Clinical trials: Mitral Heart Valve Disease
Mitral Regurgitation
Cardiovalve Transfemoral System - FIM Study
The Cardiovalve system is a replacement valve delivered through a transfemoral access and transseptal approach and is intended for symptomatic patients with Mitral regurgitation for whom surgical options are not feasible.
- Trial name
- NCT03958773
- Testing
- Cardiovalve transfemoral Mitral valve system
- Where
- Lithuania
- Volunteers
- 10 people
- Sponsor
- Cardiovalve Ltd.
Mitral Regurgitation
Cardiovalve Transfemoral Mitral Valve System
This study is to evaluate the safety and technical performance of the Cardiovalve Transfemoral Mitral Valve System with its associated procedure, to minimize mitral regurgitation.
- Trial name
- AHEAD (NCT03813524)
- Testing
- Cardiovalve Transfemoral Mitral Valve
- Where
- 2 sites in United States
- Volunteers
- 1 people
- Sponsor
- Cardiovalve Ltd.
Mitral Regurgitation, Heart Failure
Safety and Efficacy Study of the PTMA Device to Reduce Mitral Valve Regurgitation in Patients With Heart Failure
Improvement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implantable device residing in the coronary sinus
- Trial name
- PTOLEMY2Canada (NCT00815386)
- Testing
- Percutaneous transvenous mitral annuloplasty
- Where
- 3 sites in Canada
- Volunteers
- 20 people
- Sponsor
- Viacor
Mitral Valve Regurgitation
New Techniques to Evaluate Mitral Regurgitation
Background: Mitral regurgitation, or leaking of the mitral heart valve, is usually studied and assessed with an ultrasound test called a two-dimensional (2D) echocardiogram.
- Trial name
- NCT01063322
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Mitral Regurgitation, Mitral Valve Insufficiency
Erector Spinae Plane Block for Minimally Invasive Mitral Valve Surgery
The goal of this project is to study whether local anesthetic via the erector spinae plane (ESP) block may be beneficial in minimally invasive mitral valve surgery (MIMVS).
- Conditions
- Mitral Regurgitation, Mitral Valve Insufficiency, Mitral Valve Prolapse
- Trial name
- NCT04770961
- Testing
- Erector spinae plane catheter with 0.5% Ropivacaine, Erector spinae plane catheter with saline
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of California, San Francisco
Mitral Regurgitation, Local Anaesthesia
Deep Sedation Instead of General Anaesthesia in Percutaneous Mitral Valve Repair Using the MitraClip® System
Percutaneous mitral valve repair (PMVR) with the MitraClip® system has emerged as a therapeutic alternative to surgical valve repair in patients who are at high risk and unsuitable for surgery.
- Conditions
- Mitral Regurgitation, Local Anaesthesia, Percutaneous Repair
- Trial name
- NCT02023762
- Volunteers
- 21 people
- Sponsor
- Heinrich-Heine University, Duesseldorf
Atrial Functional, Mitral Regurgitation (MR)
PRECISE-AFMR I: Transcatheter Mitral Valve Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation in Patients at High Surgical Risk
Atrial functional mitral regurgitation (AFMR) develops when enlargement and remodeling of the left atrium and mitral annulus prevent the mitral valve leaflets from closing completely, allowing blood to leak backward through the…
- Trial name
- PRECISE-AFMR I (NCT07741253)
- Testing
- Transcatheter Edge-to-Edge Repair
- Where
- China
- Volunteers
- 182 people
- Sponsor
- China National Center for Cardiovascular Diseases
Congestive Heart Failure, Ischemic Cardiomyopathy
Cardiac Output Pulmonary Arterial Catheter Compared to FloWave™ 1000
The purpose of this study is to compare cardiac output results obtained using the thermodilution push technique with the Pulmonary Arterial Catheter (PAC) to the predicted cardiac output results obtained from the non-invasive…
- Conditions
- Congestive Heart Failure, Ischemic Cardiomyopathy, Mitral Valve Prolapse, Mitral Regurgitation
- Trial name
- NCT00665301
- Where
- 3 sites in United States
- Volunteers
- 54 people
- Sponsor
- Woolsthorpe Technologies, LLC
Mitral Regurgitation
Double Transseptal Guide Sheath to Prevent Dock Drop During SAPIEN M3 Transcatheter Mitral Valve Replacement
This study looks at a heart procedure called transcatheter mitral valve replacement. Doctors use a device called SAPIEN M3 to replace a damaged heart valve.
