Clinical trials: Valve Regurgitation, Mitral
Mitral Regurgitation
Beating Heart Mitral Valve Repair With the HARPOON™ System
The objective of the study is to evaluate the safety and effectiveness of the HARPOON™ System in the treatment of patients with severe degenerative mitral regurgitation (DMR).
- Trial name
- RESTORE (NCT04375332)
- Testing
- HARPOON™ Beating Heart Mitral Valve Repair System
- Where
- 9 sites in United States
- Volunteers
- 25 people
- Sponsor
- Edwards Lifesciences
Takotsubo Syndrome
Italian Multicenter Observational Registry on Takostubo Syndrome
Takotsubo syndrome (TTS) has recently been described as an acquired form of cardiomyopathy whose pathophysiology is not yet well understood and mainly affects postmenopausal women.
- Trial name
- TIN (NCT06643949)
- Testing
- Echocardiography
- Volunteers
- 1,500 people
- Sponsor
- University of Molise
Mitral Valve Regurgitation, Heart Failure
Structural Heart and Valve Network PROSPECTIVE Registry
Background: Treatments for structural heart and valve disease are quickly changing. But treatment could be improved. Researchers want to gather data from people with this disease.
- Conditions
- Mitral Valve Regurgitation, Heart Failure, Heart Valve Disease, Tricuspid Valve Regurgitation
- Trial name
- NCT03928639
- Where
- United States
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Coronary Artery Disease, Mitral Valve Insufficiency
The Effects of Sevoflurane, Isoflurane and Propofol During Cardiac Surgery
Abstract Anaesthetic support for cardiac surgery significantly influences the course of the intraoperative period and the success of the postoperative period.
- Conditions
- Coronary Artery Disease, Mitral Valve Insufficiency, Aortic Valve Insufficiency
- Trial name
- NCT05695287
- Testing
- Propofol, Isoflurane, Sevoflurane
- Where
- Kazakhstan
- Volunteers
- 89 people
- Sponsor
- Astana Medical University
Mitral Valve Insufficiency
The Effect of Posterior Annulus Elevation Technique in Reducing Residual Regurgitation During Mitral Valve Repair in Children
The main problem in mitral valve repair surgery in children is the high number of postoperative residual lesions (49% of the total cases).
- Trial name
- NCT04518709
- Testing
- Posterior Mitral Annulus Elevation Technique, Conventional Mitral Valve Repair
- Volunteers
- 58 people
- Sponsor
- National Cardiovascular Center Harapan Kita Hospital Indonesia
Mitral Regurgitation (MR)
Use of Force Feedback Instruments With the da Vinci Surgical System, Model IS5000 for Mitral Valve Repair
This study aims to test the safety and effectiveness of Force Feedback instruments used during robotic-assisted mitral valve repair with the da Vinci Surgical System, Model IS5000 (dV5).
- Trial name
- NCT07655505
- Testing
- Mitral Valve Repair including the use of Force Feedback instruments
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Intuitive Surgical
Mitral Insufficiency, Heart Valve Disease
A Clinical Study of the CardiAQ™ TMVI System (Transapical DS)
The purpose of the study is to evaluate the initial short and long-term safety and performance of the CardiAQ™ Transcatheter Mitral Valve Implantation System using the Transapical Delivery System.
- Conditions
- Mitral Insufficiency, Heart Valve Disease, Cardiovascular Disease, Heart Disease
- Trial name
- NCT02478008
- Testing
- CardiAQ TMVI System (Transapical DS)
- Where
- 9 sites in Denmark, France and 2 more
- Volunteers
- 2 people
- Sponsor
- Edwards Lifesciences
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, Mitral Stenosis
Acute Normovolemic Hemodilution on ROTEM in Cardiac Surgery
Impact of acute normovolemic hemodilution (ANH) using hydroxyethyl starch before initiating cardiopulmonary bypass (CPB) on whole blood viscoelastic profile after CPB has not been well established.
