Clinical trials: Mitral Valve Replacement, open to volunteers
Mitral Annular Calcification, Mitral Stenosis
The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves).
A prospective multicenter study enrolling high surgical risk patients with severe mitral annular calcification (MAC) and symptomatic mitral valve dysfunction (severe stenosis, ≥ moderate to severe regurgitation, or mixed ≥…
- Conditions
- Mitral Annular Calcification, Mitral Stenosis, Mitral Regurgitation, Mitral Valve Disease
- Trial name
- MITRAL-II (NCT04408430)
- Testing
- Transseptal ViMAC
- Where
- 17 sites in United States, Mexico
- Volunteers
- 210 people
- Sponsor
- Mayra Guerrero
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 Replacement
Replacement of the Native Mitral Valve Using the ReValve System
This study is to collect preliminary chronic information on performance and safety of the ReValve System.
- Trial name
- NCT07601269
- Testing
- ReValve System
- Where
- 2 sites in Brazil
- Volunteers
- 25 people
- Sponsor
- ReValve Solutions Inc.
Aortic Valve Replacement in Patients With Moderate Aortic Stenosis Combined With Mitral Regurgitation
Early Versus Deferred Aortic Valve Replacement in Patients With Moderate Aortic Stenosis and Mitral Regurgitation
The aim of the present study is to investigate safety and efficacy of early versus deferred aortic valve replacement in patients with moderate aortic stenosis combined with moderate mitral regurgitation.
- Trial name
- TIAMAR (NCT05310461)
- Testing
- Transcatheter or surgical aortic valve replacement with or without transcatheter or surgical mitral valve repair/replacement, Deferred treatment, with intervention once AVA is ≤1.0 cm2 or if concomitant mitral regurgitation meets an indication for intervention
- Where
- 3 sites in Switzerland
- Volunteers
- 80 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Mitral Regurgitation
The REValve Clinical Trial an Evaluation Of the ReValve Palmetto Valve for the Replacement of the Native Mitral VaLVE
An evaluation of the ReValve System for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve surgery.
- Trial name
- The REsOLVE Tr (NCT07450911)
- Testing
- ReValve System
- Where
- 3 sites in Georgia
- Volunteers
- 20 people
- Sponsor
- ReValve Solutions Inc.
Mitral Regurgitation
Safety and Efficacy of the HighLife Transcatherter Mitral Valve Replacement System in Patients With Moderate-severe or Severe Mitral Regurgitation in China
To observe and evaluate the safety and efficacy of the HighLife Transcatheter Mitral Valve Replacement System in patients with moderate-severe or severe mitral valve regurgitation through a prospective, multicenter clinical trial…
- Trial name
- NCT05610566
- Testing
- the HighLife Trans-Septal Transcatheter Mitral Valve Replacement System
- Where
- China
- Volunteers
- 110 people
- Sponsor
- Peijia Medical Technology (Suzhou) Co., Ltd.
Mitral Valve Regurgitation
Mi-thos® Transcatheter Mitral Valve Replacement Study
To evaluate the safety and performance of the Mi-thos® Mitral Heart Valve with the Mi-thos® Transcatheter Delivery System.
- Trial name
- NCT04195984
- Testing
- Mi-thos® valve and transapical delivery system
- Where
- 3 sites in China
- Volunteers
- 122 people
- Sponsor
- Shanghai NewMed Medical Co., Ltd.
Aortic Valve Disease, Mitral Valve Disease, Prosthetic Heart Valve Dysfunction, Valvular Heart Disease Requiring Surgical Aortic or Mitral Valve Replacement
Safety and Performance of Dafodil Heart Valves in Real-World Aortic and Mitral Valve Replacement
This study, called the EuroDafodil Registry, is being conducted to understand how safe and effective the Dafodil™ and Dafodil Neo™ Pericardial Bioprosthetic heart valves are when used in routine medical practice.
- Trial name
- NCT07379112
- Testing
- Dafodil™ / Dafodil Neo™ Pericardial Bioprosthetic Heart Valve
- Volunteers
- 500 people
- Sponsor
- Meril Life Sciences Pvt. Ltd.
Mitral Regurgitation
HighFLO Study - HighLife Trans-septal Mitral Valve Replacement (TSMVR) Feasibility Study of the Open Cell CLARITY Valve
Feasibility, safety and performance of the HighLife CLARITY TSMV and its delivery system
- Trial name
- HighFLO (NCT04888247)
- Testing
- CLARITY
- Where
- 14 sites in Australia, Belgium and 4 more
- Volunteers
- 30 people
- Sponsor
- HighLife SAS
Mitral Regurgitation
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Evaluate the safety and efficacy of Medtronic Intrepid™ TMVR TF System in patients with moderate-to-severe or severe symptomatic mitral regurgitation, or moderate symptomatic mitral regurgitation combined with mitral stenosis in…
- Trial name
- APOLLO-EU (NCT05496998)
- Testing
- Medtronic Intrepid™ TMVR TF System
- Where
- 38 sites in Denmark, France and 6 more
- Volunteers
- 400 people
- Sponsor
- Medtronic Cardiovascular
Mitral Valve Regurgitation
First-In-Human Clinical Study for Treatment of Severe Mitral Valve INsufficiency With Epygon™ TRanscatheter Mitral VAlve System
The EPYGON VALVE is an innovative mitral valve, intended for valve replacement of a native mitral valve through a minimally invasive implant procedure by means of a dedicated implant device.
