Clinical trials: Prosthetic Heart Valve
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
Thrombotic and Bleeding Events
On-X Aortic Prosthetic Heart Valve Low Dose Warfarin Post Approval Clinical Registry Study
The purpose of the proposed study is to assess the occurrence of bleeding, valve-related thromboembolism and valve thrombosis with the On-X Aortic Prosthetic Heart Valve when targeted at an International Normalized Ratio (INR)…
- Trial name
- NCT02677974
- Testing
- On-X Aortic Heart Valve replacement
- Where
- 23 sites in United States, Canada and 1 more
- Volunteers
- 510 people
- Sponsor
- On-X Life Technologies, Inc.
Cardiac Anaesthesia
Registry of Cardio/Neurovascular Anesthesia Including the Database of Biological Signals During Anesthesia, Preoperative Assessment and Prognosis in Patients
The purpose of this study is to establish a registry database for patients undergoing anesthesia for cardiovascular surgery or procedures in our operating or hybrid room. The following information will be collected: 1.
- Trial name
- NCT04833751
- Where
- South Korea
- Volunteers
- 10,000 people
- Sponsor
- Yonsei University
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
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
Mechanical Heart Valve Prosthesis
Noise Associated With a Mechanical Heart Valve Prosthesis: Does the Memory of Preoperative Information Have an Influence on Postoperative Quality of Life?
As part of the follow-up in the Day Hospital in the national reference center for Marfan syndrome and related disorders, each consultant benefits from a psychological interview.
- Trial name
- QUALICLIC (NCT07304115)
- Where
- France
- Volunteers
- 180 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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
Critical Aortic Stenosis
The Nordic Aortic Valve Intervention Trial
A randomized clinical trial of transcatheter aortic valve implantation (TAVI) versus conventional surgical aortic valve replacement (SAVR) in patients older than 70 years of age suffering from severe aortic valve stenosis.
- Trial name
- NOTION (NCT01057173)
- Testing
- Transcatheter Aortic Valve Implantation, Surgical Aortic Valve Replacement
- Where
- 3 sites in Denmark, Sweden
- Volunteers
- 280 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Mitral Valve Disease, Damaged Mitral Valve
HALO: A Single Arm Prospective Investigation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve
The purpose of the study is to provide evidence of safety and effectiveness of the study valve. The rationale is to offer a replacement mitral valve for patients with anatomy that is too small for the currently commercially…
- Conditions
- Mitral Valve Disease, Damaged Mitral Valve, Malfunctioning Mitral Heart Valve, Mitral Valve Replacement
- Trial name
- NCT02097420
- Testing
- Mitral valve replacement SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve
- Where
- 24 sites in United States
- Volunteers
- 23 people
- Sponsor
- Abbott Medical Devices
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
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
Heart Valve Prosthesis, Aortic Stenosis
Comparison of Sutureless Vs. Standard Biological Prostheses for Surgical Aortic Valve Replacement
Multicenter randomised study which aims to compare sutureless Vs. standard bio- prostheses (1:1) among patients undergoing surgical aortic valve replacement in terms of: 6 -month hemodynamic performance.
- Conditions
- Heart Valve Prosthesis, Aortic Stenosis, Hemodynamics
- Trial name
- COPERA (NCT03965065)
- Testing
- Sutureless aortic bioprosthesis, Conventional stented sutured aortic prosthesis
- Where
- Spain
- Volunteers
- 350 people
- Sponsor
- Hospital San Carlos, Madrid
Atrial Fibrillation, Deep Vein Thrombosis
Genotype-Guided Warfarin Therapy Trial
The purpose of the investigators' study is to determine the clinical utility of a warfarin-dosing algorithm that incorporates genetic information (VKORC1 and CYP2C9 alleles) for adult patients initiating warfarin therapy.
- Conditions
- Atrial Fibrillation, Deep Vein Thrombosis, Pulmonary Embolism, Artificial Heart Valve
- Trial name
- WARFPGX (NCT00904293)
- Testing
- Genotype-guided dose determination, Non-genotype guided warfarin dosing
- Where
- United States
- Volunteers
- 109 people
- Sponsor
- University of North Carolina, Chapel Hill
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
Cardiac Surgical Procedures, Heart Valve Prosthesis Implantation
Myocardial Protection With Phosphocreatine in High-RIsk Cardiac SurgEry Patients
There is evidence on the role of the phosphotransfer system in the energy metabolism of the heart, with altered energetics playing an important role in the mechanisms of heart failure.
- Trial name
- PRISE (NCT02757443)
- Testing
- Phosphocreatine sodium tetrahydrate after anaesthesia induction, 5% Glucose after anaesthesia induction, Phosphocreatine sodium tetrahydrate added to cardioplegia
- Where
- Russia
- Volunteers
- 120 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Thrombolysed
To Compare the Efficacy & Safety of Ultra-Slow (24 hr) Low Dose (25 mg) Infusion of Alteplase Over Slow (24hr) Infusion of Streptokinase in Mechanical Prosthetic Valve Thrombosis
Annual incidence of PVT for mechanical valves is 0.3 - 1.3% patient-yrs. First postoperative year is marked by a 24% incidence of thrombosis.
- Trial name
- PHVT (NCT07360717)
- Testing
- Alteplase, streptokinase
- Where
- India
- Volunteers
- 100 people
- Sponsor
- U. N. Mehta Institute of Cardiology and Research Center
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
Pregnancy, Anticoagulation
Evaluation of Maternal and Fetal Outcomes in Pregnancies in Women With Prosthetic Heart Valves
The ability to diagnose and surgically repair poorly functioning heart valves has yielded a significant population of women that are of childbearing age with mechanical/ bioprosthetic heart valves.
- Conditions
- Pregnancy, Anticoagulation, Prosthetic Heart Valves
- Trial name
- NCT00329290
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of California, Irvine
Prosthetic Valve Thrombosis
A Study Comparing a New Dosing Regimen of Clot-dissolving Drug for Mechanical Heart Valves Which Show Clots
The optimal dosage and duration of administration of clot-dissolving medications for the treatment of patients with mechanical heart valves with clots is not known.
- Trial name
- RAFT-PVT (NCT00232622)
- Testing
- Streptokinase
- Volunteers
- 120 people
- Sponsor
- All India Institute of Medical Sciences
Aortic Valve Stenosis, Valsartan
Efficacy of Angiotensin Receptor Blocker Following aortIc Valve Intervention for Aortic STenOsis: a Randomized mulTi-cEntric Double-blind Phase II Study
Aortic stenosis (AS) is the most frequent valvular heart disease in Western countries, with increasing prevalence. Recent guidelines recommend aortic valve intervention (surgical aortic valve replacement [SAVR] or transcatheter…
- Conditions
- Aortic Valve Stenosis, Valsartan, Angiotensin Receptor Antagonists, Transcatheter Aortic Valve Replacement
- Trial name
- ARISTOTE (NCT03315832)
- Testing
- Valsartan
- Where
- France
- Sponsor
- University Hospital, Limoges