- Conditions
- Mitral Regurgitation, Mitral Stenosis, Tricuspid Regurgitation
- Trial name
- NCT02502448
- Testing
- Acute normovolemic hemodilution (ANH), hydroxyethyl starch (HES 130/0.6)
- Where
- South Korea
- Volunteers
- 70 people
- Sponsor
- Konkuk University Medical Center
Mitral Regurgitation, Mitral Valve Regurgitation
MitraClip NT System Post-marketing Surveillance Study - Japan
The purpose of the MitraClip post-marketing clinical use surveillance study is to observe the frequency, type and degree of adverse device effects and adverse events in order to assure the safety of the new medical device, and to…
- Trial name
- MitraClip NT (NCT03500692)
- Testing
- MitraClip NT System
- Where
- 40 sites in Japan
- Volunteers
- 500 people
- Sponsor
- Abbott Medical Devices
Mitral Regurgitation (MR)
Safety and Feasibility Study of the MitraFix® Transcatheter Mitral Valve System
The goal of this early feasibility clinical trial is to test a new device called the MitraFix® Transcatheter Mitral Valve System.
- Trial name
- MITRA-EFS (NCT07501234)
- Testing
- MitraFix® Transcatheter Mitral Valve System
- Where
- China
- Volunteers
- 5 people
- Sponsor
- Mitrassist Lifesciences Limited Co., Ltd.
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 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 (AU)
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 (AU) (NCT07757698)
- Testing
- Transcatheter mitral valve repair
- Volunteers
- 15 people
- Sponsor
- Polares Medical SA
Mitral Regurgitation, Mitral Insufficiency
Edwards Cardioband European Post-Market Study, MiBAND
To demonstrate reduction of MR with durable performance and im-provements in functional status
- Conditions
- Mitral Regurgitation, Mitral Insufficiency, Mitral Repair, Mitral Valve
- Trial name
- MiBAND (NCT03600688)
- Testing
- Edwards Cardioband System
- Where
- 17 sites in Germany, Italy and 1 more
- Volunteers
- 200 people
- Sponsor
- Edwards Lifesciences
Moderate or Severe Mitral Regurgitation
Novel 3-dimensional Echocardiographic Quantification of Mitral Regurgitant Volume
The goal of this observational study is demonstrate that a novel artificial intelligence based software for the quantification of the mitral regurgitation on 3-dimensional transesophageal echocardiography (3D CFQ) is more…
- Trial name
- AIM_3D (NCT07528781)
- Testing
- analysis of the performance of an artificial intelligenced based software for analysis of 3D tranesophageal echocardiography data
- Where
- Spain
- Volunteers
- 200 people
- Sponsor
- Germans Trias i Pujol Hospital
Mitral Regurgitation, Mitral Valve Disease
Early Feasibility EXperience of Posterior Leaflet RestOration to REduce Mitral Regurgitation
Early feasibility study, single-arm registry design
- Conditions
- Mitral Regurgitation, Mitral Valve Disease, Mitral Valve Insufficiency
- Trial name
- EXPLORE MR (NCT04098328)
- Where
- 3 sites in Germany, Switzerland
- Volunteers
- 2 people
- Sponsor
- Polares Medical SA
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)
Valve Disease, Aortic, Mitral Regurgitation (MR)
DELINEATE-Prospective
Heart disease is the leading cause of death in the United States, and echocardiography (or "echo") is the most common way doctors look at the heart.
- Conditions
- Valve Disease, Aortic, Mitral Regurgitation (MR), Aortic Stenosis, Valvular Heart Disease
- Trial name
- DELINEATE (NCT07197736)
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Columbia University
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 Insufficiency
Multicenter International Trial Ring AnnulopLasty
This clinical study is a multicenter, prospective non-randomized observational study without concurrent or matched controls in which 150 patients receiving an SJM® Rigid Saddle Ring will be included.
- Trial name
- MITRAL (NCT00727012)
- Testing
- mitral valve repair (SJM® Rigid Saddle Ring)
- Where
- Germany
- Volunteers
- 180 people
- Sponsor
- Abbott Medical Devices