Clinical trials: Mitral Heart Valve Disease
Mitral Valve (MV) Regurgitation
ACCESS-Europe A Two-Phase Observational Study of the MitraClip® System in Europe
The MitraClip System enables the European physicians an alternative therapeutic option for patients with mitral regurgitation (MR).
- Trial name
- ACCESS-EU (NCT01288976)
- Testing
- MitraClip, Medical Management, Mitral Valve Surgery
- Where
- Germany
- Volunteers
- 721 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation, Valve Heart Disease
Dabigatran Versus Conventional Treatment for Prevention of Silent Cerebral Infarct in Atrial Fibrillation Associated With Valvular Disease
The prevalence of AF, which is tachyarrhythmia, is approximately 2% of the entire population and 5% of the population at the age of 60 or older.
- Trial name
- DECISIVE (NCT02982850)
- Testing
- Dabigatran, Acetylsalicylic acid, Warfarin
- Where
- South Korea
- Volunteers
- 120 people
- Sponsor
- Asan Medical Center
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 Valve Insufficiency, Mitral Valve Regurgitation
Pivotal Study of a Percutaneous Mitral Valve Repair System
EVEREST II Randomized Controlled Trial (RCT) is a prospective, multi-center, randomized study of the MitraClip® System in the treatment of mitral valve regurgitation, randomizing patients to MitraClip or mitral valve surgery.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation
- Trial name
- EVERESTIIRCT (NCT00209274)
- Testing
- Percutaneous mitral valve repair using MitraClip implant, Mitral valve repair or replacement surgery
- Where
- United States
- Volunteers
- 279 people
- Sponsor
- Abbott Medical Devices
Mitral Regurgitation
An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System
Study to evaluate the feasibility, safety and performance of the HighLife trans-septal Transcatheter Mitral Valve in patients with moderate-severe and severe mitral regurgitation who are at high risk for surgical treatment.
- Trial name
- NCT04029337
- Testing
- Transcatheter Mitral Valve Replacement
- Where
- 10 sites in United States
- Volunteers
- 30 people
- Sponsor
- HighLife SAS
Mitral Regurgitation, Mitral Insufficiency
MiCLASP Post Market Clinical Follow-Up (PMCF) Study
This is a postmarket clinical follow up study on the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in transcatheter mitral…
- Trial name
- MiCLASP (NCT04430075)
- Testing
- Edwards PASCAL Transcatheter Valve Repair System and Edwards PASCAL Precision Transcatheter Valve Repair System
- Where
- 37 sites in Austria, Germany and 7 more
- Volunteers
- 1,000 people
- Sponsor
- Edwards Lifesciences
Mitral Regurgitation
Use of Phenylephrine for Assessment of Mitral Regurgitation Severity
The study proposes to develop a phenylephrine protocol to be used during transesophageal echocardiography, whereby intravenous phenylephrine would be used to increase afterload with the intent to mimic the awake hemodynamic…
- Trial name
- NCT04500899
- Testing
- Mydfrin
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Montefiore Medical Center
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
Atrial Fibrillation, Radiofrequency Catheter Ablation
Use of Radiofrequency Ablation to Eliminate Continuous Atrial Fibrillation in Patients Undergoing Mitral Valve Surgery
The aim of this prospective randomized clinical trial was to evaluate the early and late outcome following left atrial radiofrequency ablation during MV surgery for the treatment of continuous atrial fibrillation and to assess…
- Trial name
- NCT00238706
- Testing
- Radiofrequency ablation
- Sponsor
- University Hospitals, Leicester
Severe Mitral Valve Regurgitation, Severe Mitral Valve Stenosis
The Feasibility Study of Polymer Artificial Heart Valve for the Treatment the Mitral Valve Disease.
The study aims to evaluate the feasibility and safety of polymer artificial heart valve designed and developed by Shanghai HeartEpoch Medical technology Co. Ltd. for the treatment of the mitral valve diseases.
