Clinical trials: Edge-to-Edge Mitral Valve Repair
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
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
Degenerative Mitral Valve Disease
Clinical Study of NovoClasp for Treating Moderate to Severe and Severe Degenerative Mitral Regurgitation
To validate the safety and efficacy of transcatheter edge-to-edge repair (TEER) using the NovoClasp® transcatheter mitral valve clip and steerable guide catheter in the treatment of moderate to severe and severe degenerative…
- Trial name
- NCT06021509
- Testing
- NovoClasp® transcatheter mitral valve clip and steerable guide catheter
- Where
- China
- Volunteers
- 102 people
- Sponsor
- Enlight Medical Technologies (Shanghai) Co., Ltd
Mitral Regurgitation
Change in LVEF Following Transcatheter Mitral Edge-To-Edge Repair
Little is known regarding the impact of transcatheter mitral valve edge-to-edge repair (TEER) on the acute changes in left ventricular ejection fraction (LVEF) and the effect of an acute reduction in LVEF, the so-called…
- Trial name
- MITRA-EF (NCT05311163)
- Testing
- MitraClip
- Where
- Israel
- Volunteers
- 4,000 people
- Sponsor
- Rabin Medical Center
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
Mitral Regurgitation
Edge-To-Edge Technique Used as a Bailout in Case of Sub-Optimal Mitral Repair: Very Long-Term Results
The absence of residual mitral regurgitation (MR) after mitral valve repair is of paramount importance for the long term durability of the valve repair.
- Trial name
- NCT05733988
- Testing
- Bailout edge to edge
- Where
- Italy
- Volunteers
- 81 people
- Sponsor
- Michele De Bonis
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 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
Mitral Regurgitation
Invasive Hemodynamic Response to Transcatheter Edge-to-Edge Mitral Valve Repair
Studying the effects of Trans-catheter Mitral Valve Repair (TMVr) on the hemodynamics and biomarkers in patients with severe mitral valve regurgitation.
- Trial name
- NCT04200378
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Mayo Clinic
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, 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
Atrial Functional Mitral Regurgitation, Mitral Insufficiency
Assessment of Transcatheter Edge-to-Edge Repair in Atrial Functional Mitral Regurgitation (ATRIAL-MR)
This investigator-initiated, multicenter, international, retrospective registry aims to investigate outcomes of patients with atrial functional mitral regurgitation, as treated in clinical routine.
- Trial name
- NCT06911099
- Where
- 22 sites in United States, Canada and 4 more
- Volunteers
- 1,000 people
- Sponsor
- University Hospital of Cologne
Mitral Regurgitation
Outcomes of Patients tReated wIth Mitral Transcatheter Edge-to-edge Repair for Primary Mitral Regurgitation Registry
This multinational, non-interventional, investigator-initiated, retrospective study aims to investigate outcomes of patients, who underwent mitral valve transcatheter edge-to-edge repair (M-TEER) for primary mitral regurgitation…
- Trial name
- PRIME-MR (NCT05332782)
- Where
- 6 sites in United States, France and 1 more
- Volunteers
- 2,000 people
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
Severe Mitral Regurgitation
Prediction of Reverse Remodeling and Outcome in Patients With Severe Secondary Mitral Valve Regurgitation Undergoing Transcatheter Edge-to-edge Mitral Valve Repair
The investigators' hypothesis is that CMR tissue characterization and myocardial function analysis acquired by CMR feature tracking technique predict reverse remodeling in patients with severe secondary mitral regurgitation (MR)…
- Trial name
- PRE-MITRA (NCT04913727)
- Testing
- Cardiac magnetic resonance imaging before the procedure, Transcatheter mitral edge-to-edge repair.
- Where
- Switzerland
- Volunteers
- 300 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Pulmonary Hypertension, Pulmonary Hypertension Associated With HFpEF
Percutaneous Pulmonary Artery Denervation (PADN) for the Treatment of Pulmonary Hypertension After Transcatheter Mitral Valve Edge-to-Edge Repair (M-TEER): A Prospective Cohort Study
this study aims to investigate the efficacy and safety of PADN therapy compared with standard medical therapy in patients diagnosed with pulmonary hypertension after M-TEER, thereby providing evidence for clinical treatment…
- Trial name
- NCT07662655
- Testing
- Percutaneous Pulmonary Artery Denervation (PADN), Control group (receiving standard medical therapy alone)
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Xiamen Cardiovascular Hospital, Xiamen University
Mitral Regurgitation
Comparison of Transcatheter Edge-to-edge Repair Using Echo Only with Echo Combined with X Ray for Mitral Regurgitation (ECHO-CLIP)
Mitral regurgitation (MR) is a common valvular heart disease in the elderly population, frequently associated with poor prognosis if not treated.
- Trial name
- NCT06684171
- Testing
- Echocardiographic guidance, Fluoroscopic guidance
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Pan Xiangbin
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
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
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
Heart Failure With Reduced Ejection Fraction, Mitral Regurgitation
The CardioClip Study
The CardioClip study is exploring the use of a wireless sensor to monitor pressure in the pulmonary artery. This sensor is inserted much like the mTEER procedure, a non-surgical method through a vein in the groin.
- Trial name
- CardioClip (NCT06241430)
- Testing
- CardioMEMS
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Columbia University