Clinical trials: Transcatheter Mitral Valve Edge-to-Edge Repair System
Heart Valve Disease, Mitral Valve (MV) Regurgitation
Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease
The objective of this study is to evaluate and predict the progression of moderate cardiac valve stenosis and regurgitation using clinical, biological, echocardiographic, computed tomography (CT), and magnetic resonance imaging…
- Conditions
- Heart Valve Disease, Mitral Valve (MV) Regurgitation, Mitral Valve Disease, Mitral Valve Stenosis
- Trial name
- VALVE-COMPASS (NCT07267117)
- Where
- 15 sites in China
- Volunteers
- 10,000 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Evaluate the Safety and Efficacy of the ValveClamp
Multi-center Trial of ValveClamp
The ValveClamp (Hanyu Medical Technology, Shanghai, China) is the first edge-to-edge mitral valve repair system for interventional operation in China, which is composed of the front clamp, the rear clamp and the closed ring.
- Trial name
- CLAMP (NCT03869164)
- Testing
- ValveClamp
- Where
- China
- Volunteers
- 110 people
- Sponsor
- Shanghai Zhongshan Hospital
Sleep-disordered Breathing (SDB), Aortic Valve Stenosis
Impact of Transcatheter Aortic Valve Implantation and Mitral Valve Repair on Sleep-Disordered Breathing
This prospective observational study aims to investigate the impact of transcatheter aortic valve implantation (TAVI) and transcatheter mitral valve edge-to-edge repair (M-TEER) on sleep-disordered breathing (SDB) in patients…
- Conditions
- Sleep-disordered Breathing (SDB), Aortic Valve Stenosis, Mitral Valve Regurgitation
- Trial name
- SLEEP-VALVE (NCT07520656)
- Where
- Greece
- Volunteers
- 150 people
- Sponsor
- Aristides Plaitis
Mitral Regurgitation
A Clinical Study of GeminiOne TEER System for the Treatment of Severe, Symptomatic MR.
To confirm the effectiveness and safety of the GeminiOne Transcatheter Mitral Valve Repair System for the treatment of severe, symptomatic mitral regurgitation.
- Trial name
- NCT07086534
- Testing
- GeminiOne Transcatheter Edge-to-Edge Repair (TEER) System
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Sierra Valve LLC
Mitral Regurgitation, Degenerative Mitral Valve Disease
Safety and Efficacy of the GeminiOne Transcatheter Valve Edge-to-Edge Repair System in Patients With Moderate-severe or Severe Degenerative Mitral Regurgitation
To observe and evaluate the safety and efficacy of the GeminiOne Transcatheter Valve Edge-to-Edge Repair System in Patients With Moderate-severe or Severe Degenerative Mitral Regurgitation through a prospective, multicenter…
- Trial name
- NCT05655897
- Testing
- GeminiOne Transcatheter Valve Edge-to-Edge Repair System
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Peijia Medical Technology (Suzhou) Co., Ltd.
Mitral Regurgitation
STrategies for Antithrombotic tReatment Following Transcatheter Edge-to-Edge Repair in Patients Without an Indication for Oral Anticoagulant
Mitral regurgitation (MR) is the most common valvular heart disease, affecting approximately 24.2 million people worldwide (with a higher prevalence in older age groups).
- Trial name
- STAR-TEER Ⅱ (NCT07007143)
- Testing
- Experimental: Aspirin monotherapy, Active Comparator: Aspirin+Clopidogrel
- Where
- China
- Volunteers
- 1,032 people
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
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
Mitral Regurgitation
STrategies for Antithrombotic tReatment Following Transcatheter Edge-to-Edge Repair in Patients With an Indication for Oral Anticoagulant
Mitral regurgitation (MR) is the most common valvular heart disease, affecting approximately 24.2 million people worldwide (with a higher prevalence in older age groups).
- Trial name
- STAR-TEER Ⅰ (NCT06901466)
- Testing
- Experimental: Rivaroxaban monotherapy, Active Comparator: Rivaroxaban+Clopidogrel
- Where
- China
- Volunteers
- 880 people
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
Mitral Regurgitation, Heart Failure
Remote Monitoring of Patients With Functional Mitral Regurgitation Undergoing Mitraclip Transcatheter Repair
HERMES is a pilot study which aims at exploring the impact of remote monitoring in patients with severe functional mitral regurgitation undergoing transcatheter mitral valve edge-to-edge repair with the Mitraclip system.
- Trial name
- HERMES (NCT02698150)
- Testing
- HERMES tablet
- Where
- Italy
- Volunteers
- 55 people
- Sponsor
- Azienda Ospedaliero, Ferrarotto Alessi
Mitral R, Mitral Regurgitation
Structural Heart Surgery Assist System for Transcatheter Mitral Valve Edge-to-Edge Repair (TEER).
This trial aims to evaluate the safety and efficacy of the Structural Heart Surgery Assist System in assisting TEER for patients with moderate-to-severe or greater degenerative or functional mitral regurgitation (MR ≥3+).
- Trial name
- NCT07055919
- Testing
- Structural Heart Surgery Assist System, Manual MitraClip G4
- Where
- China
- Volunteers
- 112 people
- Sponsor
- Xiamen Cardiovascular Hospital, Xiamen University
Atrial Fibrillation (AF), Mitral Valve (MV) Regurgitation
EPX-HTG for Structural Heart Procedures
To investigate and evaluate the benefits of adding EchoPixel Holographic Therapy Guidance to the current standard of care in Structural Heart (SH) procedures.
- Trial name
- EPX-HTG-2026 (NCT07705425)
- Testing
- Left Atrial Appendage Occlusion, Mitral Valve Transcatheter Edge to Edge Repair
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- EchoPixel, Inc.