Clinical trials: Artificial Heart Valve
Aortic Valve Disease, Mitral Valve Disease
Artificial Valve Endocarditis Reduction Trial
The purpose of this study is to investigate whether the Silzone coated sewing cuff reduces the incidence of prosthetic valve endocarditis (PVE).
- Conditions
- Aortic Valve Disease, Mitral Valve Disease, Endocarditis
- Trial name
- AVERT (NCT00590889)
- Testing
- Artificial Mechanical Heart Valve
- Where
- 16 sites in United States, Canada and 6 more
- Volunteers
- 807 people
- Sponsor
- Abbott Medical Devices
Tricuspid Regurgitation (TR)
LuX-Valve Plus System for Severe or Greater Tricuspid Regurgitation
This clinical trial aims to evaluate the safety and effectiveness of the Transvenous Artificial Tricuspid Valve System, LuX-Valve Plus System, Jenscare Scientific Co., Ltd.
- Trial name
- NCT07705594
- Testing
- Transvenous Tricuspid Valve System implantation + OMT, OMT
- Where
- China
- Volunteers
- 126 people
- Sponsor
- Jenscare Scientific
Paravalvular Aortic Regurgitation
PARADIGM: Amplatzer Valvular Plug for PVL Closure
The Paradigm study is a prospective, multicenter, single arm study to demonstrate the safety and effectiveness of the Amplatzer Valvular Plug III (AVP III) as a treatment for clinically significant PVLs following surgical implant…
- Trial name
- PARADIGM (NCT04489823)
- Testing
- AVP III
- Where
- 24 sites in United States, Canada and 5 more
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
AORTIC VALVE DISEASES, Mitral Valve Disease
Early Feasibility Study of Surgical Implantation of a Polymer Prosthetic Mitral and Aortic Valve
The goal of this clinical trial is to explore the early feasibility, initial safety, and efficacy of surgical implantation of a polymer prosthetic heart valve in patients requiring either mitral valve replacement or aortic valve…
- Conditions
- AORTIC VALVE DISEASES, Mitral Valve Disease, Aortic Stenosis, Aortic Regurgitation
- Trial name
- POLYVALVE-FIH (NCT07097740)
- Testing
- Polymer Prosthetic Heart Valve
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Mitrassist Lifesciences Limited Co., Ltd.
Mitral Valve Regurgitation, Mitral Valve Prolapse
CE Mark Study for the Harpoon Medical Device in Poland
The purpose of this study is to evaluate the safety and performance of the Harpoon Medical TSD-5. The Harpoon device will provide many significant advantages over current surgical interventions including: 1) a small minimally…
- Conditions
- Mitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency
- Trial name
- NCT02432196
- Testing
- Harpoon Medical Device
- Where
- 2 sites in Poland
- Volunteers
- 26 people
- Sponsor
- Edwards Lifesciences
Psychological Stress, Cardiopulmonary Bypass Surgery
CARINAE for Stress Relief in Perioperative Care
Preventing pre-surgical stress can help patients achieve positive outcomes on health and well-being. However, very few patients receive adequate stress relief support prior to a surgical procedure.
- Conditions
- Psychological Stress, Cardiopulmonary Bypass Surgery, Coronary Artery Bypass Surgery, Cardiac Valve Replacement
- Trial name
- CARINAE (NCT05184725)
- Testing
- SaMD CARINAE
- Where
- 5 sites in Italy, Netherlands and 1 more
- Volunteers
- 50 people
- Sponsor
- Adhera Health, Inc.
Valve Heart Disease
Post-surgical Aortic Hemodynamics After Aortic Valve Replacement
The purpose of this pilot study is to obtain both near valve and downstream flow characteristics, using 3D transthoracic echocardiography and 4D flow MRI respectively, in an existing patient population at Northwestern Memorial…
- Trial name
- NCT03347851
- Testing
- MRI, Transthoracic echocardiography exam
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- CryoLife, Inc.
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.
Mitral Valve Regurgitation, Mitral Valve Prolapse
CE Mark Study for the Harpoon Medical Device
The purpose of this study is to evaluate the safety and performance of the Harpoon Medical device. It is anticipated, that the Harpoon Medical device will provide advantages over current surgical interventions including: 1) a…
- Conditions
- Mitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency
- Trial name
- TRACER (NCT02768870)
- Testing
- Harpoon Artificial ePTFE Chords
- Where
- 4 sites in Italy, United Kingdom
- Volunteers
- 26 people
- Sponsor
- Edwards Lifesciences
Severe Aortic Stenosis, Aortic Regurgitation
Evaluate the Transcatheter Artificial Aortic Valve and Transcatheter Artificial Heart Values Delivery System
The purpose of this study is to demonstrate that transcatheter artificial aortic valve and transcatheter artificial heart values delivery system is associated with a reduction of all-cause mortality in severe aortic stenosis or…
- Trial name
- TAVI (NCT03788590)
- Testing
- Jenscare TAVI
- Volunteers
- 133 people
- Sponsor
- Ningbo Jenscare Biotechnology Co., Ltd.
Paravalvular Leak
A Multicenter, International, Prospective and Retrospective, Follow-up Registry to Monitor the Efficacy and Safety of the Occlutech Paravalvular Leak Device (PLD) in Patients With Mitral or Aortic Paravalvular Leaks
This is an international, multicenter, retrospective and prospective post-marketing follow-up registry designed to monitor the safety and efficacy of the Occlutech Paravalvular Leak Device (PLD) in patients with clinically…
- Trial name
- PLD REGISTRY (NCT07037446)
- Testing
- Transcatheter paravalvular leak closure device
- Where
- 22 sites in France, Germany and 4 more
- Volunteers
- 200 people
- Sponsor
- Occlutech International AB
AORTIC VALVE DISEASES, Aortic Valve Stenosis
Clinical Investigation for the PoliaValve Aortic Heart Valve- India
The purpose of this study is to conduct a clinical investigation of the HeartHill PoliaValve Aortic Valve to collect evidence on the device's safety and performance.
