Clinical trials: Mitral Valve Failure
Aortic Stenosis, Mitral Stenosis
ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Bioprostheses With a New Tissue Treatment Platform (COMMENCE)
The objective of this trial is to confirm that the modifications to tissue processing, valve sterilization and packaging do not raise any new questions of safety and effectiveness in subjects who require replacement of their…
- Conditions
- Aortic Stenosis, Mitral Stenosis, Aortic Valve Insufficiency, Mitral Valve Insufficiency
- Trial name
- COMMENCE (NCT01757665)
- Testing
- Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M
- Where
- 32 sites in United States, Canada and 1 more
- Volunteers
- 777 people
- Sponsor
- Edwards Lifesciences
Heart Failure, Mitral Regurgitation
Montreal Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device
Reduction in mitral regurgitation due to safe placement of a PTMA device in the coronary sinus.
- Trial name
- PTOLEMY (NCT00571610)
- Testing
- PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant
- Where
- Canada
- Volunteers
- 5 people
- Sponsor
- Viacor
Rheumatic Heart Disease, Heart Failure
Dapagliflozin Effect on Rheumatic Mitral Stenosis
Rheumatic mitral stenosis remains a health problem in developing countries. Progressive fibrosis of the valves and myocardium is the main pathophysiology that plays an important role.
- Conditions
- Rheumatic Heart Disease, Heart Failure, Mitral Stenosis
- Trial name
- Dapa-Rhemis (NCT05618223)
- Testing
- Dapagliflozin
- Where
- Indonesia
- Volunteers
- 36 people
- Sponsor
- Universitas Sebelas Maret
Mitral Regurgitation, Mitral Valve Regurgitation
Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) and COAPT CAS
The purpose of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) Trial is to confirm the safety and effectiveness of the MitraClip…
- Conditions
- Mitral Regurgitation, Mitral Valve Regurgitation, Treatment of Functional Mitral Regurgitation in Symptomatic Heart Failure Subjects, Heart Failure
- Trial name
- COAPT (NCT01626079)
- Testing
- MitraClip System
- Where
- 86 sites in United States, Canada
- Volunteers
- 776 people
- Sponsor
- Abbott Medical Devices
Functional Mitral Regurgitation, Mitral Regurgitation
Edwards Cardioband System ACTIVE Pivotal Clinical Trial (ACTIVE)
To establish the safety and effectiveness of the Edwards Cardioband System in patients with functional mitral regurgitation (FMR).
- Conditions
- Functional Mitral Regurgitation, Mitral Regurgitation, Mitral Insufficiency
- Trial name
- ACTIVE (NCT03016975)
- Testing
- Edwards Cardioband System, Guideline Directed Medical Therapy
- Where
- 24 sites in United States
- Volunteers
- 12 people
- Sponsor
- Edwards Lifesciences
Mitral Valve Regurgitation
Treatment of Heart Failure and Associated Functional Mitral Valve Regurgitation
The objective of the study is to evaluate the safety and performance of the ARTO System in patients with mitral valve regurgitation (MR) associated with congestive heart failure (CHF).
- Trial name
- MAVERIC (NCT02302872)
- Testing
- ARTO System
- Where
- 9 sites in Australia, France and 3 more
- Volunteers
- 51 people
- Sponsor
- Mvrx, Inc.
Heart Failure, Mitral Valve Insufficiency
The CorCinch - Functional Mitral Valve Regurgitation (FMR) Study
This is a multi-center, non-randomized, prospective Early Feasibility Study to evaluate the AccuCinch® Ventricular Restoration System in patients with symptomatic heart failure and concomitant functional mitral regurgitation that…
- Conditions
- Heart Failure, Mitral Valve Insufficiency, Cardiomyopathies
- Trial name
- NCT02806570
- Testing
- Mitral valve repair
- Where
- 16 sites in United States
- Volunteers
- 35 people
- Sponsor
- Ancora Heart, Inc.
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
Right Heart Failure, Right Ventricular Dysfunction
PRediction of Early PostoperAtive Right vEntricular Failure in Mitral Valve Replacement/Repair Patients
The PREPARE-MVR (PRediction of Early PostoperAtive Right vEntricular failure in Mitral Valve Replacement/Repair patients) Study aims to evaluate those preoperative factors which can predict the early postoperative right…
- Conditions
- Right Heart Failure, Right Ventricular Dysfunction, Right Ventricular Failure, Mitral Valve Disease
- Trial name
- PREPARE-MVR (NCT03438825)
- Testing
- Mitral valve replacement/repair
- Where
- Hungary
- Volunteers
- 72 people
- Sponsor
- Semmelweis University Heart and Vascular Center
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 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 Valve Disease, Mitral Valve Stenosis
Early Feasibility Study for the Foldax TRIA Mitral Heart Valve Replacement
The purpose of this study is to conduct the initial clinical investigation of the Foldax Polymer Mitral Valve to collect evidence on the device's safety and performance.