- Trial name
- HeartEpoch (NCT07243184)
- Testing
- mitral valve replacement
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Shanghai HeartEpoch Medical Technology Co., Ltd
Atrial Fibrillation and Flutter, Mechanical Mitral Valve Prosthesis
Impact of Education Level on Clinical Outcomes in Self-INR Managed Patients
Oral anticoagulation (OAC) is indicated in a wide variety of clinical conditions including atrial fibrillation (AF), mechanical valve prosthesis (MVP), deep vein thrombosis and pulmonary embolism.
- Trial name
- NCT06187155
- Testing
- INR self-management
- Where
- Egypt
- Volunteers
- 586 people
- Sponsor
- Cairo University
MITRAL REGURGITATION
(MitraClip in Non-Responders to Cardiac Resynchronization Therapy)
Functional mitral regurgitation (FMR) is a common finding in patients with dilated cardiomyopathy and reduced left ventricular ejection fraction (LVEF).
- Trial name
- MITRA-CRT (NCT02592889)
- Testing
- MITRACLIP
- Where
- Spain
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Hospital Clinic of Barcelona
Heart Valve Diseases or Prosthesis, Aortic Valve Stenosis
Comparison of Early Postoperative Outcomes Between Minimally Invasive Valve Surgery Via Right Thoracotomy and Conventional Valve Surgery Via Sternotomy.
This randomized controlled trial aims to compare early postoperative outcomes between Minimally Invasive Valve Surgery (MIVS) via right thoracotomy and Conventional Valve Surgery via median sternotomy in patients undergoing…
- Conditions
- Heart Valve Diseases or Prosthesis, Aortic Valve Stenosis, Aortic Valve Insufficiency, Valvular Heart Disease Stenosis and Regurgitation (Diagnosis)
- Trial name
- NCT07251660
- Testing
- Minimally Invasive Valve Surgery, Conventional Valve Surgery
- Volunteers
- 32 people
- Sponsor
- Chaudhry Pervaiz Elahi Institute of Cardiology
Pathological Processes, Cardiomyopathies
Adenosine as an Adjunct to Blood Cardioplegia
Myocardial protection is a major issue in cardiac surgery, since inadequate protection increases the risk of postoperative cardiac dysfunction.
- Trial name
- NCT02681913
- Testing
- Adenosine
- Where
- Netherlands
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Amphia Hospital
Mitral Valve Insufficiency, Aortic Valve Insufficiency
Effect of Anesthetics on Troponin I and С-reactive Protein
Abstract Troponin is one of the cardiac biomarkers and its high level correlates to high risk of cardiac myocytes damage. C-reactive protein (CRP) in cardiosurgery participates in the Systemic Inflammation Response Syndrome, and…
- Conditions
- Mitral Valve Insufficiency, Aortic Valve Insufficiency, Cardiac Disease
- Trial name
- NCT05742789
- Testing
- Propofol, Isoflurane, Sevoflurane
- Where
- Kazakhstan
- Volunteers
- 255 people
- Sponsor
- Astana Medical University
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
Degenerative Mitral Valve Disease, Mitral Valve Regurgitation
Chordal Repair for Transcatheter Mitral Valve Repair (TMVr)
A multi-center evaluation of the Pipeline chordal repair system for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve repair.
- Trial name
- NCT04281940
- Testing
- Transcatheter implantation of chordal repair system
- Where
- 4 sites in Georgia, Paraguay and 1 more
- Volunteers
- 7 people
- Sponsor
- Pipeline Medical
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
Cryotherapy Effect, Post Operative Pain
Cryoanalgesia and Post-thoracotomy Pain in Minimally Invasive Cardiothoracic Surgery
Minimally invasive cardiothoracic surgery is often associated with chronic pain syndrome, out of keeping with the extent of surgical dissection.
- Trial name
- NCT05255146
- Testing
- Atricure Inc. Nitrous oxide Cryoprobe
- Sponsor
- University of Alberta