Clinical trials: Artificial Heart Valve
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.
Cardiac Pacing, Artificial, Tricuspid Valve Regurgitation, Non-rheumatic
Cardiac Implantable Electronic Device- Induced Remodelling of Tricuspid Valve and Right Chambers
This single-center longitudinal study aims to evaluate the occurrence and clinical impact of tricuspid regurgitation (TR) after cardiac-implanted-electronic-device (CIED) implantation by comprehensive echocardiographic…
- Trial name
- CIED-REMTRIC (NCT06914570)
- Where
- Italy
- Volunteers
- 350 people
- Sponsor
- Istituto Auxologico Italiano
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
Anticoagulation in Pregnancy
Safety And Efficacy of Low Dose Oral Anticoagulants And Aspirin Therapy
A prospective, randomized, longitudinal, open label, parallel group clinical trial was designed to compare the proportions of failure to reach INR target 2.5-3.5 with either: small dose warfarin (<5 mg/day) or phenindione (<100…
- Trial name
- NCT01758640
- Testing
- Warfarin, phenindione
- Where
- Egypt
- Volunteers
- 200 people
- Sponsor
- Yasser Elnahas
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.
Healthy Adults, Pulmonary Hypertension
A Multicenter Study on the Normal Reference Range and Clinical Significance of the Right Atrioventricular Coupling Index Assessed by Artificial Intelligence-Based Three-Dimensional Echocardiography
This multicenter study aims to establish the normal reference range of the Right Atrioventricular Coupling Index (RACI) in healthy Chinese adults using AI-based 3DE technology.
- Conditions
- Healthy Adults, Pulmonary Hypertension, Tricuspid Regurgitation, Heart Failure
- Trial name
- NCT07292896
- Where
- 25 sites in China
- Volunteers
- 2,640 people, healthy volunteers welcome
- Sponsor
- First Hospital of China Medical University
Postoperative Delirium, Heart Valve Diseases
Transcranial Doppler and Artificial Intelligence Prediction of Postoperative Delirium in Heart Valve Surgery
Postoperative delirium is a frequent complication after cardiac surgery. This prospective observational study will evaluate whether cerebral blood flow velocity measured by transcranial Doppler before and during elective heart…
- Trial name
- NCT07858578
- Where
- Turkey (Türkiye)
- Volunteers
- 120 people
- Sponsor
- Osman Sila Aydin
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
Male Infertility, Heart Valve Disease
Warfarin Effects on Male Fertility After Cardiac Surgery
Young male patients undergoing cardiac surgery may require oral anticoagulation with warfarin either lifelong, such as after mechanical valve replacement, or for a limited postoperative period, for example following valve repair…
- Trial name
- NCT07330869
- Testing
- Semen analysis, sperm DNA fragmentation and hormonal evaluation
- Where
- Italy
- Volunteers
- 90 people
- Sponsor
- Città di Lecce Hospital, GVM Care & Research
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
Valvular Heart Disease Patients
Rivaroxaban vs Warfarin in Patients With Mechanical Heart Valves
Warfarin is the standard anticoagulant used for patients with mechanical heart valves; however, its use is complicated by a narrow therapeutic window, frequent drug and dietary interactions, and the need for regular international…
- Trial name
- NCT07456085
- Testing
- Rivoroxaban, Warfarin
- Where
- Pakistan
- Volunteers
- 60 people
- Sponsor
- Rawalpindi Institute of Cardiology
Left-sided Prosthetic Heart Valve Thrombosis
Surgery Versus Fibrinolytic Therapy for Left-sided Prosthetic Heart Valve Thrombosis
Malfunction of mechanical heart valves due to clot formation is a potentially devastating complication. It often results in heart failure, death or stroke.
- Trial name
- SAFE-PVT (NCT01641549)
- Testing
- Emergency surgery, Fibrinolytic therapy
- Where
- India
- Volunteers
- 115 people
- Sponsor
- All India Institute of Medical Sciences
Hypertrophic Cardiomyopathy (HCM), Left Ventricular Hypertrophy
AI-Enabled Diagnosis and Prognosis of Hypertrophic Cardiomyopathy
By harnessing artificial intelligence to decode the 12-lead electrocardiogram, the project will enable precise ECG-based phenotyping of hypertrophic cardiomyopathy-accurately classifying septal, apical, and other morphologic…
- Trial name
- NCT07263204
- Where
- China
- Volunteers
- 15,000 people, healthy volunteers welcome
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Mitral Regurgitation
Artificial Intelligence Assisting Transcatheter Mitral Edge-to-Edge Repair
This multicenter, retrospective study develops and validates artificial intelligence (AI)-based semantic segmentation algorithms for intraprocedural transesophageal echocardiography (TEE) during Transcatheter Mitral Edge-to-Edge…
- Trial name
- AutoClip (NCT07632794)
- Where
- 3 sites in China, Italy
- Volunteers
- 1,500 people
- Sponsor
- Mi Chen
Aortic Valve Disease, Pulmonary Valve Disease
Artificial Intelligence in New Cardiac MR Markers for Congenital Heart Disease
The goal of this study is to investigate children with aortic and pulmonary valve disease treated or untreated longitudinally. Established CMR measures with additional newly developped, promising, highly refined and clinically…
- Conditions
- Aortic Valve Disease, Pulmonary Valve Disease, Child, Only, Magnetic Resonance Imaging
- Trial name
- AI-CMR (NCT05979870)
- Testing
- Valvuloplasty,
- Where
- Sweden
- Volunteers
- 45 people
- Sponsor
- Sahlgrenska University Hospital
Anticoagulation, Mechanical Heart Valve Replacement
Choice of Valve Substitute in the Era of Oral Anticoagulation Self-Management
The optimal valve substitute for patients between 60-70 years is controversial. We compared anticoagulation-related adverse events (ARAE) in patients receiving mechanical heart valve replacement (MHVR) on INR self-management vs.
- Trial name
- NCT01269905
- Sponsor
- Johann Wolfgang Goethe University Hospital
Aortic Stenosis
Deep Learning Enhanced Detection of Aortic Stenosis - The DETECT-AS-Diagnostic Study
The DETECT-AS Diagnostic Study will assess the performance of artificial intelligence (AI) risk predictions to detect aortic stenosis using results from portable electrocardiogram (ECG) and cardiac ultrasound devices.
- Trial name
- NCT06749145
- Testing
- Portable 1-lead electrocardiogram, Point-of-care ultrasound, AI-ECG risk algorithm
- Where
- 3 sites in United States
- Volunteers
- 410 people, healthy volunteers welcome
- Sponsor
- Yale University
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
Sleep Disturbances, Postoperative Discomfort
Effect of Virtual Reality and Binaural Beat on Sleep and Comfort in Adults After Mechanical Valve Replacement Surgery
This study will compare the effects of Virtual Reality and Binaural Beat Stimulation on sleep quality and discomfort in adult patients who have undergone prosthetic mechanical valve replacement surgery.
- Conditions
- Sleep Disturbances, Postoperative Discomfort, Heart Valve Diseases
- Trial name
- VR-BBS (NCT07365488)
- Testing
- Virtual Reality Relaxation, Binaural Beat Stimulation, VR + Binaural Beat Group
- Where
- Iraq
- Volunteers
- 140 people
- Sponsor
- University of Baghdad