Clinical trials: Heart Disease, Valvular
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 Regurgitation
Sutra Hemi-valve First-in-Human Study
Study to evaluate the feasibility, safety and performance of the Sutra Hemi-valve Transcatheter Mitral Valve Replacement System in patients with moderate-severe and severe symptomatic mitral regurgitation who are at high risk for…
- Trial name
- NCT06552689
- Testing
- Sutra Hemi-valve Transcatheter Mitral Valve Replacement (TMVR) System
- Where
- New Zealand
- Volunteers
- 15 people
- Sponsor
- Sutra Medical, Inc.
Functional Mitral Regurgitation, Mitral Regurgitation
The CINCH-FMR Post-Market Registry: Percutaneous Repair in Functional Mitral Regurgitation
This is a retrospective and prospective, multi-center, post-market observational registry study. The primary objective of this post market registry is to continue to evaluate the long term safety and performance of the Carillon®…
- Trial name
- CINCH-FMR (NCT05677568)
- Testing
- Carillon Mitral Contour System
- Where
- 19 sites in Germany
- Volunteers
- 250 people
- Sponsor
- Cardiac Dimensions, Inc.
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
Atrial Fibrillation
Real-world Comparative Effectiveness of Apixaban Versus Vitamin K Antagonist
To obtain a better understanding on the comparative effectiveness of apixaban versus VKA (Vitamin K antagonist) for stroke prevention in patients with NVAF (Non-valvular atrial fibrillation) in a real-life setting.
- Trial name
- PIXI-F (NCT02687854)
- Testing
- Apixaban, Vitamin K antagonist
- Where
- United States
- Volunteers
- 18,591 people
- Sponsor
- Bayer
Tricuspid Regurgitation (TR)
A Post-Market Assessment of the Safety and Performance of the TriClip™ System
The objective of the TREAT TR study is to confirm the safety and performance of the TriClip System for tricuspid TEER in a contemporary, real-world setting, using the commercially available device in accordance with its approved…
- Trial name
- TREAT TR (NCT07586995)
- Testing
- Tricuspid Transcatheter Edge-to-Edge Repair (TEER)
- Where
- 9 sites in United States, Germany and 2 more
- Volunteers
- 1,000 people
- Sponsor
- Abbott Medical Devices
Obstructive Hypertrophic Cardiomyopathy
Effect of Verapamil Tablets on the Pharmacokinetic of HRS-1893 Tablets in Healthy Subjects
The purpose of this phase Ⅰ study is to evaluate the effect of oral verapamil tablets on the pharmacokinetics of HRS-1893 in healthy subjects.
- Trial name
- NCT06354556
- Testing
- HRS-1893 tablet, Verapamil tablet
- Where
- China
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Hypertrophic Cardiomyopathy
Effect of Eleclazine (GS-6615) on Exercise Capacity in Subjects With Symptomatic Hypertrophic Cardiomyopathy
The primary objective of this study was to evaluate the effect of eleclazine (GS-6615) on exercise capacity as measured by Peak oxygen uptake (VO2) achieved during cardiopulmonary exercise testing (CPET), in participants with…
- Trial name
- LIBERTY-HCM (NCT02291237)
- Testing
- Eleclazine
- Where
- 46 sites in United States, Australia and 6 more
- Volunteers
- 172 people
- Sponsor
- Gilead Sciences
Mitral Regurgitation
A Feasibility Registry of Actigraphy Monitoring in Degenerative Mitral Regurgitation Subjects Receiving the MitraClip® Device
A prospective, open-label, and multi-centered feasibility registry.
- Trial name
- VELOCITY (NCT02858245)
- Testing
- No intervention - registry
- Where
- 8 sites in United States
- Volunteers
- 30 people
- Sponsor
- Abbott Medical Devices
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
Hypertrophic Cardiomyopathy (HCM)
COLLIGO-HCM: A Multinational Observational Study of the Real-World Effectiveness of Mavacamten Among Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)
COLLIGO-HCM is a global observational study that will conduct observational research of hypertrophic cardiomyopathy (HCM) treatment in real-world clinical practice.
- Trial name
- COLLIGO-HCM (NCT06372457)
- Testing
- Approved Hypertrophic Cardiomyopathy drug treatments, Mavacamten
- Where
- United States
- Volunteers
- 331 people
- Sponsor
- Bristol-Myers Squibb
Aortic Valve Disease
Streamlined One-wire Logistics Optimize Transcatheter Aortic Valve Replacement
The goal of this study is to determine the safety and performance of a new guidewire and pacing system called the Fusion System in treating patients undergoing transcatheter aortic valve replacement (TAVR) or similar procedures.
