Clinical trials: Disorder of Prosthetic Cardiac Valve
Aortic Valve Disease, Heart Valve Prosthesis Implantation
Comparison of Antithrombotic Treatments After Aortic Valve Replacement. Rivaroxaban: A New Antithrombotic Treatment for Patients With Mechanical Prosthetic Aortic Heart Valve.
Objectives Primary objective: To determine if rivaroxaban (Xarelto) is feasible and safe for prevention of major complications in patients undergoing a mechanical aortic heart valve replace-ment.
- Conditions
- Aortic Valve Disease, Heart Valve Prosthesis Implantation, Anticoagulants
- Trial name
- CATHAR (NCT02128841)
- Testing
- Rivaroxaban
- Where
- Switzerland
- Volunteers
- 12 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Valvular Heart Disease
Observational Study of Prosthetic Tissue Aortic and Mitral Heart Valve
This study is a multi-center, prospective, non-randomized, observational study. The objectives of this study are to confirm the clinical safety and efficacy of the SJM Epic valve.
- Trial name
- EPIC (NCT00329667)
- Testing
- EPIC
- Volunteers
- 761 people
- Sponsor
- Abbott Medical Devices
Anti-coagulation Therapy, DVT
Warfarin Adverse Event Reduction For Adults Receiving Genetic Testing at Therapy INitiation (WARFARIN)
The WARFARIN Study is a clinical trial designed to determine if the use of genetic information related to warfarin sensitivity can help create a dose of warfarin that will result in less hospitalizations and deaths related to…
- Conditions
- Anti-coagulation Therapy, DVT, Pulmonary Embolism, Joint Surgery Multiple
- Trial name
- WARFARIN (NCT01305148)
- Testing
- Warfarin GenoSTAT Test
- Where
- 56 sites in United States
- Volunteers
- 3,800 people
- Sponsor
- Iverson Genetic Diagnostics, Inc.
Stroke
PERIOP 2 - A Safety and Effectiveness of LMWH vs Placebo Bridging Therapy for Patients on Long Term Warfarin Requiring Temporary Interruption of Warfarin.
The purpose of the study is to determine the effectiveness and safety of LMWH postoperative bridging therapy (standard of care) versus postoperative placebo bridging therapy (experimental arm)for patients with mechanical heart…
- Trial name
- NCT00432796
- Testing
- Dalteparin
- Where
- 8 sites in Canada, India
- Volunteers
- 1,473 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Pregnancy, Heart; Complications, Valve, Prosthesis
Anticoagulation Regimens in Pregnant Patients With Prosthetic Heart Valves
Pregnancy is associated with increased risk of thrombosis among women with mechanical prosthetic heart valves.However, the best anticoagulant treatment strategies for pregnant patients with prosthetic heart valves have been…
- Trial name
- NCT02240927
- Testing
- Low Molecular Weight Heparine : Enoxaparine, Enoxaparine and 2.5 mg Warfarin, Enoxaparine and 4mg Warfarin
- Where
- Turkey (Türkiye)
- Volunteers
- 40 people
- Sponsor
- Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
Mycobacterium Chimaera Infections
Prosthetic Valve and Graft Endocarditis With Mycobacterium Chimaera
Mycobacterium chimaera infections have occurred in post-cardiac surgery patients in association with contaminated cardiac bypass heater-cooler devices. So far optimal therapeutical concepts are not clear.
- Trial name
- NCT04429256
- Testing
- data collection
- Where
- Switzerland
- Volunteers
- 7 people
- Sponsor
- University Hospital, Basel, Switzerland
Aortic Valve Disease, Aortic Valve Stenosis
Evaluating the Safety and Efficacy of Prosthetic Polymer Heart Valves for the Treatment of Aortic Valve Disease
The purpose of this study is to conduct the initial 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 Disease, Aortic Valve Stenosis, Aortic Valve Regurgitation
- Trial name
- NCT06518681
- Testing
- PoliaValve (Aortic)
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Suzhou Hearthill Medical Technology Co.,LTD
Aortic Valve Disease
4D- Flow- MRI After Aortic Valve Surgery
This randomized controlled trial was designed to analyze flow patterns in the ascending aorta with MRI after either Trileaflet reconstruction of the aortic valve with autologous pericardium (TriRec) or surgical valve replacement…
- Trial name
- NCT04223713
- Testing
- TriRec, Aortic valve replacement
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Sacubitril/Valsartan, Prosthetic Heart Valve
Sacubitril/Valsartan in Patients With Prosthetic Heart Valves With Heart Failure and Reduced Ejection Fraction
This study aims to evaluate the effect of sacubitril/valsartan in patients with prosthetic heart valves with heart failure with reduced ejection fraction (HFrEF).
