Clinical trials: Prosthetic Heart Valve
Aortic Valve Disease
Transapical Implantation of Ventor Embracer™ Valve in Patients With Severe Aortic Valve Disease
A prospective single arm study evaluating feasibility and safety of a catheter-based transapical implantation of the Ventor Embracer™ aortic valve bioprosthesis in patients with severe aortic valve disease, specifically aortic…
- Trial name
- NCT00677638
- Testing
- Ventor Embracer
- Where
- 3 sites in Germany
- Volunteers
- 30 people
- Sponsor
- Ventor Technologies
Endocarditis, Bacterial, Endocarditis
Effectiveness of Antibiotic Prophylaxis of Infective Endocarditis for Invasive Dental Procedures in Patients With Prosthetic Heart Valves and/or History of Infective Endocarditis
Infective endocarditis (IE) continues to cause serious morbidity and mortality. To reduce its incidence, antibiotic prophylaxis has been recommended before invasive dental procedures in patients with at risk predispositions.
- Conditions
- Endocarditis, Bacterial, Endocarditis, Endocarditis Acute and Subacute
- Trial name
- PROPHETS (NCT05613933)
- Testing
- Improved practices
- Volunteers
- 250,000 people
- Sponsor
- University Hospital, Bordeaux
Atrial Fibrillation, Deep Vein Thrombosis
Applying Pharmacogenetics to Warfarin Dosing in Chinese Patients
The purpose of this study is to determine whether pharmacogenetic guided dosing of warfarin is promising for the improvement of efficiency, therapeutic efficacy, and, especially, safety of warfarin therapy than a dosing regimen…
- Conditions
- Atrial Fibrillation, Deep Vein Thrombosis, Pulmonary Embolism, Heart Valve Disease
- Trial name
- NCT01610141
- Testing
- Genotype-guided warfarin dosing, Non-genotype guided warfarin dosing
- Where
- China
- Volunteers
- 500 people
- Sponsor
- Chinese PLA General Hospital
Mechanical Prosthetic Heart Valve Implantation, Patient Self Monitoring of Oral Anticoagulent Therapy
Benefit of Self-monitoring of Anticoagulation Instrument
To evaluate the benefit economic and medical of self-monitoring of coagulation compared with conventional follow-up of anticoagulation in a population recently fitted with mechanical heart valves.
- Trial name
- 4A (NCT00506870)
- Testing
- INRatio / Coaguchek XS
- Where
- France
- Volunteers
- 919 people
- Sponsor
- University Hospital, Bordeaux
Kidney Failure, Chronic, Coronary Artery Disease
Prophylactic Effect of Nifedipine on Further Decline in Renal Function in Patients Undergoing Open-Heart Surgery
To compare renal function (51Cr-EDTA clearance) 48 hours post open-heart surgery (coronary bypass or valve surgery) in patients with impaired renal function after randomization to either nifedipine infusion at start of surgery…
- Trial name
- NCT00244530
- Testing
- Nifedipine
- Where
- Norway
- Volunteers
- 20 people
- Sponsor
- University of Oslo School of Pharmacy
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.
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
Structural Valve Deterioration, Structural Valve Degeneration
The ReTAVI Prospective Observational Registry
Patients with severe aortic stenosis (sAS) treated with transcatheter aortic valve implantation (TAVI) (increasingly younger \& lower risk pts) are experiencing SVD of the index THV and thus developing an indication for a…
- Conditions
- Structural Valve Deterioration, Structural Valve Degeneration, Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure, Prosthetic Valve Malfunction
- Trial name
- NCT05601453
- Testing
- Elective redo transcatheter aortic valve implantation (redo-TAVI)
- Where
- 62 sites in Austria, Canada and 9 more
- Volunteers
- 250 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Poor Drug Response
The Prevalence of Sub Optimal Anti Coagulation
A study on warfarin administration to show whether noncompliance of the patient will affect our target (INR) during therapy or not beside its drug and dietary interactions.
- Trial name
- NCT03485300
- Testing
- Liver and kidney function tests for patients with chronic liver or kidney diseases, Non compliance of the patient, Drug or food interactions
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Assiut University
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
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.
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.
Atrial Fibrillation, Venous Thromboembolism
Self-management of Anticoagulation Treatment
The aim of the study was to compare self-management of anticoagulant treatment with conventional anticoagulant treatment in Norway.
- Conditions
- Atrial Fibrillation, Venous Thromboembolism, Artificial Heart Valve
- Trial name
- NCT02864537
- Testing
- Training
- Volunteers
- 130 people
- Sponsor
- University of Bergen
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
Valvular Heart Disease
Evaluation and Validation of Management Strategy for Conductive Disorders After TAVR (EVATAVI)
Considering decrease of major complications and improvement of procedural results, conductive disorders currently remain the main issue after TAVR (Transcatheter aortic valve replacement).
- Trial name
- EVATAVI (NCT05417464)
- Testing
- Use of flowchart
- Where
- France
- Volunteers
- 250 people
- Sponsor
- University Hospital, Montpellier
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.
Infective Endocarditis
Rifampin-free Regimen Versus Rifampin-containing Regimen in the Treatment of Staphylococcal Prosthetic Valve Endocarditis
The primary objective of this study is to demonstrate that a rifampin-free regimen is non-inferior to the rifampin-containing regimen in terms of all-cause mortality in staphylococcal prosthetic valve endocarditis within 6 months…
- Trial name
- RIFREE (NCT07345325)
- Testing
- Rifampin-free regimen, Rifampin containing regimen
- Where
- 31 sites in France
- Volunteers
- 422 people
- Sponsor
- Nantes University Hospital
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
Anticoagulant Antagonists, Vitamin K and Other Coagulants Causing Adverse Effects in Therapeutic Use, Atrial Fibrillation
Evaluation of Oral Anticoagulation With Vitamin K Antagonists - The thrombEVAL Study Programme
Since decades, oral anticoagulation (OAC) with vitamin K antagonists (VKA) is an established therapy for both prevention and treatment of thromboembolism in daily clinical routine.
- Conditions
- Anticoagulant Antagonists, Vitamin K and Other Coagulants Causing Adverse Effects in Therapeutic Use, Atrial Fibrillation, Venous Thromboembolism
- Trial name
- thrombEVAL (NCT01809015)
- Where
- Germany
- Volunteers
- 2,318 people
- Sponsor
- Johannes Gutenberg University Mainz
Valvular Endocarditis
Surgical Management of Valvular Endocarditis
This study aims to achieve the following objectives objective 1 : To review the Investigators' experience of surgical management of infective endocarditis (IE) and analyze the outcomes and associated prognostic factors objective…
- Trial name
- NCT04572529
- Testing
- Cardiac Valve replacement
- Volunteers
- 50 people
- Sponsor
- Assiut University