Clinical trials: Mitral Valve Regurgitation
Mitral Prosthetic Valve Stenosis and Regurgitation
Redo Surgery or Transcatheter Valve-in-Valve for Mitral Bioprosthetic Dysfunction (SURViV)
Transcatheter valve-in-valve implantation has emerged as a valid alternative to redo surgery for patients with surgical bioprosthetic dysfunction.
- Trial name
- SURVIV (NCT04402931)
- Testing
- Transcatheter Valve-in-Valve Intervention, Redo Mitral valve surgery
- Where
- 7 sites in Brazil
- Volunteers
- 150 people
- Sponsor
- Instituto Dante Pazzanese de Cardiologia
Mitral Valve Regurgitation
STS/ACC TVT Registry Mitral Module
The TVT Registry™ is a benchmarking tool developed to track patient safety and real-world outcomes related to the transcatheter mitral valve repair (TMVR) procedure.
- Trial name
- TMVR (NCT02245763)
- Testing
- Leaflet Clip
- Where
- United States
- Volunteers
- 4,000 people, healthy volunteers welcome
- Sponsor
- American College of Cardiology
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
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
Mitral Regurgitation (MR)
Mitral Valve Repair With the Chord-X System: A Long Term Evaluation
The goal of this clinical trial is to strengthen the evidence available for the Chord-X System by collecting follow-up data from patients who underwent Chord-X implant and to evaluate the long-term safety and performance data…
- Trial name
- METRIX (NCT07413926)
- Testing
- Chord-X system implant
- Where
- 4 sites in United States, Italy and 1 more
- Volunteers
- 110 people
- Sponsor
- Artivion Inc.
Mitral Regurgitation, Pain, Postoperative
Cryoablation of Intercostal Nerves for Pain Management in Early Postoperative Period in Patients With Minimally Invasive Mitral Valve Surgery
A single-center, pilot, prospective, randomized clinical trial with a 1:1 allocation ratio. The aim of our trial is to determine whether cryoablation of intercostal nerves provides a clinically significant analgesic effect, which…
- Trial name
- BLOCK (NCT06443931)
- Testing
- cryoablation of intercostal nerves
- Where
- Russia
- Volunteers
- 30 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Mitral Regurgitation, Mitral Valve Disease
ALLIANCE Mitral: Safety and Effectiveness of SAPIEN X4 Transcatheter Heart Valve - Mitral
This study will establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects who are at high or greater surgical risk with a failing mitral surgical bioprosthetic valve or a failing…
- Conditions
- Mitral Regurgitation, Mitral Valve Disease, Mitral Stenosis
- Trial name
- NCT06167213
- Testing
- SAPIEN X4 THV
- Volunteers
- 125 people
- Sponsor
- Edwards Lifesciences
Mitral Regurgitation (MR), Pediatric Cardiac Surgery
A Prospective Multicenter Cohort Study on Surgical Treatment Strategies for Pediatric Mitral Regurgitation
This prospective, multicenter cohort study aims to evaluate the outcomes of surgical repair for pediatric mitral regurgitation (MR) in China.
- Trial name
- NCT07284212
- Testing
- conventional mitral valve repair, standardized mitral valve repair
- Where
- China
- Volunteers
- 427 people
- Sponsor
- China National Center for Cardiovascular Diseases
Mitral Valve Insufficiency, Mitral Valve Disease
PARTNER 3 Trial - Mitral Valve in Valve
To assess the safety and effectiveness of the SAPIEN 3 transcatheter heart valve in patients with a failing mitral bioprosthetic valve.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Disease, Mitral Valve Regurgitation, Heart Failure
- Trial name
- NCT03193801
- Testing
- Edwards SAPIEN 3 transcatheter valve, Model 9600TFX
- Where
- 12 sites in United States, Australia and 1 more
- Volunteers
- 53 people
- Sponsor
- Edwards Lifesciences
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 Valve Regurgitation, Mitral Regurgitation
MitraClip EXPAND G4 Study
This primary objective of the EXPAND G4 study is to confirm the safety and performance of the MitraClip G4 System in a post-market setting.
- Trial name
- NCT04177394
- Testing
- MitraClip G4 System
- Where
- 63 sites in United States, Canada and 8 more
- Volunteers
- 1,164 people
- Sponsor
- Abbott Medical Devices
Acute Heart Failure With Reduced Ejection Fraction, Decompensation; Heart, Congestive
The FOCUS-ADHF Registry
Acute heart failure (AHF) represents a significant clinical and economic burden due to its impact on patients' quality of life, poor prognosis, and high healthcare costs.
- Conditions
- Acute Heart Failure With Reduced Ejection Fraction, Decompensation; Heart, Congestive, Regurgitation, Mitral
- Trial name
- FOCUS-ADHF (NCT06726109)
- Where
- 4 sites in Belgium, Italy
- Volunteers
- 600 people
- Sponsor
- ASL Città di Torino
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
Aortic Stenosis, Mitral Regurgitation
Evaluating Infrasonic Hemodynography
This comparative diagnostic accuracy study will determine the accuracy of a noninvasive wearable infrasonic sensor to detect the mechanical, electrical, and hemodynamic function of the cardiovascular system.
- Conditions
- Aortic Stenosis, Mitral Regurgitation, Pulmonary Hypertension, Heart Failure, Systolic
- Trial name
- NCT04636892
- Testing
- MindMics earbud
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Scripps Health
Mitral Regurgitation, Coronary Artery Disease
Randomised Ischaemic Mitral Evaluation (RIME) Trial
The study is a randomised controlled trial comparing two treatment strategies for patients with moderate functional ischaemic mitral regurgitation undergoing coronary artery bypass grafting (CABG).
- Trial name
- RIME (NCT00413998)
- Testing
- CABG + Mitral valve annuloplasty, CABG
- Where
- 9 sites in Poland, United Kingdom
- Volunteers
- 73 people
- Sponsor
- Imperial College London
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
Cardiac Valve Disease, Paravalvular Aortic Regurgitation
European Multicentre Registry of Percutaneous Paravalvular Leak Closure
Paraprosthetic cardiac valve leaks are a progressive complication after after surgical or percutaneous heart valve replacement. These leaks can lead to heart failure and/or life-threatening hemolysis.
- Conditions
- Cardiac Valve Disease, Paravalvular Aortic Regurgitation, Paravalvular Mitral Regurgitation, Paravalvular Leak
- Trial name
- EuroPVL (NCT05506293)
- Testing
- percutaneous paravalvular leak closure
- Where
- 33 sites in Belgium, Czechia and 10 more
- Volunteers
- 400 people
- Sponsor
- Centre Chirurgical Marie Lannelongue
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
Mitral Regurgitation
A Pan-Canadian, Retrospective Evaluation of MitraClip Safety and Efficacy
The PREMISE Registry is a retrospective, observational study that will evaluate the efficacy and safety of the MitraClip in real-world Canadian practice.
- Trial name
- PREMISE (NCT03592043)
- Testing
- MitraClip
- Where
- Canada
- Volunteers
- 1,191 people
- Sponsor
- Population Health Research Institute
Functional Mitral Regurgitation, Heart Failure
Evaluation of Outcomes of CRT and MitraClip for Treatment of Low Ejection Fraction and Functional Mitral Regurgitation in HF
At present, the optimal treatment strategy for heart failure patients and moderate-to-severe (3+) or severe (4+) mitral regurgitation with a class IIa recommendation for CRT is uncertain.Whether these patents should also be…
- Trial name
- EVOLVE-HF (NCT02985268)
- Testing
- MitraClip, Optimal Medical Therapy, CRT-D
- Sponsor
- Montreal Heart Institute