Clinical trials: Valvular Heart Diseases
Mitral Valve Insufficiency, Mitral Valve Regurgitation
Pivotal Study of a Percutaneous Mitral Valve Repair System
EVEREST II Randomized Controlled Trial (RCT) is a prospective, multi-center, randomized study of the MitraClip® System in the treatment of mitral valve regurgitation, randomizing patients to MitraClip or mitral valve surgery.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation
- Trial name
- EVERESTIIRCT (NCT00209274)
- Testing
- Percutaneous mitral valve repair using MitraClip implant, Mitral valve repair or replacement surgery
- Where
- United States
- Volunteers
- 279 people
- Sponsor
- Abbott Medical Devices
Mitral Valve Insufficiency, Heart Valve Diseases
NeoChord TACT Post-Market Surveillance Registry
To monitor the long-term performance of the CE Marked NeoChord Artificial Chordae Delivery System
- Conditions
- Mitral Valve Insufficiency, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases
- Trial name
- NCT01784055
- Where
- 7 sites in France, Germany and 3 more
- Volunteers
- 126 people
- Sponsor
- NeoChord
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.
Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency
Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve
The purpose of the clinical study is to prove that the heart valve device is safe, effective, and performs as intended.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence
- Trial name
- TRANSFORM™ (NCT01700439)
- Testing
- EDWARDS INTUITY valve
- Where
- 29 sites in United States
- Volunteers
- 934 people
- Sponsor
- Edwards Lifesciences
Symptomatic Degenerative Aortic Stenosis, Severe Aortic Stenosis
CONFIDENCE Registry to Assess Safety and Performance of Portico System to Treat Patients With Severe Aortic Stenosis.
The purpose of this clinical investigation is to characterize the procedural safety and device performance of transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in patients with symptomatic degenerative…
- Trial name
- NCT03752866
- Testing
- Portico™ Valve, Portico Delivery System(s) and Loading System(s), Portico™ Valve, FlexNav Delivery System(s) and Loading System(s)
- Where
- 28 sites in Australia, Belgium and 7 more
- Volunteers
- 1,001 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Stenosis
Radiation Following Percutaneous Balloon Aortic Valvuloplasty to Prevent Restenosis
The objective of the RADAR trial is to determine the impact of External Beam Radiation Therapy (EBRT) on aortic valve restenosis following successful percutaneous balloon aortic valvuloplasty (BAV) in elderly patients with severe…
- Trial name
- RADAR (NCT00538759)
- Testing
- External beam radiation therapy
- Where
- 2 sites in United States
- Volunteers
- 21 people
- Sponsor
- Minneapolis Heart Institute Foundation
Mitral Regurgitation, Mitral Insufficiency
Feasibility Study of the Tendyne Mitral Valve System in Mitral Annular Calcification
This study is a prospective, single-arm, multi-center feasibility clinical study of the Tendyne Mitral Valve System for the treatment of eligible subjects with symptomatic, severe mitral regurgitation and severe mitral annular…
- Conditions
- Mitral Regurgitation, Mitral Insufficiency, Mitral Annular Calcification, Mitral Annulus Calcification
- Trial name
- NCT03539458
- Testing
- Tendyne Mitral Valve System
- Where
- 4 sites in United States
- Volunteers
- 11 people
- Sponsor
- Abbott Medical Devices
Hypertrophic Cardiomyopathy (HCM)
Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CK-3773274 in Adults With Hypertrophic Cardiomyopathy
This study is being performed to understand the effect of different doses of CK-3773274 on patients with hypertrophic cardiomyopathy (HCM).
- Trial name
- REDWOOD-HCM (NCT04219826)
- Testing
- CK-3773274 (5 - 15 mg), CK-3773274 (10 - 30 mg)
- Where
- 22 sites in United States, Italy and 2 more
- Volunteers
- 96 people
- Sponsor
- Cytokinetics
Cardiomyopathy, Cardiovascular Diseases
Improving Mitral Repair for Functional Mitral Regurgitation
The investigators are interested in determining the best surgical technique to correct functional mitral regurgitation, as there is currently not one technique that is established to work better than the other.
- Conditions
- Cardiomyopathy, Cardiovascular Diseases, Congestive Heart Failure, Coronary Artery Disease
- Trial name
- IMPROVE-FMR (NCT03366649)
- Testing
- Undersizing Mitral Annuloplasty, Papillary Muscle Approximation
- Where
- 3 sites in United States
- Volunteers
- 34 people
- Sponsor
- Emory University
Bicuspid Aortic Valve
Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study
The objective of the trial is to evaluate the procedural safety and efficacy of the Medtronic TAVR system in patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR
- Trial name
- NCT03635424
- Testing
- Medtronic TAVR Systems
- Where
- 25 sites in United States
- Volunteers
- 150 people
- Sponsor
- Medtronic Cardiovascular
Atrial Fibrillation, Stroke
DU-176b Phase 2 Dose Finding Study in Subjects With Non-valvular Atrial Fibrillation
This study will be conducted in male and female subjects aged 18 to 80 years, inclusive, with non-valvular AF and a CHADS2 Score of at least 1. Subjects will be treated on an outpatient basis.
