Clinical trials: Mitral Valve Disease, active
Mitral Regurgitation Functional, Mitral Valve Disease
A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation
To evaluate the feasibility and safety of the Millipede Transcatheter Annuloplasty Ring System in subjects with functional mitral regurgitation
- Conditions
- Mitral Regurgitation Functional, Mitral Valve Disease, Cardiovascular Diseases
- Trial name
- NCT04147884
- Testing
- Millipede Transcatheter Annuloplasty Ring System (Millipede System)
- Where
- 4 sites in United States, Australia
- Volunteers
- 4 people
- Sponsor
- Boston Scientific Corporation
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
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 Annular Calcification, Mitral Valve Disease
MitrAl Valve Calcium aSsEssmEnt With TrueVue Trans-illumination 3D Rendering.
The study of calcifications involving the mitral valve is extremely important for the planning of both surgical and percutaneous procedures.
- Trial name
- MAC-SEE (NCT07612553)
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Centro Cardiologico Monzino
Mitral Annulus Calcification, Rheumatic Heart Disease
Treating Severe Mitral Valve Annular or Valvular Calcification Using Shockwave Balloon SMARTWAVE
Mitral stenosis (MS) is a heavily symptomatic valvular heart disease. Common causes of MS included chronic rheumatic heart disease (CRHD) and mitral annular calcification (MAC).
- Trial name
- SMARTMAC (NCT06952374)
- Testing
- SmartWave Lithotripsy balloon
- Where
- Hong Kong
- Volunteers
- 10 people
- Sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
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, 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
Valvular Heart Disease
Home-Based Cardiac Rehabilitation Using a Novel Mobile Health Exercise Regimen Following Transcatheter Heart Valve Interventions
The vast majority of cardiac rehabilitation eligible individuals do not participate in center based cardiac rehabilitation (CBCR).
- Trial name
- HOMERUNHITTER (NCT06077201)
- Testing
- HBCR hands-off, HBCR interactive
- Where
- United States
- Volunteers
- 240 people
- Sponsor
- Vanderbilt University Medical Center
Mitral Valve Disease
EXPLORE MRace (BR): Early Feasibility Experience of Posterior Leaflet Restoration to Reduce Mitral Regurgitation Using the MRace Implant
An early feasibility study to evaluate the safety and feasibility of the MRace Implant and Delivery System to treat severe mitral regurgitation and to gather preliminary data on its performance thereby providing guidance for…
- Trial name
- EXPLORE MRace (NCT06113354)
- Testing
- Transcatheter mitral valve repair (MRace Implant and Delivery System)
- Where
- 2 sites in Brazil
- Volunteers
- 10 people
- Sponsor
- Polares Medical SA
Mitral Valve Disease
EXPLORE MRace (GE): Early Feasibility Experience of Posterior Leaflet Restoration to Reduce Mitral Regurgitation Using the MRace Implant
An early feasibility study to evaluate the safety and feasibility of the MRace Implant and Delivery System to treat severe mitral regurgitation and to gather preliminary data on its performance thereby providing guidance for…
- Trial name
- EXPLORE_MRace (NCT07796659)
- Testing
- Transcatheter mitral valve repair (MRace Implant and Delivery System)
- Where
- 4 sites in Georgia
- Volunteers
- 100 people
- Sponsor
- Polares Medical SA
Valvular Heart Disease Patients, Aortic Stenosis
Importance of Point-of-Care Ultrasound for Early Detection of Valvular and Cardiac Diseases (IMPROVE)
Heart valve disease and weakened heart muscle (left ventricular systolic dysfunction) are common in older adults and often go undetected until serious complications such as heart failure develop.
- Conditions
- Valvular Heart Disease Patients, Aortic Stenosis, Mitral Regurgitation, Left Ventricular Diastolic Dysfunction
- Trial name
- IMPROVE (NCT07756398)
- Testing
- Kosmos Torso-One AI-guided Point-of-Care Ultrasound (EchoNous, Inc.)
- Where
- 2 sites in United States
- Volunteers
- 1,088 people
- Sponsor
- University of Texas Southwestern Medical Center
Mitral Regurgitation, Heart Disease
Reduction or Elimination of Mitral Regurgitation With the SATURN TMVR System (CASSINI-US)
CASSINI-US is a prospective, single-arm, multicenter early feasibility study enrolling up to 15 patients at up to 5 sites in the United States (US).
