Clinical trials: Implantation, Heart Valve Prosthesis
Heart Valve Diseases, Aortic Valve Stenosis
BIOVALVE - I / II Clincial Investigation
First-in-Human clinical investigation to evaluate the safety and clinical performance of the BIOVALVE prosthesis in subjects presenting with severe symptomatic aortic valve stenosis, which are as judged by the heart team…
- Trial name
- BIOVALVE (NCT02249000)
- Testing
- BIOVALVE prosthesis
- Where
- 13 sites in Belgium, Germany and 2 more
- Volunteers
- 68 people
- Sponsor
- Biotronik AG
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
Aortic Valve Stenosis, Implantation, Heart Valve Prosthesis
Supra-Annular vs. Annular ValvEs for Small Annuli
Open-label, prospective randomized comparison of Supra-annular valves (Medtronic Evolut Pro) vs. annular valves (Edwards Sapien Ultra) for small annuli (≤23 mm)
- Trial name
- SAVE (NCT04372381)
- Testing
- Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro
- Where
- 3 sites in United States
- Sponsor
- University of Arizona
Bicuspid Aortic Valve, Aortic Valve Stenosis
Progression of Ascending Aorta Diameters in Bicuspid Aortic Valve After Transcatheter or Surgical Replacement.
The goal of this prospective, non-randomized, single-center, observational study is to assess whether there is a progressive dilation of ascending aorta after surgical or transcatheter aortic valve replacement (TAVR) in patients…
- Conditions
- Bicuspid Aortic Valve, Aortic Valve Stenosis, Aortic Aneurysm, Heart Diseases
- Trial name
- ARDITAV (NCT05708118)
- Testing
- Echocardiographic assessment., Computed-tomography assessment
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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
Bioprosthetic Valve Failure, Prosthetic Heart Valve Dysfunction
REVIVE-FR Registry
This registry aims to investigate treatment options for patients whose previously implanted biological aortic heart valve no longer functions properly.
- Conditions
- Bioprosthetic Valve Failure, Prosthetic Heart Valve Dysfunction, Structural Valve Deterioration, Prosthetic Heart Valve Thrombosis
- Trial name
- NCT07885761
- Testing
- TAVI-in-SAVR (Valve-in-Valve), THV-in-THV (Redo-TAVI), Surgical Explantation of a Failed Transcatheter Heart Valve
- Volunteers
- 200 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
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
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.
Eisenmenger Syndrome
Transcatheter Valve Implantation in Patients With Dysfunctional Left and Right Sided Heart Valves
A growing body of data, suggests that transcatheter valves are effective when implanted in other locations (mitral, aortic, tricuspid) and in high pressure environments.
- Trial name
- NCT02119442
- Testing
- Transcather Valve Implantation
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- University of California, Los Angeles
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
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, 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
Cardiac Surgery, Peri Operative Medicine
Risk Factors of Atrial Fibrillation After Cardiac Surgery
Supraventricular arrhythmias complicate more than 40% of cardiac surgeries and are associated with an increased risk of bleeding, stroke, heart failure, and death.
- Conditions
- Cardiac Surgery, Peri Operative Medicine, Thoracic Surgery, Cardiopulmonary Bypass
- Trial name
- PFAS (NCT07625033)
- Where
- France
- Volunteers
- 918 people
- Sponsor
- Centre Hospitalier Régional Metz-Thionville
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
Valve Heart Disease, Coronary Artery Disease
Post-Operative Myocardial Incident & Atrial Fibrillation
To explore predictors of major cardio-vascular events after cardiac surgery and trans-catheter valve implantation with a specific interest in studying mechanisms linking pre-operative leukocyte, fat and myocardial phenotypes with…
- Trial name
- POMI-AF (NCT03376165)
- Where
- France
- Volunteers
- 1,500 people
- Sponsor
- University Hospital, Lille
Aortic Valve Stenosis, Aortic Valve Calcification
Safety and Performance of TAVI of Venus MedTech Aortic Valve Prosthesis
1. objectives Evaluate the performance of Venus MedTech aortic valve prosthesis intervention by femoral artery Evaluate safety and clinical benefit of percutaneous implantation of the Venue MedTech aortic valve prosthesis.
- Trial name
- Venus-A (NCT01683474)
- Testing
- Venus MedTech Aortic Valve Prosthesis
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Venus MedTech (HangZhou) Inc.
Aortic Valve Insufficiency
Results of the Aortic Valve Reconstruction in Children
Aortic valve disease counts up to 5% of cases of congenital heart disease being one of the most common congenital malformations of the cardiovascular system.
- Trial name
- NCT04162444
- Testing
- Physical examination, The Ross Classification for Heart Failure in Children, The Aristotle score
- Where
- Russia
- Volunteers
- 40 people
- Sponsor
- National Medical Research Center for Children's Health, Russian Federation
Atrial Fibrillation, Thrombus Due to Heart Valve Prosthesis
Validation of International Warfarin Pharmacogenetics Consortium (IWPC) Algorithm in Elderly Patients With Comorbidity
The purpose of this study is to validate the International Warfarin Pharmacogenetics Consortium (IWPC) algorithm in a prospective cohort of elderly people (65 years or older) with heart valves and/or nonvalvular atrial…
- Trial name
- VIALE (NCT02069132)
- Testing
- Warfarin
- Where
- 3 sites in Italy
- Volunteers
- 376 people
- Sponsor
- University of Campania Luigi Vanvitelli