- Conditions
- AORTIC VALVE DISEASES, Aortic Valve Stenosis, Aortic Valve Regurgitation
- Trial name
- NCT07123766
- Testing
- PoliaValve (Aortic)
- Volunteers
- 50 people
- Sponsor
- Suzhou Hearthill Medical Technology Co.,LTD
Aortic Valve Stenosis, Aortic Valve Disease
Clinical Trial Evaluating the Safety and Efficacy of Artificial Polymer Heart Valve for the Treatment of Aortic Valve Disease
The purpose of this study is to conduct the clinical investigation of the HeartHill Medical's polymer aortic valve, namely PoliaVavle，to collect evidence on the device's safety and performance.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Disease, Aortic Valve Regurgitation
- Trial name
- NCT06737757
- Testing
- Artificial polymer heart valves, Bovine pericardial aortic valve
- Volunteers
- 198 people
- Sponsor
- Suzhou Hearthill Medical Technology Co.,LTD
Mitral Valve Regurgitation, Mitral Valve Prolapse
Safety and Performance Study of the Harpoon Mitral Valve Repair System
The primary objective of this study is to evaluate the safety and performance of the Harpoon Medical Device. It is anticipated, that the Harpoon Medical Device will provide advantages over current surgical interventions…
- Conditions
- Mitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency
- Trial name
- NCT03285724
- Testing
- Harpoon Artificial ePTFE Chords
- Where
- 2 sites in Poland
- Volunteers
- 1 people
- Sponsor
- Edwards Lifesciences
Mitral Valve Insufficiency, Mitral Valve Prolapse
European FIH Study - NeoChord Transcatheter Mitral Repair System for Symptomatic Mitral Regurgitation
Safety and performance evaluation of the NeoChord Transcatheter Mitral Repair System in patients with degenerative mitral valve regurgitation.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Prolapse, Degenerative, Mitral Regurgitation
- Trial name
- NCT05425628
- Testing
- NeoChord Transcatheter Mitral Repair System (or "NeoChord System")
- Volunteers
- 30 people
- Sponsor
- NeoChord
Mitral Valve Regurgitation, Mitral Valve Prolapse
Safety and Early Feasibility Study of the Harpoon Medical Device (EFS)
The purpose of this study is to evaluate the safety and performance of the Harpoon Medical TSD-5. The Harpoon device will provide many significant advantages over current surgical interventions including: 1) a small minimally…
- Conditions
- Mitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency
- Trial name
- EFS (NCT02771275)
- Testing
- Harpoon Medical Device
- Where
- 2 sites in Poland
- Volunteers
- 13 people
- Sponsor
- Edwards Lifesciences
Heart Valve Disease
Prospective Randomized On-X Versus SJM Evaluation Trial
The study hypothesizes that rate of thromboembolic complications of the On-X prosthesis is reduced as compared to the SJM prosthesis.
- Trial name
- PROSE (NCT00639782)
- Testing
- On-X Heart valve replacement, SJM Heart valve replacement
- Where
- 28 sites in United States, Australia and 7 more
- Volunteers
- 857 people
- Sponsor
- On-X Life Technologies, Inc.
Aortic Valve Disease, Mitral Valve Disease, Prosthetic Heart Valve Dysfunction, Valvular Heart Disease Requiring Surgical Aortic or Mitral Valve Replacement
Safety and Performance of Dafodil Heart Valves in Real-World Aortic and Mitral Valve Replacement
This study, called the EuroDafodil Registry, is being conducted to understand how safe and effective the Dafodil™ and Dafodil Neo™ Pericardial Bioprosthetic heart valves are when used in routine medical practice.
- Trial name
- NCT07379112
- Testing
- Dafodil™ / Dafodil Neo™ Pericardial Bioprosthetic Heart Valve
- Volunteers
- 500 people
- Sponsor
- Meril Life Sciences Pvt. Ltd.
Thromboembolism, Heart Valve Prosthesis
Follow on Study From RE-ALIGN
To collect additional data relating to safety and indicators of efficacy for patients who have participated in the 1160.113 study.
- Trial name
- NCT01505881
- Testing
- dabigatran etexilate low dose, warfarin 5mg, dabigatran etexilate intermediate dose
- Where
- 30 sites in Belgium, Canada and 7 more
- Volunteers
- 158 people
- Sponsor
- Boehringer Ingelheim
Atrial Fibrillation, Atrial Flutter
Comparison of ATI-5923, a Novel Vitamin K Antagonist, With Warfarin in Patients Requiring Chronic Anticoagulation
The purpose of this research study is to test an experimental drug ATI-5923 vs Coumadin. The study is intended to demonstrate ATI-5923 is superior to Coumadin for keeping INR values in the desired therapeutic range.
- Conditions
- Atrial Fibrillation, Atrial Flutter, Venous Thromboembolic Disease, Myocardial Infarction
- Trial name
- EmbraceAC (NCT00691470)
- Testing
- ATI-5923, Coumadin (warfarin)
- Where
- 41 sites in United States
- Volunteers
- 600 people
- Sponsor
- ARYx Therapeutics