- Conditions
- Mitral Valve Disease, Mitral Valve Stenosis, Mitral Valve Failure
- Trial name
- FOLDAX (NCT04717570)
- Testing
- Foldax TRIA Mitral Valve
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Foldax, Inc
Heart Failure - NYHA II - IV, Mitral Regurgitation Functional
Mitral Valve Edge-to-Edge Repair in Patients With Exercise-Induced Severe Mitral Regurgitation
The goal of this clinical trial is to learn whether mitral valve transcatheter edge-to-edge repair (TEER) in addition to guideline-directed medical therapy (GDMT) can improve clinical outcomes and symptoms in heart failure…
- Trial name
- MARCER (NCT07709208)
- Testing
- Guideline-Directed Medical Therapy (GDMT), Mitral valve TEER
- Where
- 2 sites in Germany
- Volunteers
- 246 people
- Sponsor
- Jena University Hospital
Mitral Valve Regurgitation
Caisson Transcatheter Mitral Valve Replacement (TMVR) System Early Feasibility Study
The purpose of this study is to assess the safety and performance of the Caisson Interventional Transcatheter MitralValve Replacement (TMVR) system for the treatment of severe symptomatic MitralValve Regurgitation (MR).
- Trial name
- PRELUDE (NCT02768402)
- Testing
- Caisson TMVR System
- Where
- 13 sites in United States
- Volunteers
- 20 people
- Sponsor
- Caisson Interventional LLC
Mitral Valve Insufficiency, Atrial Fibrillation
Left Atrial Distensibility to Predict Left Ventricular Filling Pressure and Prognosis in Patients With Severe Mitral Regurgitation
A large left atrial (LA) volume, which represents chronic diastolic dysfunction, is associated with a poor outcome, regardless of systolic function.
- Conditions
- Mitral Valve Insufficiency, Atrial Fibrillation, Heart Failure
- Trial name
- NCT01172184
- Testing
- Cardiac catheterization
- Where
- Taiwan
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- Kaohsiung Veterans General Hospital.
Systolic Heart Failure Stage D (Disorder), Mitral Regurgitation
The Prognostic Impact of Using High-dose Hydralazine in Severe Systolic Heart Failure With Hemodynamically Significant Mitral Regurgitation
Background: Severe systolic heart failure would be complicated with low cardiac output and high left ventricular filling pressure and the clinical presentations would be low blood pressure, poor peripheral perfusion, and…
- Trial name
- NCT04217135
- Testing
- evidence-based medications vs. high-dose hydralazine + evidence-based medications
- Where
- Taiwan
- Volunteers
- 400 people
- Sponsor
- Kaohsiung Veterans General Hospital.
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
Mitral Regurgitation Functional, Heart Failure
Optimizing Clinical Outcomes in Patients Undergoing Mitral Transcatheter Edge-to-edge Repair (M-TEER) for Severe Functional Mitral Regurgitation Towards Improved Guideline-directed Medical Therapy
A multi-centre, prospective, observational pilot registry in patients undergoing mitral valve repair for severe functional mitral regurgitation to report the heart failure drug therapy and dosing before the mitral valve procedure…
- Conditions
- Mitral Regurgitation Functional, Heart Failure, M-TEER
- Trial name
- MOTOR (NCT06702527)
- Testing
- Mitral transcatheter edge-to-edge repair
- Where
- 2 sites in Germany
- Volunteers
- 9 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Heart Failure, Mitral Regurgitation
Mitral Regurgitation Treatment in Advanced Heart Failure
MITRADVANCE-HF is a prospective, randomized, parallel-controlled, open-label, multicentre study trial enrolling patients with SMR and advanced HF on maximally tolerated standard of care therapies for HF according to the most…
- Trial name
- MITRADVANCE (NCT05292716)
- Testing
- MitraClip
- Where
- Italy
- Volunteers
- 172 people
- Sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Mitral Valve Failure
NHLBI DIR LAMPOON Study: Intentional Laceration of the Anterior Mitral Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Implantation
Background: Transcatheter mitral valve replacement (TMVR) is recommended for some people with mitral valve heart problems. But the usual TMVR techniques might cause an obstruction for some people.
- Trial name
- NCT03015194
- Testing
- Edwards SAPIEN 3 transcatheter heart valve, ASHI INTECC Astato XS 20
- Where
- 6 sites in United States
- Volunteers
- 32 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)