Clinical trials: Mitral Valve Insufficiency
Coronary Artery Disease, Arterial Stiffness, Blood Pressure
Expanded Studies on the SCAPIS Stockholm Reexamination Cohort
The Swedish CArdioPulmonary bioImage Study (SCAPIS) is a unique, large-scale national research initiative involving 30,000 randomly selected individuals aged 50-64, recruited between 2014 and 2018.
- Conditions
- Coronary Artery Disease, Arterial Stiffness, Blood Pressure, AORTIC VALVE DISEASES, Mitral Valve Stenosis and/or Insufficiency
- Trial name
- SCAPIS-ReEx (NCT07476703)
- Testing
- Coronary computer tomography (CCTA), Echocardiograhy and aortic ultrasound, Liver elastography
- Where
- Sweden
- Volunteers
- 1,400 people, healthy volunteers welcome
- Sponsor
- Danderyd Hospital
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 Regurgitation
The PALMETTO Study
Prospective, single-arm, multicenter, non-randomized early feasibility study
- Trial name
- PALMETTO (NCT07885839)
- Testing
- ReValve System
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- ReValve Solutions Inc.
Isolated Aortic Stenosis, Mitral Regurgitation
A Study to Evaluate a Computerized Stethoscope Called ©Voqx to Diagnose Heart Disease
The purpose of this study is to determine whether recording heart sounds with an acoustic stethoscope, combined with artificial intelligence (computer information), will show similar abnormalities to an echocardiogram or cardiac…
- Trial name
- NCT04960280
- Testing
- ©VoqX stethoscope
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- Mayo Clinic
Mitral Regurgitation, ATTR-Cardiomyopathy
Edge-to-edge Mitral Valve Repair in ATTR-CM
No previous study has evaluated the effectiveness of transcatheter edge-to-edge mitral valve repair (TEER) in patients with ATTR-associated cardiomyopathy (ATTR-CM) and significant mitral regurgitation, as this specific patient…
- Conditions
- Mitral Regurgitation, ATTR-Cardiomyopathy, Edge-to-Edge Mitral Valve Repair
- Trial name
- MILLENNIAL (NCT06075823)
- Testing
- TEER, Optimal Medical Therapy
- Where
- 10 sites in Austria, Germany and 1 more
- Volunteers
- 106 people
- Sponsor
- Medical University of Vienna
Hypertrophic Cardiomyopathy
Echocardiographic Perspectives on Transient Mitral Regurgitation After Septal Myectomy
Mitral regurgitation (MR) following septal myectomy for hypertrophic obstructive cardiomyopathy may persist despite relief of systolic anterior motion and left ventricular outflow tract obstruction.
- Trial name
- TMRSM_R (NCT07831811)
- Volunteers
- 150 people
- Sponsor
- University Health Network, Toronto
Mitral Regurgitation, Mitral Valve Insufficiency
The ENCIRCLE Trial
This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are…
- Trial name
- ENCIRCLE (NCT04153292)
- Testing
- SAPIEN M3 valve and dock
- Where
- 54 sites in United States, Australia and 4 more
- Volunteers
- 786 people
- Sponsor
- Edwards Lifesciences
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
- 67 sites in United States, Canada and 3 more
- Volunteers
- 450 people
- Sponsor
- Annetine Gelijns
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, Mitral Disease
SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation
This study will evaluate the safety and functionality of the SAPIEN M3 System in patients with symptomatic, severe MR and will provide guidance for future clinical study designs utilizing the SAPIEN M3 System.
- Trial name
- SAPIEN M3 EFS (NCT03230747)
- Testing
- Edwards SAPIEN M3 System
- Where
- 9 sites in United States, Canada
- Volunteers
- 72 people
- Sponsor
- Edwards Lifesciences
Mitral Regurgitation
EFS of the CardioMech MVRS
Safety and performance evaluation of the CardioMech Mitral Valve Repair System (MVRS) in patients with degenerative mitral valve regurgitation.
- Trial name
- NCT04820764
- Testing
- CardioMech MVRS
- Where
- 12 sites in United States
- Volunteers
- 35 people
- Sponsor
- CardioMech AS
Mitral Valve Regurgitation (Degenerative or Functional)
TVMR With the INNOVALVE System Trial - Early Feasibility Study
Study to evaluate the safety and performance of the INNOVALVE system
- Trial name
- TWIST-EFS (NCT04919980)
- Testing
- INNOVALVE system
- Where
- 21 sites in United States
- Volunteers
- 85 people
- Sponsor
- Edwards Lifesciences
Structural Heart Disease, Mitral Valve Regurgitation
The Asia-Pacific Mitral & Tricuspid Valve-in-Valve/Valve-in-Ring Registry
A significant number of patients with severe mitral and tricuspid valve disease have been previously treated with either valve repair with annuloplasty rings or valve replacement with bioprosthetic/mechanical valves.
- Trial name
- AP ViV (NCT07296016)
- Where
- Hong Kong
- Volunteers
- 15 people
- Sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
Mitral Regurgitation, Atrial Fibrillation
Optimal PeriproCeduraL AnticOagulation in Structural Transseptal Interventions
The transcatheter edge to edge mitral valve repair (TEER) and left atrial appendage closure (LAAC) are the interventional cardiology procedures that require periprocedural anticoagulation with unfractionated heparin (UFH).
- Conditions
- Mitral Regurgitation, Atrial Fibrillation, Anticoagulation
- Trial name
- STOP CLOT (NCT05305612)
- Testing
- early anticoagulation, late anticoagulation
- Where
- 5 sites in Poland
- Volunteers
- 410 people
- Sponsor
- National Institute of Cardiology, Warsaw, Poland
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
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 Regurgitation
Cephea Early Feasibility Study
The objective of this study is to evaluate the preliminary safety and effectiveness of the Cephea Mitral Valve System for the treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral…
- Trial name
- NCT05061004
- Testing
- Cephea Mitral Valve System
- Where
- 22 sites in United States, Canada
- Volunteers
- 90 people
- Sponsor
- Abbott Medical Devices
Mitral Regurgitation, Mitral Stenosis
Cephea South America Feasibility Study
The objective of this study is to evaluate the preliminary safety and effectiveness of the Cephea Mitral Valve System for the treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral…
- Trial name
- NCT07244939
- Testing
- Cephea Mitral Valve System
- Where
- 3 sites in Brazil, Chile
- Volunteers
- 20 people
- Sponsor
- Abbott Medical Devices
Atrial Functional Mitral Regurgitation
Safety and Efficacy of Transcatheter Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation
This study is a prospective, randomized, parallel-control, open-label, multicenter clinical trial. Eligible subjects will be randomized in a 1:1 ratio to the Device group (Interventional group) or to no Device group (Control…
- Trial name
- STAR (NCT07414225)
- Testing
- Transcatheter Edge-to-Edge Repair, Guideline-Directed Medical Therapy (GDMT) for cardiovascular disease
- Where
- China
- Volunteers
- 400 people
- Sponsor
- Beijing Anzhen Hospital
Mitral Regurgitation, Mitral Stenosis
Abbott Cephea Mitral Valve Disease Registry
The objective of this registry is to gather clinical data on symptomatic patients with mitral valve disease, including patients with mitral regurgitation, mitral stenosis, and mixed mitral valve disease.
- Conditions
- Mitral Regurgitation, Mitral Stenosis, Mitral Valve Disease, Mitral Valve (MV) Regurgitation
- Trial name
- NCT07069673
- Where
- 24 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Abbott Medical Devices