- Trial name
- NCT04775108
- Testing
- Epygon™ Transcatheter Mitral Valve System
- Where
- 10 sites in Austria, Italy and 2 more
- Volunteers
- 40 people
- Sponsor
- Epygon
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
This is an early study of a catheter-based minimally invasive procedure called SESAME to slice thick heart muscle as described below.
- Conditions
- Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction, Systolic Anterior Motion
- Trial name
- NCT07806149
- Testing
- SESAME Procedure
- Where
- 8 sites in United States
- Volunteers
- 200 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Mitral Valve Disease
Hamburg TranscathEteR Mitral Valve REplacement RegiStry
The Hamburg TranscathEteR Mitral Valve REplacement RegiStry (HERMES) is a prospective clinical cohort registry aiming to gather follow-up information on short- and long-term outcome of patients with mitral valve disease that…
- Trial name
- HERMES (NCT04914468)
- Where
- Germany
- Volunteers
- 300 people
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
Mitral Regurgitation
Sutra Hemi-valve First-in-Human Study
Study to evaluate the feasibility, safety and performance of the Sutra Hemi-valve Transcatheter Mitral Valve Replacement System in patients with moderate-severe and severe symptomatic mitral regurgitation who are at high risk for…
- Trial name
- NCT06552689
- Testing
- Sutra Hemi-valve Transcatheter Mitral Valve Replacement (TMVR) System
- Where
- New Zealand
- Volunteers
- 15 people
- Sponsor
- Sutra Medical, Inc.
Degenerative Mitral Regurgitation
CardioFlow Transcatheter Mitral Valve Replacement System Pre-market Clinical Investigation
This is a prospective, multi-center, single-arm study to assess the safety and effectiveness of Microport CardioFlow Transcatheter Mitral Valve Replacement system in the treatment of moderate to severe or severe degenerative…
- Trial name
- NCT07857343
- Testing
- Microport CardioFlow Mitral Valve Replacement System
- Where
- 3 sites in China
- Volunteers
- 152 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Mitral Valve Regurgitation
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.
- Trial name
- APOLLO (NCT03242642)
- Testing
- Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
- Where
- 85 sites in United States, Canada and 1 more
- Volunteers
- 1,056 people
- Sponsor
- Medtronic Cardiovascular
Heart Valve Disease, Mitral Valve (MV) Regurgitation
Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease
The objective of this study is to evaluate and predict the progression of moderate cardiac valve stenosis and regurgitation using clinical, biological, echocardiographic, computed tomography (CT), and magnetic resonance imaging…
- Conditions
- Heart Valve Disease, Mitral Valve (MV) Regurgitation, Mitral Valve Disease, Mitral Valve Stenosis
- Trial name
- VALVE-COMPASS (NCT07267117)
- Where
- 15 sites in China
- Volunteers
- 10,000 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Mitral Valve Replacement, Mitral Insufficiency
Outcomes of Complete Versus Partial Preservation of the Sub-valvular Apparatus in Cases of Mitral Valve Replacement
The purpose of this study is to evaluate the outcomes of complete (preservation of both anterior and posterior leaflets) versus partial (preservation of posterior leaflet only) preservation of subvalvular apparatus in cases of…
- Trial name
- NCT06811662
- Testing
- mitral valve replacement
- Where
- Egypt
- Volunteers
- 80 people
- Sponsor
- Assiut University
Mitral Valve Failure, Surgery
Effects of Triflow and Deep Breathing and Cough Exercises on Respiration in Patients Undergoing Mitral Valve Replacement
The purpose of breathing exercises or the use of assistive devices is to provide deep breathing after surgery and to obtain a normal breathing pattern.
- Trial name
- NCT06997224
- Testing
- triflow application
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Atlas University
Mitral Regurgitation (MR)
Early Feasibility Study of the Capstan Medical TMVR System
This early feasibility study is evaluating the safety and performance of the Capstan Compass Robotic System™ for transcatheter mitral valve replacement in patients with symptomatic, moderate-to-severe or severe mitral…
- Trial name
- NCT07917208
- Testing
- Capstan Compass Robotic System for Transcatheter Mitral Valve Replacement
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Capstan Medical