- Conditions
- Sacubitril/Valsartan, Prosthetic Heart Valve, Heart Failure, Reduced Ejection Fraction
- Trial name
- NCT07192341
- Testing
- Sacubitril/Valsartan, Conventional anti-heart failure therapy
- Where
- Egypt
- Volunteers
- 220 people
- Sponsor
- Kafrelsheikh University
Mitral Valve Stenosis and Insufficiency, Atrial Fibrillation
Dabigatran in Patients With Atrial Fibrillation and Mitral Biological Prostheses
The efficacy and safety of anticoagulation therapy using dabigatran in comparison with warfarin will be evaluated in patients with atrial fibrillation after mitral valve prosthetic replacement concomitant with Cox-Maze procedure.
- Trial name
- NCT03183843
- Testing
- Dabigatran Etexilate, Warfarin
- Where
- Russia
- Volunteers
- 40 people
- Sponsor
- Research Institute for Complex Problems of Cardiovascular Diseases, Russia
Thrombosis
Anticoagulation Regiments in Patients With Prosthetic Heart Valve Thrombosis
Prosthetic valve thrombosis is a serious complication with high mortality and morbidity. However, the best anticoagulant treatment strategies for patients with prosthetic heart valve thrombosis have not been fully known.
- Trial name
- NCT02240953
- Testing
- Warfarin, Warfarin + ASA 100 mg + PPI, Warfarin + ASA 300 mg + PPI
- Where
- Turkey (Türkiye)
- Volunteers
- 180 people
- Sponsor
- Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
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 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.
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
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
Endocarditis
The Value of 99mTc-Leukoscan® Scintigraphy in the Diagnosis of Infectious Endocarditis on Surgical Materials
Infectious endocarditis is a serious pathology with difficult diagnosis especially on prosthetic valves or cardiac device because of the plurality of clinical presentations and the low sensitivity value of echocardiography in…
- Trial name
- PLEIM (NCT03112356)
- Testing
- 99mTc-Leukoscan® scintigraphy
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Hospices Civils de Lyon
Infective Endocarditis
Contribution of PET/CT With Gallium 68 Citrate (68Ga-PET/CT) for the Diagnosis of Prosthetic Valve Infective Endocarditis
CiGal-EI-TEP is an exploratory study that aim to assess the diagnostic performance of 68Ga Positron emission tomography (PET) / Computed Tomography (CT) for the diagnosis of prosthetic valve infective endocarditis in comparison…
- Trial name
- CiGal-EI-TEP (NCT05446376)
- Testing
- 68Ga-citrate PET/CT
- Where
- France
- Volunteers
- 19 people
- Sponsor
- University Hospital, Bordeaux
Prosthetic Valve Endocarditis
Evolution of PET Fixation With FDG at the End of Antibiotic Treatment of Infective Endocarditis on Valvular Prosthesis
In patients with prosthetic valve endocarditis (PVE) and pathological valvular FDG uptake on the initial FDG-PET and not referred to valve replacement at the acute phase, the study will assess whether FDG-PET is able to identify…
- Trial name
- EndEOTEP (NCT05989152)
- Testing
- FDG-PET at the end of treatment for IE
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Heart Valve Diseases
The Study of Biological Prosthetic Heart Valves With the "Easy Change" System
The study of new biological heart valves with the "easy change" system, including an assessment of the basic hemodynamic characteristics of the prosthesis, complications associated with valve implantation, and general mortality
- Trial name
- NCT04442100
- Testing
- valve prosthetics
- Where
- Russia
- Volunteers
- 500 people
- Sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
Aortic Valve Disease, Aortic Valve Stenosis
Evaluation of the Inflammatory Response in Post-operated Aortic Valve Replacement Patients.
Background Calcification of the aortic valve affects more than 26% of adult patients over 65 years of age and is the main indication for valve replacement in the United States of America.
- Conditions
- Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Calcification, Prosthetic Valve Malfunction
- Trial name
- NCT04557345
- Testing
- Determination of cytokines, Two-dimensional transthoracic echocardiogram
- Where
- Mexico
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Instituto Nacional de Cardiologia Ignacio Chavez