- Trial name
- CASSINI-US (NCT07130994)
- Testing
- Mitral Valve Replacement
- Where
- 5 sites in United States
- Volunteers
- 15 people
- Sponsor
- InnovHeart
Mitral Regurgitation, Mitral Insufficiency
Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation
Prospective, controlled, multicenter clinical investigation with four trial cohorts: Randomized, Non-repairable, Severe Mitral Annular Calcification (MAC) and Severe Mitral Annular Calcification Continued Access Plan (MAC CAP).
- Conditions
- Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Insufficiency, Cardiovascular Diseases
- Trial name
- SUMMIT (NCT03433274)
- Testing
- Tendyne Mitral Valve System, MitraClip System
- Where
- 78 sites in United States, Canada
- Volunteers
- 103 people
- Sponsor
- Abbott Medical Devices
Degenerative Mitral Valve Disease, Mitral Regurgitation
Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve…
- Conditions
- Degenerative Mitral Valve Disease, Mitral Regurgitation, Mitral Insufficiency, Functional Mitral Regurgitation
- Trial name
- CLASP IID/IIF (NCT03706833)
- Testing
- Edwards PASCAL System, Abbott Mitraclip System
- Where
- 81 sites in United States, Canada and 2 more
- Volunteers
- 1,247 people
- Sponsor
- Edwards Lifesciences
Degenerative Mitral Valve Disease
Clinical and Fundamental Aspects of Prosthetics and Translocation of Mitral Valve Chordae
The study compares the efficacies of two surgical procedures for the treatment of mitral valve prolapse due to myxomatous degeneration of the mitral valve: the chordae replacement and the translocation of secondary mitral valve…
- Trial name
- NCT03674593
- Testing
- Mitral valve chordae prosthesis, Mitral valve chordae translocation
- Where
- Russia
- Volunteers
- 64 people
- Sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
Mitral Valve Disease
Management and Clinical Outcomes of Patients With Severe Mitral Valve Disease Not Suitable for Surgery
The objective of this study is to collect in a prospective registry all cases of French patients undergoing an assessment for percutaneous treatment of mitral valve disease on a native valve or due to deterioration after surgical…
- Trial name
- MITRAGISTER (NCT02925819)
- Where
- 3 sites in France
- Volunteers
- 500 people
- Sponsor
- French Cardiology Society
Mitral Valve Regurgitation
Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation
To evaluate the safety and performance of the Tendyne™ Mitral Valve System when used as intended in a contemporary, real-world setting.
- Trial name
- RESOLVE-MR (NCT04818502)
- Testing
- Tendyne™ Mitral Valve System
- Where
- 36 sites in Austria, Belgium and 11 more
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Degenerative Mitral Valve Disease
Transcatheter vs. Surgical Treatment of Degenerative Mitral Regurgitation
The goal of this observational study is to compare the outcomes of transcatheter edge-to-edge repair (TEER) versus surgical mitral valve repair for degenerative mitral regurgitation (DMR) over the long term. The study aims to: 1.
- Trial name
- DMR (NCT07605715)
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Cedars-Sinai Medical Center
Mitral Regurgitation, Tricuspid Regurgitation
Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study
ARB-PMCF is a multicenter, observational study of the safety and performance of Abbott annuloplasty devices used in surgical repair of mitral and tricuspid valve regurgitation.
- Conditions
- Mitral Regurgitation, Tricuspid Regurgitation, Valvular Heart Disease
- Trial name
- ARB-PMCF (NCT04761120)
- Testing
- Abbott SJM Rigid Saddle Ring, Abbott SJM Séguin Ring, Abbott SJM Tailor Ring
- Where
- 17 sites in United States, Estonia and 5 more
- Volunteers
- 550 people
- Sponsor
- Abbott Medical Devices
CAD - Coronary Artery Disease, CABG
Soft Foam Dressings for Pressure Injury Prevention of Cardiac Surgery
The purpose of this study is to evaluate whether the application of soft foam dressings can reduce the occurrence of surgery-related pressure injuries among patients undergoing cardiac surgery.
- Conditions
- CAD - Coronary Artery Disease, CABG, Valve Disease, Heart, Aortic Diseases
- Trial name
- NCT07379294
- Testing
- CONVAFoam Hydrofiber Dressing, Standard Pressure Injury Prevention Care
- Volunteers
- 80 people
- Sponsor
- Shih,Wen-Chi