- Trial name
- NCT00806624
- Testing
- DU-176b tablets, Warfarin tablets
- Where
- 4 sites in China, Singapore and 2 more
- Volunteers
- 234 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Aortic Valve Disorder
CO2 Versus Lund De-airing Technique in Heart Surgery
To evaluate which of the two de-airing methods (CO2 insufflation vs. Lund de-airing technique) can shorten the left heart de-airing time and prevent or minimize cerebral air emboli during open surgery involving exposure of the…
- Trial name
- NCT00934596
- Testing
- Lund de-airing technique, carbon-dioxide insufflation
- Volunteers
- 20 people
- Sponsor
- Lund University
Tricuspid Valve Regurgitation
The SPACER Trial - Repair of Tricuspid Valve Regurgitation Using the Edwards TricuSPid TrAnsCatheter REpaiR System
The purpose of the study is to assess the safety and device performance of the Edwards Tricuspid Transcatheter Repair System in patients with clinically significant, symptomatic, tricuspid regurgitation who are at high surgical…
- Trial name
- SPACER (NCT02787408)
- Testing
- EW Tricuspid Transcatheter Repair System
- Where
- 11 sites in Canada, France and 3 more
- Volunteers
- 25 people
- Sponsor
- Edwards Lifesciences
Atrial Fibrillation
Investigational Device Evaluation of the WATCHMAN FLX™ LAA Closure Technology
The study is a prospective, non-randomized, multi-center investigation to establish the safety and effectiveness of the WATCHMAN FLX™ Left Atrial Appendage Closure Device for subjects with non-valvular atrial fibrillation who are…
- Trial name
- PINNACLE FLX (NCT02702271)
- Testing
- WATCHMAN FLX
- Where
- 29 sites in United States
- Volunteers
- 458 people
- Sponsor
- Boston Scientific Corporation
Aortic Valve Stenosis, Heart Valve Diseases
JENAVALVE AS EFS TRIAL: Pericardial TAVR Aortic Stenosis Study
To collect information about treatment for severe aortic stenosis (AS), which affects the aortic valve in the heart. Aortic stenosis is a narrowing of the aortic valve opening, which decreases blood flow from the heart and causes…
- Conditions
- Aortic Valve Stenosis, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases
- Trial name
- NCT02732691
- Testing
- JenaValve Pericardial TAVR System
- Where
- 13 sites in United States, Germany and 2 more
- Volunteers
- 68 people
- Sponsor
- JenaValve Technology, Inc.
Atrial Fibrillation
Phase 2 Study of the Safety, Tolerability and Pilot Efficacy of Oral Factor Xa Inhibitor Betrixaban Compared to Warfarin
Prevention of stroke in patients with atrial fibrillation (AF). Hypothesis: In patients with non-valvular AF, orally administered betrixaban will provide similar or better efficacy and safety than warfarin and it will offer the…
- Trial name
- EXPLORE-Xa (NCT00742859)
- Testing
- betrixaban, Warfarin
- Where
- 21 sites in United States, Canada
- Volunteers
- 508 people
- Sponsor
- Portola Pharmaceuticals
Aortic Valve Stenosis
Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement
Transcatheter aortic valve replacement (TAVR) is a minimally invasive procedure for older adults with severe symptomatic aortic stenosis who are considered high risk for surgical aortic valve replacement.
- Trial name
- REHAB-TAVR (NCT02805309)
- Testing
- Exercise, Cognitive behavioral interventions, Attention control education program
- Where
- 3 sites in United States
- Volunteers
- 64 people
- Sponsor
- Brigham and Women's Hospital
Aortic Valve Stenosis
Medtronic CoreValve REDO Study
The proposed investigation is a prospective, multicenter, non-randomized study to evaluate the immediate benefits (at discharge and at 30 days) in terms of performance and safety of the implantation of the Medtronic CoreValve PAV…
- Trial name
- REDO (NCT01051310)
- Testing
- Medtronic CoreValve System
- Where
- 3 sites in Germany, Netherlands
- Volunteers
- 18 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Valvular Heart Disease, Aortic Valve Failure
NHLBI Transmural Electrosurgery LeafLet Traversal And Laceration Evaluation (TELLTALE) BASILICA-TAVR Trial
Background: Replacing a valve in the heart can save many people's lives. The procedure is called transcatheter aortic valve replacement (TAVR).
- Trial name
- NCT05666713
- Testing
- TELLTALE BASILICA procedure
- Where
- 10 sites in United States
- Volunteers
- 90 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Aortic Valve Stenosis, Cardiovascular Diseases
Comparison of a Rivaroxaban-based Strategy With an Antiplatelet-based Strategy Following Successful TAVR for the Prevention of Leaflet Thickening and Reduced Leaflet Motion as Evaluated by Four-dimensional, Volume-rendered Computed Tomography (4DCT)
The aortic valve is located between the left ventricle and the aorta. Patients with symptomatic, severe aortic valve stenosis conventionally have it surgically replaced requiring direct access to the heart through the chest.
- Conditions
- Aortic Valve Stenosis, Cardiovascular Diseases, Heart Valve Diseases, Ventricular Outflow Obstruction
- Trial name
- GALILEO-4D (NCT02833948)
- Testing
- Acetylsalicylic acid, Clopidogrel, Rivaroxaban
- Where
- 25 sites in United States, Canada and 5 more
- Volunteers
- 231 people
- Sponsor
- ECRI bv