Early Aspirin Administration After Mitral Valve Repair
This study compares the efficacy and safety of two different antithrombotic drugs, warfarin and aspirin, in early application after mitral valve repair (MVRep).
- Trial name
- NCT06738992
- Testing
- Aspirin, Warfarin
- Where
- China
- Volunteers
- 384 people
- Sponsor
- Guangdong Provincial People's Hospital
Mitral Regurgitation (MR)
Research on the Development and Application of a Preoperative Assessment Model for Transcatheter Mitral Valve Edge-to-Edge Repair Based on Visual Foundation Models
Mitral regurgitation (MR) is the most prevalent valvular heart disease in China. Transcatheter edge-to-edge repair (TEER) is currently the preferred treatment for patients with severe MR who face high surgical risks.
- Trial name
- NCT07247890
- Testing
- Model Construction, Validation, and Optimization
- Volunteers
- 800 people
- Sponsor
- Beijing Hospital
Mitral Regurgitation
Dutch-AMR: Early Mitral Valve Repair Versus Watchful Waiting in Asymptomatic Patients With Severe Mitral Regurgitation
Rationale: Severe asymptomatic organic Mitral Valve (MV) regurgitation with preserved left ventricular (LV) function is a challenging clinical entity as data on the recommended treatment strategy for these patients are scarce and…
- Trial name
- Dutch-AMR (NCT03975998)
- Testing
- Mitral valve repair
- Where
- 6 sites in Netherlands
- Volunteers
- 500 people
- Sponsor
- UMC Utrecht
Transcatheter Mitral Valve Edge-to-Edge Repair System, Biodegradable Patent Foramen Ovale Closure Device
Active Surveillance and Safety/Efficacy Evaluation of Innovative Devices for Structural Heart Disease Intervention
This study aims to establish an active surveillance system to evaluate the safety and effectiveness of innovative medical devices used in the interventional treatment of structural heart disease.
- Trial name
- ASSEE-SHD (NCT07848152)
- Where
- 11 sites in China
- Volunteers
- 2,200 people
- Sponsor
- Shanghai Jiao Tong University School of Medicine
Severe Mitral Valve Regurgitation (Disorder)
Transcatheter Versus Standard Surgical Mitral Valve Operation for Secondary Mitral Regurgitation
The mechanical intervention is treating secondary mitral regurgitation (SMR) which may be performed using the standard open surgical approach or transcatheter edge to edge repair (TEER).
- Trial name
- TEERMISO (NCT05090540)
- Testing
- Trancatheter Edge to Edge Repair, Mitral Valve Replacement, Restrictive Mitral Annuloplastie
- Where
- 2 sites in France
- Volunteers
- 600 people
- Sponsor
- Centre Cardiologique du Nord
Functional Mitral Regurgitation, Mitral Regurgitation
The CINCH-FMR Post-Market Registry: Percutaneous Repair in Functional Mitral Regurgitation
This is a retrospective and prospective, multi-center, post-market observational registry study. The primary objective of this post market registry is to continue to evaluate the long term safety and performance of the Carillon®…
- Trial name
- CINCH-FMR (NCT05677568)
- Testing
- Carillon Mitral Contour System
- Where
- 19 sites in Germany
- Volunteers
- 250 people
- Sponsor
- Cardiac Dimensions, Inc.
Mitral Regurgitation (MR)
The Prospective Segeberg Registry for Mitral Transcatheter Edge-to-Edge Repair
A Prospective Follow-up Assessment in Bad Segeberg for Patients with severe MR undergoing M-TEER
- Trial name
- SK M-CLIP (NCT07045753)
- Testing
- Transcatheter edge to edge repair
- Where
- Germany
- Volunteers
- 2,000 people
- Sponsor
- Segeberger Kliniken GmbH
Mitral Valve Insufficiency
The Half Moon Transcatheter Mitral Valve Repair (TMVr) Pilot Study
The study is a prospective, multi-center, single-arm, non-randomized, Early Feasibility Study (EFS) to evaluate the safety and performance of the Half Moon TMVr System in patients with severe, symptomatic mitral regurgitation…
- Trial name
- NCT04343313
- Testing
- Half Moon TMVr System
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Half Moon Medical
Degenerative Mitral Regurgitation
FIH ITA Study - Vesalius TMVr System for Symptomatic Degenerative Mitral Regurgitation
This first-in-human study evaluates the safety and performance of the Vesalius Transcatheter Mitral Valve Repair (TMVr) System in patients with degenerative mitral regurgitation.
- Trial name
- NCT07470788
- Testing
- Transcatheter Mitral Valve Repair
- Where
- Canada
- Volunteers
- 5 people
- Sponsor
- Vesalius Cardiovascular Inc.
Mitral Regurgitation
TEER for Severe DMR of Low to Intermediate Surgery Risk
To investigate the efficacy and safety of transcatheter mitral valve edge-to-edge repair (TEER) for severe degenerative mitral regurgitation (DMR) patients of low to intermediate surgery risk.
