Clinical trials: Severe Mitral Valve Regurgitation
Degenerative Mitral Regurgitation
FIH ITA Study - Vesalius TMVr System for Symptomatic Degenerative Mitral Regurgitation
This first-in-human study evaluates the safety and performance of the Vesalius Transcatheter Mitral Valve Repair (TMVr) System in patients with degenerative mitral regurgitation.
- Trial name
- NCT07470788
- Testing
- Transcatheter Mitral Valve Repair
- Where
- Canada
- Volunteers
- 5 people
- Sponsor
- Vesalius Cardiovascular Inc.
Mitral Valve Prolapse, Mitral Regurgitation
The Role of cardIac magNeTic rEsonance in surGical Decision Making in Patients With Severe pRimAry miTral rEgurgitation
Mitral regurgitation (MR) is the second most frequent valvular heart disease and the second most frequent indication for valve surgery in Europe.
- Trial name
- INTEGRATE (NCT07366723)
- Testing
- mitral valve surgery, Clinical Follow up
- Where
- Italy
- Volunteers
- 260 people
- Sponsor
- Centro Cardiologico Monzino
Depression, Anxiety, Healthy
Integrins and Protocadherins in Glutamatergic Circuits: Identification of Common Signaling Pathways and Molecular Targets in Anxiety and Major Depressive Disorders (GAPsy)
The aim of this study is to identify biologically viable targets for the treatment of major depressive disorder (MDD) and anxiety disorder (AD) with the ultimate goal of guiding physicians' therapeutic strategies and identifying…
- Trial name
- GAPsy (NCT06167590)
- Testing
- GAPsy protocol
- Where
- Italy
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
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.
Mitral Regurgitation
Early Surgery Versus Conventional Treatment for Asymptomatic Severe Mitral Regurgitation
The timing of surgical intervention in asymptomatic patients with severe degenerative mitral regurgitation (MR) remains controversial.
- Trial name
- NCT01703806
- Testing
- Early Surgery, Watchful Observation
- Where
- 2 sites in South Korea
- Volunteers
- 1,063 people
- Sponsor
- Asan Medical Center
Insomnia, Major Depression
Cortical GABA Concentrations in Insomnia
Disturbances in the amino acid neurotransmitter (AANt), gamma-amino butyric acid (GABA) function are hypothesized to contribute to the neurobiology of Major Depressive Disorder (MDD) and insomnia.
- Trial name
- NCT00765752
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Yale University
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
Mitral Regurgitation
TEER for Severe DMR of Low to Intermediate Surgery Risk
To investigate the efficacy and safety of transcatheter mitral valve edge-to-edge repair (TEER) for severe degenerative mitral regurgitation (DMR) patients of low to intermediate surgery risk.
- Trial name
- NCT06162780
- Testing
- ultrasonic cardiography (UCG), TEER
- Where
- China
- Volunteers
- 160 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Depression, Involutional, Healthy
Serotonin Function During Depression
Serotonin is a chemical involved in regulation of emotions, anxiety, sleep, stress hormones, and other body functions. The purpose of this study is to use a procedure called tryptophan depletion to study the function of serotonin…
- Trial name
- NCT00033787
- Where
- United States
- Volunteers
- 450 people
- Sponsor
- National Institute of Mental Health (NIMH)
Mitral Valve Regurgitation
Hemodynamic Stress Test in Severe Mitral Regurgitation (HEMI)
The preferred treatment of organic mitral regurgitation (MR) is mitral valve repair. Optimally this should be timed so late that it commensurate with the risk of surgery and before irreversibly damage of the heart and pulmonary…
- Trial name
- HEMI (NCT02961647)
- Testing
- Mitral valve repair
- Where
- Denmark
- Volunteers
- 80 people
- Sponsor
- Odense University Hospital
Cardiovascular Diseases
Effectiveness and Safety of Mitral Valve Repair With the NeoChord DS1000 Artificial Chordae Delivery System Versus Conventional Surgery in Patients With Severe Primary Mitral Regurgitation Due to Isolated Leaflet Prolapse
The main objective is to assess the effectiveness and safety of the NeoChord DS1000 repair technique as compared with conventional open-heart on-pump mitral valve surgery in patients with severe primary mitral regurgitation.
