Clinical trials: Valve Regurgitation, Mitral
Mitral Valve Regurgitation (Degenerative or Functional)
TVMR With the Innovalve System Trial - Pilot in Georgia
Study to evaluate the safety and performance of the Innovalve mitral valve replacement system
- Trial name
- TWIST-PILOT-GE (NCT05682066)
- Testing
- Innovalve MR system
- Where
- Georgia
- Volunteers
- 11 people
- Sponsor
- Edwards Lifesciences
Mitral Regurgitation Functional
Noninferiority Trial of MitraClip Implantation Strategies: 1 Clip vs. 2 Clips in Patients With Functional Mitral Regurgitation
Implantation of the MitraClip has become the most frequently used percutaneous technique to treat significant (grade 3+ or 4+) mitral regurgitation (MR) in elderly patients deemed inoperable or at high surgical risk.
- Trial name
- One-Plus-One (NCT03503851)
- Testing
- MitraClip implantation
- Sponsor
- Asklepios proresearch
Mitral Regurgitation
The Effect of Percutaneous Superior Venae Cava Cannulation Clamping on Cerebral Near Infrared Spectroscopy in MICS
The use of minimally invasive cardiac surgery has progressed over the last 5-10 years to allow access to the heart through a small incision in the right chest.
- Trial name
- NIRSinMICS (NCT01166841)
- Testing
- PSVC line clamped
- Where
- Canada
- Volunteers
- 35 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
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 Valve Insufficiency, Left Ventricular Dysfunction
Pharmacological Reduction of Functional, Ischemic Mitral REgurgitation
Functional MR is caused by adverse left ventricular remodeling after myocardial injury and associated with an increased incidence of heart failure and death.
- Trial name
- PRIME (NCT02687932)
- Testing
- LCZ696, Valsartan
- Where
- 4 sites in South Korea
- Volunteers
- 118 people
- Sponsor
- Asan Medical Center
Mitral Regurgitation
Beating Heart Mitral Valve Repair With the HARPOON™ System
The objective of the study is to evaluate the safety and effectiveness of the HARPOON™ System in the treatment of patients with severe degenerative mitral regurgitation (DMR).
- Trial name
- RESTORE (NCT04375332)
- Testing
- HARPOON™ Beating Heart Mitral Valve Repair System
- Where
- 9 sites in United States
- Volunteers
- 25 people
- Sponsor
- Edwards Lifesciences
Mitral Regurgitation, Tricuspid Regurgitation
Early Discharge After Mitral and Tricuspid Edge-to-edge Repair: an Assessment of Feasibility and Safety
Mitral regurgitation (MR) and tricuspid regurgitation (TR) are common causes of breathlessness, fluid retention and other heart failure symptoms, which lead to reduced quality of life and frequent hospitalisation.
- Conditions
- Mitral Regurgitation, Tricuspid Regurgitation, Mitral Repair, Heart Failure
- Trial name
- EARLY-Edge (NCT06343363)
- Testing
- Early discharge protocol
- Where
- United Kingdom
- Volunteers
- 127 people
- Sponsor
- Oxford University Hospitals NHS Trust
Myocardial Ischemia, Coronary Arteriosclerosis
Safety and Efficacy of TP10, a Complement Inhibitor, in Adult Women Undergoing Cardiopulmonary Bypass Surgery
The purpose of this study is to determine if the study drug (TP10), which blocks complement release, can reduce such side effects of complement inflammation as chest pain or heart attacks and be taken safely in women who undergo…
- Conditions
- Myocardial Ischemia, Coronary Arteriosclerosis, Aortic Valve Insufficiency, Mitral Valve Insufficiency
- Trial name
- NCT00082121
- Testing
- TP10
- Where
- 18 sites in United States
- Volunteers
- 300 people
- Sponsor
- Avant Immunotherapeutics
Mitral Regurgitation
Tendyne European Experience Registry
TENDER is a multicenter, single-device, retrospective and prospective, observational study to assess safety and efficacy of the Tendyne Mitral Valve System in a real-world population.
