Clinical trials: Heart Valve Prosthesis
Survival, Prosthesis, Prosthesis Durability
SPAnish Aortic VALVE Multicentric Study
Currently there is an increase in the use of bioprosthesis worldwide (> 70% according to national data of the Spanish Society of Thoracic and Cardiovascular Surgery).
- Conditions
- Survival, Prosthesis, Prosthesis Durability, Valve Heart Disease
- Trial name
- SPAVALVE (NCT03595423)
- Testing
- Surgical AVR with bioprosthetic or mechanical prosthesis
- Where
- Spain
- Volunteers
- 5,000 people
- Sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Valve Heart Disease, Anticoagulants; Increased
Randomized Evaluation of D-dimer Guiding dUration of Oral antiCoagulation thErapy
Guidelines recommended that patients with bioprosthetic heart valves (BHV) only need 6 months oral anticoagulation therapy after operation.
- Trial name
- REDUCE (NCT03885180)
- Testing
- Warfarin Sodium
- Where
- China
- Volunteers
- 500 people
- Sponsor
- Wuhan Asia Heart Hospital
Aortic Valve Stenosis
Hemodynamic Comparison of Tissue Aortic Valves
The purpose of this study is to: 1. Assess for hemodynamic differences at rest and with exercise between three clinically available tissue aortic valves. 2.
- Trial name
- NCT01635244
- Testing
- Aortic valve replacement
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of Michigan
Left Main Coronary Artery Disease, Left Anterior Descending Coronary Artery Stenosis
Prospective Evaluation for Hybrid Cardiac Procedures
Multidisciplinary team-approach in order to offer personalized treatments represents the emerging mainstream in cardiovascular medicine.
- Conditions
- Left Main Coronary Artery Disease, Left Anterior Descending Coronary Artery Stenosis, Valve Disease, Heart, Carotid Stenosis
- Trial name
- PERHAPS (NCT05143671)
- Testing
- Coronary artery bypass grafting, Percutaneous coronary intervention, Surgical valve replacement
- Where
- Italy
- Volunteers
- 134 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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
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
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
Aortic Stenosis, Coronary Artery Disease
Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent (RE-ACCESS)
With the upcoming expansion of transcatheter aortic valve replacement (TAVR) indications to younger patients, the feasibility of coronary ostia cannulation beyond different bioprosthesis stent is currently a matter of debate.
- Trial name
- RE-ACCESS (NCT04026204)
- Where
- Italy
- Volunteers
- 300 people
- Sponsor
- University of Catania
Aortic Valve Stenosis, Aortic Valve Regurgitation
Valve Hemodynamic Optimization Based on Doppler-Echocardiography vs Catheterization Measurements Following ViV TAVR
Data on valve performance following ViV-TAVR has usually been obtained with the use of Doppler-echocardiography. However, some reports have shown significant discordances in the evaluation of mean transvalvular gradient between…
- Conditions
- Aortic Valve Stenosis, Aortic Valve Regurgitation, Prosthesis Failure
- Trial name
- ECHOCATH (NCT05459233)
- Testing
- Doppler-echocardiography, Invasive hemodynamic measurements
- Where
- 7 sites in United States, Canada
- Volunteers
- 310 people
- Sponsor
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Coronary Disease, Heart Valve Diseases
CTI-01 (Ethyl Pyruvate) Safety and Complication Prevention in Cardiac Surgery Patients on Cardiopulmonary Bypass (CPB)
Over 500,000 patients undergo cardiac surgery with CPB in the United States annually. Although mortality rates have decreased with advances in perioperative care, many patients are affected by postoperative organ dysfunction.
- Trial name
- NCT00107666
- Testing
- CTI-01 (ethyl pyruvate)
- Where
- 17 sites in United States
- Volunteers
- 150 people
- Sponsor
- Critical Therapeutics
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
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
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
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
Valvulopathy
Stent Implantation of Polyurethane Expandable Valve, by Catheter, in Patients With Pulmonary Valve Dysfunction
Prospective Study, Single Arm to evaluate the safety and efficacy of polyurethane expandable valve implantation in the pulmonary position, in 5 patients over 18 years of age, with pulmonary valve dysfunction and moderate to…
- Trial name
- NCT05289622
- Testing
- Polyurethane expandable valve stent implant
- Where
- Brazil
- Volunteers
- 5 people
- Sponsor
- Dr. Miguel Angel Maluf
Aortic Valve Disease
REpositionable Versus BallOOn-expandable Prosthesis for Trans-catheter Aortic Valve Implantation
There are different aortic valve prosthesis used for treatment of aortic valve disease through catheter-based procedures. The current study aims to compare two different aortic valve prosthesis regarding their outcomes at 30-day…
- Trial name
- REBOOT (NCT02668484)
- Testing
- repositionable valve prosthesis, balloon-expandable valve prosthesis
- Where
- 3 sites in Germany, Italy
- Volunteers
- 116 people
- Sponsor
- LMU Klinikum
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
Coronary Artery Disease, Mitral Valve Regurgitation
Effect of Etomidate on Hemodynamics and Adrenocortical Function After Cardiac Surgery
The purpose of this study is to evaluate the effect of a single dose of etomidate for patients undergoing cardiac surgery with the use of cardiopulmonary bypass (CPB) on post-CPB adrenocortical responsiveness, on requirements of…
- Trial name
- NCT00415701
- Testing
- Etomidate, Propofol, Hydrocortisone
- Where
- Switzerland
- Volunteers
- 130 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
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
Prosthesis; Cardiac, Heart, Functional Disturbance as Result
Rivaroxaban in Mechanical Valves: RMV Study
Anticoagulant treatment reduces the incidence of death and cardioembolic events in patients with atrial fibrillation or prosthetic heart valve and the incidence of death and recurrences in patients with VTE.
- Trial name
- RMV (NCT02894307)
- Testing
- Rivaroxaban
- Sponsor
- Hospital Ana Nery