- Trial name
- MITRACHORD (NCT02829749)
- Testing
- NeoChord beating heart mitral valve implantation, Control
- Where
- France
- Sponsor
- Hospices Civils de Lyon
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.
Nonvalvular Atrial Fibrillation, Severe Degenerative Mitral Regurgitation
Watchman for Patients With Atrial Fibrillation Undergoing Transcatheter Mitral Valve Repair (WATCH-TMVR)
WATCH-TMVR (Watchman for Patients with Atrial Fibrillation Undergoing Transcatheter Mitral Valve) Clinical Trial have the main objective to assess the feasibility of combining clinically indicated MitraClip TMVR and Watchman LAAO…
- Trial name
- WATCH-TMVR (NCT04494347)
- Testing
- MitraClip TMVR and Watchman LAAO
- Where
- 2 sites in United States, Canada
- Volunteers
- 25 people
- Sponsor
- Mayo Clinic
Degenerative Mitral Valve Disease
Commissural Closure to Treat Severe Mitral Regurgitation: Standing the Test of Time.
Mitral regurgitation (MR) for degenerative disease is nowadays routinely treated with valve repair with excellent short and long term results in experienced centers.
- Trial name
- NCT05774769
- Testing
- Commissural edge to edge mitral valve repair
- Where
- Italy
- Volunteers
- 125 people
- Sponsor
- Michele De Bonis
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.
Mitral Regurgitation Functional
TEER In dynaMic sEvere Functional Mitral Regurgitation (TIMER)
Functional mitral regurgitation is a highly dynamic disease. Some patients exhibit only moderate(2+) functional mitral regurgitation at rest, which deteriorates to moderate-to-severe or severe FMR(3+ or 4+) during stress-termed…
- Trial name
- NCT07197021
- Testing
- TEER, GDMT
- Where
- China
- Volunteers
- 540 people
- Sponsor
- Sun Yat-sen University
Mitral Regurgitation
Feasibility Study of Patients With Severe MR Treated With the Cardiovalve TMVR System
The study will test the safety and performance of the Cardiovalve transfemoral mitral valve replacement system in treating patients with severe mitral regurgitation who are at high risk for open chest surgery.
- Trial name
- NCT03714412
- Testing
- Implantation
- Where
- 2 sites in Greece, Poland
- Sponsor
- Cardiovalve Ltd.
Severe Degenerative Mitral Regurgitation Due to Mid-segment Posterior Leaflet Prolapse
Observational Registry on the HARPOON Device
To collect data on the HARPOON™ Mitral Valve Repair System for use in patients with severe degenerative mitral regurgitation due to posterior leaflet prolapse.
- Trial name
- REPLICATE (NCT04393779)
- Testing
- HARPOON Beating Heart Mitral Valve Repair System (MVRS)
- Where
- 7 sites in Germany, Spain and 1 more
- Volunteers
- 26 people
- Sponsor
- Edwards Lifesciences
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
Atrial Fibrillation (AF), Catheter Ablation
Efficacy and Safety of Catheter abLation in patiEnts With seVere mitrAl regurgiTation and pErsistent Atrial Fibrillation: a Randomized Controlled Trial
Atrial fibrillation (AF) leads to atrial functional mitral regurgitation (MR) through mechanisms including mitral annular dilatation, systolic leaflet motion distance alteration, and contractility decrease.
- Conditions
- Atrial Fibrillation (AF), Catheter Ablation, Atrial Functional Mitral Regurgitation
- Trial name
- ELEVATE-AF (NCT06883864)
- Testing
- Catheter ablation plus medication, Medication, (ELEVATE-AF X) experimental group
- Where
- 17 sites in China
- Volunteers
- 146 people
- Sponsor
- Beijing Anzhen Hospital