- Trial name
- NCT06162780
- Testing
- ultrasonic cardiography (UCG), TEER
- Where
- China
- Volunteers
- 160 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Functional Mitral Regurgitation, Heart Failure
The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMR
The objective of this prospective, randomized, double- blinded (patient and assessors), sham-controlled clinical trial is to assess the safety and efficacy of the CMCS in treating heart failure with functional regurgitation (FMR).
- Conditions
- Functional Mitral Regurgitation, Heart Failure, Mitral Valve Insufficiency, Heart Diseases
- Trial name
- NCT03142152
- Testing
- Carillon Mitral Contour System, Guideline Directed Heart Failure Medication
- Where
- 92 sites in United States, Canada and 6 more
- Volunteers
- 300 people
- Sponsor
- Cardiac Dimensions, Inc.
Mitral Regurgitation
Anchord Mitral Chordal Repair System - FIH
The goal of this clinical trial is to generate initial human clinical experience and evaluate procedural feasibility, device deployment, and early safety under controlled First-In-Human conditions for the Anchord Mitral Chordal…
- Trial name
- NCT07671820
- Testing
- Anchord device implantation
- Volunteers
- 5 people
- Sponsor
- Lifecord Otd
Mitral Valve (MV) Regurgitation
A Prospective, Multicenter, Single-Arm Study to Support the Clinical Evidence Base for MRace as a Treatment Option for FMR Patients With Complex M-TEER Anatomies (AU)
A pilot study to evaluate the safety and performance of the MRace System to treat severe mitral regurgitation and to gather data on its performance thereby providing guidance for future clinical development.
- Trial name
- ACCESS-MR (AU) (NCT07757698)
- Testing
- Transcatheter mitral valve repair
- Volunteers
- 15 people
- Sponsor
- Polares Medical SA
Aortic Aneurysm, Aortic Aneurysm Abdominal
Prophylactic Suture Line Sealing With NE'X Glue R-eco in Cardiac and Vascular Surgery
This clinical study aims to evaluate the effectiveness and safety of using NE'X Glue R-eco to seal suture lines. The adhesive will be applied to reduce the risk of suture line bleeding in cardiac or vascular repair surgeries, a…
- Conditions
- Aortic Aneurysm, Aortic Aneurysm Abdominal, Valve Stenoses, Aortic, Valve Regurgitation, Mitral
- Trial name
- CLOSURE (NCT06918496)
- Testing
- Surgical placement of a prosthetic or biologic graft (patch), or an allograft for cardiac and (cardio)vascular repair.
- Where
- 2 sites in Belgium, Poland
- Volunteers
- 60 people
- Sponsor
- Grena Biomed Limited
Mitral Valve Repair Surgery
Video-Based AI-Generated Peri-operative Instructions for Mitral Valve Surgery
1. The purpose of this study is to evaluate the impact of a novel, AI-generated, interactive peri-operative video education program on total unplanned healthcare utilization 2.
- Trial name
- VIP-IMPACT (NCT07036926)
- Testing
- Artificial Intelligence Video Education Arm
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Joanna Chikwe
Mitral Regurgitation
Outcome Registry and Assessment of New Edge-to-Edge Repair
The goal of this observational study is to learn about the long-term effects of Edge-tot-edge repair of all the patients of AmsterdamUMC, to treat their Mitral regurgitation (MR).
- Trial name
- ORANGE-TEER (NCT07108907)
- Where
- Netherlands
- Volunteers
- 300 people
- Sponsor
- Abby Geerlings
Mitral Regurgitation
MitraClip® Registry
Percutaneous mitral valve repair with the MitraClip® system has emerged as a therapeutic alternative to surgical valve repair (PMVR) in high risk patients.
- Trial name
- NCT02033811
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Klinik für Kardiologie, Pneumologie und Angiologie
Mitral Valve (MV) Regurgitation
A Prospective, Multicenter, Single-Arm Study to Support the Clinical Evidence Base for MRace as a Treatment Option for FMR Patients With Complex M-TEER Anatomies (FR)
A pilot study to evaluate the safety and performance of the MRace System to treat severe mitral regurgitation and to gather data on its performance thereby providing guidance for future clinical development.
- Trial name
- ACCESS-MR (FR) (NCT07757607)
- Testing
- Transcatheter mitral valve repair (MRace Implant and Delivery System)
- Volunteers
- 20 people
- Sponsor
- Polares Medical SA
Heart Valvular Disease
Multi-center Research Clinical Trial Protocol for Etiology-pathology and Repair Classification of Mitral and Tricuspid Valves
The choice of valve repair is very important in the treatment of cardiac valve disease, and its core is the etiology pathology analysis, which directly determines the design of repair strategy and the quality of postoperative…
- Trial name
- NCT07863531
- Testing
- Valve repair, Valve replacement
- Volunteers
- 200 people
- Sponsor
- Keli Huang
Mitral Regurgitation Functional
Safety and Effectiveness Study of Dragonfly System for Functional Mitral Regurgitation
To confirm the effectiveness and safety of the Dragonfly transcatheter mitral valve repair system for the treatment of chronic moderate to severe (3+) or severe (4+) functional mitral regurgitation (FMR) who remained clinically…
- Trial name
- NCT04733404
- Testing
- Dragonfly Transcatheter Mitral Valve Repair System
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Hangzhou Valgen Medtech Co., Ltd