- Trial name
- SOLO-TAVR (NCT07090811)
- Testing
- Aortic valve repair/replacement
- Volunteers
- 20 people
- Sponsor
- Solo Pace, Inc.
Aortic Valve Stenosis
Medtronic CoreValve Evolut R U.S. Clinical Study (Evolut 34R Addendum)
The study objectives are to assess the safety and efficacy of the CoreValve Evolut 34R transcatheter aortic valve replacement (TAVR) system in patients with severe symptomatic aortic stenosis who are considered at high or extreme…
- Trial name
- NCT02746809
- Testing
- CoreValve Evolut 34R TAVR system
- Where
- 10 sites in United States
- Volunteers
- 72 people
- Sponsor
- Medtronic Cardiovascular
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
Mitral Regurgitation
Expanded Study of the HighLife 28mm Trans-septal Trans-catheter Mitral Valve in Patients With Moderate-severe or Severe Mitral Regurgitation and at High Surgical Risk
to evaluate the safety and performance of the HighLife 28mm transcatheter, trans-septal Mitral Valve in patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment.
- Trial name
- NCT04029363
- Testing
- HighLife Transcatheter Mitral Valve Replacement
- Where
- 50 sites in Australia, Belgium and 5 more
- Volunteers
- 120 people
- Sponsor
- HighLife SAS
Functional Tricuspid Regurgitation, Heart Valve Diseases
Early Feasibility Study of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System
The primary objective of the study is to generate feasibility safety and performance data for the 4Tech TriCinch Coil System in symptomatic patients suffering from moderate to severe functional tricuspid regurgitation with…
- Conditions
- Functional Tricuspid Regurgitation, Heart Valve Diseases, Tricuspid Valve Insufficiency
- Trial name
- NCT03632967
- Testing
- Tricinch Coil System Implantation
- Where
- 9 sites in United States
- Volunteers
- 7 people
- Sponsor
- 4Tech Cardio Ltd.
Aortic Valve Stenosis
A Clinical Evaluation of the HYDRA Self Expanding Transcatheter Aortic Valve
The purpose of this study is the evaluation of the performance, safety and efficacy of Hydra Aortic valve in real-world patients.
- Trial name
- NCT02434263
- Testing
- Hydra TAVI
- Where
- 6 sites in Greece, Hong Kong and 4 more
- Volunteers
- 165 people
- Sponsor
- Vascular Innovations Co. Ltd.
Aortic Valve Disease, Coronary Artery Disease (CAD)
Phase III Study Comparing Two Methods of Cardioplegia in Aortic Valve Surgery Custodiol-N Versus Custodiol
The objective of this investigation is to compare the cardioprotective effects and safety of two cardioplegic solutions, HTK Cardioplegic Solution (Custodiol) and Custodiol-N in patients undergoing aortic valve surgery.
- Trial name
- Custodiol-AV (NCT02098772)
- Testing
- Custodiol-N, Custodiol
- Where
- 6 sites in Germany
- Volunteers
- 530 people
- Sponsor
- Dr. F. Köhler Chemie GmbH
Heart Failure, Cardiomyopathies
Multimodal Physiologic State Intelligence Study
The OMNIPHYS study will investigate whether multimodal ultrasound and other routinely collected clinical and physiologic data can be combined with artificial intelligence to characterize changes in a person's physiologic state…
- Conditions
- Heart Failure, Cardiomyopathies, Pulmonary Hypertension, Myocarditis; Acute or Subacute
- Trial name
- OMNIPHYS (NCT07814118)
- Testing
- OMNIPHYS Multimodal Ultrasound Imaging System
- Where
- United States
- Volunteers
- 25,000 people, healthy volunteers welcome
- Sponsor
- Truway Health, Inc.
Symptomatic Severe Native Aortic Stenosis, Aortic Stenosis
STAR Trial (Siegel Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis)
To evaluate the safety and efficacy of Siegel™ TAVR System in the treatment of subjects with symptomatic severe native aortic stenosis.
- Trial name
- NCT07278310
- Testing
- TAVR Device, Siegel TAVR Device
- Where
- United States
- Volunteers
- 1,025 people
- Sponsor
- MiRus