Clinical trials: Artificial Heart Valve
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
Para-prosthetic Heart
Para-Prosthetic Valve Leak Closure Observatory - PVLC2
Para-prosthetic heart valve leakage is an evolving complication after surgical or percutaneous heart valve replacement. These leaks can lead to heart failure and/or life-threatening hemolysis.
- Trial name
- FFPP2 (NCT07049991)
- Testing
- surgical or percutaneous heart valve replacement.
- Where
- France
- Volunteers
- 300 people
- Sponsor
- Fondation Hôpital Saint-Joseph
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 Stenosis, Disorder of Prosthetic Cardiac Valve
Biomarkers in Aortic Stenosis - B.A.S.S.
This study is being done to determine whether or not new blood test(s) can determine the severity of heart conditions. Aortic stenosis, hypertrophic cardiomyopathy, mitral regurgitation, aortic regurgitation, artificial heart…
- Conditions
- Aortic Stenosis, Disorder of Prosthetic Cardiac Valve, Aortic Valve Insufficiency, Mitral Valve Insufficiency
- Trial name
- BASS (NCT01334801)
- Testing
- Blood Draw
- Where
- United States
- Volunteers
- 378 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
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.
Low-gradient Aortic Stenosis, Aortic Stenosis
AI Assessment of Low-Gradient Aortic Stenosis Severity Based on Echocardiography
The purpose of this study is to evaluate the effectiveness of an artificial intelligence (AI) model developed by the investigators for identifying severe low-gradient aortic valve stenosis.
- Trial name
- ASAI-POL (NCT07144189)
- Testing
- AI diagnostic test for severe low-gradient aortic stenosis
- Where
- Poland
- Volunteers
- 300 people
- Sponsor
- National Institute of Cardiology, Warsaw, Poland
Diseases of Mitral and Aortic Valves, Rheumatic Disorders of Mitral and Aortic Valves
Study on Efficacy, Safety and Durability of the UniLine Prosthesis in the Treatment of Aortic and Mitral Valve Disease
Acquired heart diseases continue to remain one of the most common causes of cardiac mortality and morbidity. In the Russian Federation, open surgery treatment of acquired valvular heart diseases (AVHD) is performed in more than…
- Conditions
- Diseases of Mitral and Aortic Valves, Rheumatic Disorders of Mitral and Aortic Valves, Other Congenital Malformations of Aortic and Mitral Valves, Valvular Heart Disease (Aortic and Mitral Valves)
- Trial name
- NCT05895487
- Where
- Russia
- Volunteers
- 2,000 people
- Sponsor
- Closed Joint-Stock Company NeoCor
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
Heart Valve Diseases
Patients Perception of Mechanical Heart Valve Sounds: Psychoacoustics and Quality of Life
The purpose of this study is to compare the sound pressure levels (SPLs) from three of the most frequently implanted mechanical heart valve prostheses, in order to determine whether there was any significant difference between…
- Trial name
- NCT00362401
- Where
- Germany
- Volunteers
- 90 people
- Sponsor
- University of Aarhus
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
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
Valvular Heart Disease
Age and Sex-Specific PREValence of AcqUirEd VALVular Heart DiseasE
The PREVUE-VALVE study will establish reliable, population-based estimates of Valvular Heart Disease (VHD) prevalence among older Americans and allow for the development and validation of several innovative tools to aid in the…
- Trial name
- PREVUE-VALVE (NCT05357404)
- Where
- United States
- Volunteers
- 2,870 people, healthy volunteers welcome
- Sponsor
- Cardiovascular Research Foundation, New York
CVD
EEG/MECG/EMG Evaluating the Severity of Aortic Stenosis, Heart Failure and Ischemic Stroke Through an Artificial Intelligenceassisted System.
The specific objectives and methods of this project are: (1) To test the feasibility and accuracy of integrating EEG, MECG and EMG for detecting the severity of diseases such as aortic stenosis, heart failure and ischemic stroke.
- Trial name
- NCT05716659
- Where
- Taiwan
- Volunteers
- 750 people, healthy volunteers welcome
- Sponsor
- National Taiwan University Hospital
Murmur, Heart, Aortic Valve Stenosis
Development of an Algorithm to Differentiate Heart Murmurs Using Electronic Stethoscopes
The Eko CORE and DUO stethoscopes are FDA-approved electronic devices that have the capacity to record heart sounds. The study seeks to expand murmur detection to include VHD classification through the development of novel ML…
- Conditions
- Murmur, Heart, Aortic Valve Stenosis, Tricuspid Regurgitation, Mitral Regurgitation
- Trial name
- NCT04400513
- Testing
- Use of Eko CORE and Eko DUO electronic stethoscopes
- Where
- United States
- Volunteers
- 1,145 people
- Sponsor
- Eko Devices, Inc.
Valvular Heart Disease
Evaluation of an Automated Smartphone-based Digital Auscultation Application for Detecting Abnormal Heart Sounds Using Deep Learning Techniques
This pilot study is to investigate the feasibility of obtaining medical grade audio phonocardiogram (PCG) recordings using a smartphone-based auscultation device in the first step.
- Trial name
- AVDA (NCT05325723)
- Where
- Switzerland
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- University Hospital, Basel, Switzerland
Coronary Artery Bypass Grafting, Heart Valve Disease
LLM-Based Intelligent Health Management Assistant in Life-Cycle Health Management of Cardiac Surgery Patients
This is a single-center, prospective, randomized, open-label, parallel-controlled clinical study to evaluate the effectiveness of a large language model (LLM)-based intelligent health management assistant in the life-cycle health…
- Conditions
- Coronary Artery Bypass Grafting, Heart Valve Disease, Aortic Aneurysm, Aortic Dissection
- Trial name
- cFT-LLM (NCT07521488)
- Testing
- LLM-Based Intelligent Health Management Assistant
- Where
- China
- Volunteers
- 500 people
- Sponsor
- Beijing Anzhen Hospital
Aortic Stenosis
Multicenter Study for the Validation of Willem AI: Aortic StenoSis Early Diagnosis With AI-electrocardiogram Study
AoS-SEDAI study is an observational, multicenter, retrospective and prospective clinical study. This study aims to assess Willem Artificial Intelligence (AI) ability to distinguish between aortic stenosis (AS) and non-AS patients…
- Trial name
- AoS-SEDAI (NCT07479992)
- Testing
- Willem AI ECG assessment
- Where
- 2 sites in Germany
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Idoven 1903 S.L.
Atrial Fibrillation
The Home INR Study
Since home monitors of prothrombin time (PT) may potentially improve the safety, quality, and convenience of chronic anticoagulation management, it is likely that there will be demands from providers, patients, and manufacturers…
- Trial name
- THINRS (NCT00032591)
- Testing
- Weekly patient self-testing of prothrombin time, High quality anticoagulation management (HQACM) with conventional monthly testing
- Where
- 29 sites in United States, Puerto Rico
- Volunteers
- 2,922 people
- Sponsor
- US Department of Veterans Affairs