- Trial name
- TENDER (NCT04898335)
- Testing
- Tendyne Mitral Valve System
- Where
- 30 sites in Austria, Belgium and 8 more
- Volunteers
- 400 people
- Sponsor
- LMU Klinikum
Mitral Valve Insufficiency, Aortic Stenosis Senile
Clinical and Geriatric Assessment in Elderly Patients Before and After TAVI or MitraClip Positioning
Since October of 2014, the Policlinico Umberto I Hospital has an "Heart Team", a group of selected specialists with the task of assessing and identifying eligible patients for valvular aortic transcatheter implantation (TAVI) or…
- Trial name
- NCT03145376
- Testing
- geriatric assessment
- Where
- 2 sites in Italy
- Volunteers
- 100 people
- Sponsor
- University of Roma La Sapienza
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
Aortic Stenosis, Mitral Regurgitation
Treatment of Concomitant Mitral Regurgitation by Mitral Valve Clipping in Patients With Successful Transcatheter Aortic Valve Implantation.
To evaluate whether patients after successful transfemoral transcatheter aortic valve implantation (TAVI), who have concomitant, moderate to severe mitral regurgitation (MR) benefit from an additional treatment of this valve…
- Trial name
- MITAVI (NCT04009434)
- Testing
- Mitral Valve Clipping, TAVI
- Where
- Germany
- Volunteers
- 1,162 people
- Sponsor
- Technische Universität Dresden
Rheumatic Heart Disease, Acute Rheumatic Fever
Rheumatic Heart Disease in Peru: Prevalence and Cardiovascular Outcomes Among Schoolchildren
Rheumatic heart disease remains a major challenge in low and middle income countries. Early detection of clinically silent valvular lesions by screening echocardiography allows timely implementation of secondary antibiotic…
- Trial name
- NCT02353663
- Testing
- Echocardiography
- Where
- 2 sites in Peru, Switzerland
- Volunteers
- 1,023 people, healthy volunteers welcome
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Mitral Regurgitation, Mitral Valve Disease
Caisson Transcatheter Mitral Valve Replacement (TMVR)
The purpose of this study is to assess the safety and performance of Transcatheter Mitral Valve Replacement (TMVR) system for the treatment of severe, symptomatic mitral regurgitation (MR).
- Conditions
- Mitral Regurgitation, Mitral Valve Disease, Mitral Valve Failure, Mitral Disease
- Trial name
- INTERLUDE (NCT03661398)
- Testing
- Transcatheter Mitral Valve Replacement
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Caisson Interventional LLC
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
Molecular Mechanisms of Volume Overload-Aim 1(SCCOR in Cardiac Dysfunction and Disease)
The investigators hypothesize that beta-1 receptor blockade (ß1-RB) attenuates extracellular matrix (ECM) degradation and progressive adverse Left Ventricular (LV) remodeling and failure in the volume overload of mitral…
- Trial name
- P1A1 (NCT01052428)
- Testing
- metoprolol succinate (Toprol XL)
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Mitral Valve Regurgitation (Degenerative or Functional)
TVMR With the Innovalve System Trial - TWIST-BE TWIST-PILOT-BE
Study to evaluate the safety and performance of the Innovalve mitral valve replacement system
- Trial name
- NCT05263375
- Testing
- Innovalve TMVR system
- Sponsor
- Innovalve Bio Medical Ltd.
Mitral Regurgitation
MitraClip System in Australia and New Zealand
The primary objective of the MitraClip System Australia and New Zealand (ANZ) Clinical Trial is to gather real-world clinical and health-economic outcome data to support the long-term safety, efficacy and economic value of the…
- Trial name
- MitraClipANZ (NCT01301625)
- Testing
- MitraClip Implant
- Where
- 6 sites in Australia
- Volunteers
- 78 people
- Sponsor
- Abbott Medical Devices
Mitral Insufficiency, Mitral Stenosis
Polish Transcatheter Transfemoral Mitral Valve-in-Valve Implantation (Mitral ViV) Registry
In recent years increasing number of mitral bioprosthesis implantation, especially in elderly population, is observed. Bioprosthetic valves are associated with a lower risk of thrombotic and bleeding adverse events compared with…
- Conditions
- Mitral Insufficiency, Mitral Stenosis, Mitral Stenosis With Insufficiency, Heart Failure
- Trial name
- NCT05625607
- Testing
- Transcatheter mitral valve-in-valve implantation
- Where
- 7 sites in Poland
- Volunteers
- 100 people
- Sponsor
- Medical University of Warsaw
Mitral Regurgitation, Mitral Valve Insufficiency
The ENCIRCLE Trial
This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are…
- Trial name
- ENCIRCLE (NCT04153292)
- Testing
- SAPIEN M3 valve and dock
- Where
- 54 sites in United States, Australia and 4 more
- Volunteers
- 786 people
- Sponsor
- Edwards Lifesciences