- Trial name
- DGS-M3 (NCT07878195)
- Where
- Austria
- Volunteers
- 77 people
- Sponsor
- Medical University of Vienna
Mitral Valve Insufficiency
Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair
The objective of this trial is to assess the safety and effectiveness of the study device in subjects with degenerative mitral valve disease receiving a mitral valve repair without cardiopulmonary bypass (treatment group) when…
- Trial name
- ReChord (NCT02803957)
- Testing
- NeoChord DS1000, Surgical Mitral Valve Repair
- Where
- 14 sites in United States
- Volunteers
- 585 people
- Sponsor
- NeoChord
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 (Degenerative or Functional)
Edwards EVOQUE Eos MISCEND Study
Study to evaluate the safety and performance of the Edwards EVOQUE Eos mitral valve replacement system
- Trial name
- NCT02718001
- Testing
- Edwards EVOQUE Eos Mitral Valve Replacement System
- Where
- 19 sites in United States, Canada
- Volunteers
- 123 people
- Sponsor
- Edwards Lifesciences
Myocardial Infarction, Mitral Regurgitation
Medical Versus Surgical Management of Moderate Mitral Regurgitation Following Percutaneous Coronary Intervention
The pilot prospective randomized trial is designed to determine the safety and feasibility of enrolling patients to surgically correct residual Mitral Regurgitation (MR) following Percutaneous Coronary Intervention (PCI) for…
- Trial name
- NCT01156441
- Testing
- surgical mitral valve repair w/ mitral valve annuloplasty
- Where
- United States
- Sponsor
- Southern Illinois University
Cardiovascular Disease, Mitral Valve Repair
Carbon Dioxide Insufflation on Cerebral Microemboli
The purpose of this study is to determine if blowing carbon dioxide into the surgical field during open-heart surgery to displace retained chest cavity air from the atmosphere will decrease the number of microembolic being…
- Conditions
- Cardiovascular Disease, Mitral Valve Repair, Cerebral Microemboli, Cognitive Decline
- Trial name
- NCT00715845
- Testing
- Carbon dioxide insufflation
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- University Health Network, Toronto
Mitral Regurgitation
MitraClip® After Surgical Mitral Valve Repair
Percutaneous edge-to-edge repair of the mitral valve has been shown to be a safe and effective alternative treatment option for selected patients at high risk for cardiac surgery.
- Trial name
- MVRepair (NCT02853955)
- Testing
- Percutaneous edge-to-edge repair of the mitral valve
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- LMU Klinikum
Mitral Regurgitation, Heart Failure
Remote Monitoring of Patients With Functional Mitral Regurgitation Undergoing Mitraclip Transcatheter Repair
HERMES is a pilot study which aims at exploring the impact of remote monitoring in patients with severe functional mitral regurgitation undergoing transcatheter mitral valve edge-to-edge repair with the Mitraclip system.
- Trial name
- HERMES (NCT02698150)
- Testing
- HERMES tablet
- Where
- Italy
- Volunteers
- 55 people
- Sponsor
- Azienda Ospedaliero, Ferrarotto Alessi
Mitral Regurgitation, Heart Failure
Strain Imaging in Patients With Functional Mitral Regurgitation, Treated With MitraClip
The aim of this study is i) to evaluate left ventricular global longitudinal strain and myocardial work in patients with heart failure and severe functional mitral regurgitation one year after MitraClip implantation and compare…
- Trial name
- NCT04218578
- Testing
- speckle tracking analysis of transthoracic echocardiogram
- Where
- Greece
- Volunteers
- 100 people
- Sponsor
- University of Athens
Mitral Valve Regurgitation
Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY)
This is a prospective, multicenter, open-label, randomized trial comparing mitral valve (MV) transcatheter edge-to-edge repair (TEER) to surgical repair (1:1 ratio) in patients with primary, degenerative mitral regurgitation…
- Trial name
- PRIMARY (NCT05051033)
- Testing
- Mitral valve repair, Transcatheter edge-to-edge repair
- Where
- 66 sites in United States, Canada and 3 more
- Volunteers
- 450 people
- Sponsor
- Annetine Gelijns
HLH - Hypoplastic Left Heart Syndrome, DORV
Two-Year Study of the Safety and Efficacy of the Second-Generation Tissue Engineered Vascular Grafts
A single arm clinical trial evaluating the safety and efficacy of the second generation TEVG as vascular conduits for extracardiac total cavopulmonary connection.
- Conditions
- HLH - Hypoplastic Left Heart Syndrome, DORV, DILV - Double Inlet Left Ventricle, Mitral Atresia
- Trial name
- TEVG-2 (NCT04467671)
- Testing
- Tissue Engineered Vascular Grafts
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Nationwide Children's Hospital
Severe Mitral Regurgitation, Preserved Ventricular Ejection Fraction
Use of Pre-operative Global Longitudinal Strain to Predict Post-operative Left Ventricular Dysfunction in Mitral Regurgitation Surgery
Primary mitral regurgitation (MR) is the second most frequent valve disease requiring surgery and it is important to identify patients whose outcome could be improved with surgery by considering the risks and benefits.
- Trial name
- DysPO IM (NCT03968601)
- Testing
- Mitral regurgitation surgery such as mitral valve replacement or repair
- Where
- France
- Volunteers
- 79 people
- Sponsor
- University Hospital, Clermont-Ferrand