Clinical trials: Heart Valve Prosthesis Implantation
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
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
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
Severe Symptomatic Aortic Stenosis
Evaluation of Length of Stay After TF-TAVI
Transcatheter aortic valve implantation (TAVI) has been rapidly adopted worldwide since the first-in-man TAVI performed in 2002.
- Trial name
- FAST-TAVI (NCT02956915)
- Testing
- Transfemoral Transcatheter aortic valve implantation
- Where
- 5 sites in France
- Volunteers
- 300 people
- Sponsor
- University Hospital, Rouen
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 Stenosis
Hydra Registry - Italy Experience
Hydra-IT is a multicenter observational study aim to collect clinical, procedural and follow-up data and evaluate the short, medium and long term results of Hydra TAVI System in patient with severe aortic stenosis.
- Trial name
- NCT05956652
- Testing
- Hydra Transcatheter Aortic Valve System
- Where
- 4 sites in Italy
- Sponsor
- Sahajanand Medical Technologies Limited
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
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
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
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
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
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
Aortic Valve Stenosis
TAVI Without Balloon Predilatation (of the Aortic Valve ) SAPIEN 3
Balloon predilatation of the aortic valve has been regarded as an essential step during the transcatheter aortic valve implantation (TAVI) procedure.
- Trial name
- DIRECTAVI (NCT02729519)
- Testing
- TAVI
- Where
- France
- Volunteers
- 250 people
- Sponsor
- University Hospital, Montpellier
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.
Prosthesis Survival, Prosthesis; Cardiac, Heart, Functional Disturbance as Result
Transcatheter Aortic Valve Implantation Versus Standard Surgical Aortic Valve Replacement
The mechanical intervention is treating aortic valve stenosis (AVS) which may be performed using the standard open surgical approach for aortic valve replacement (AVR) or transcatheter aortic valve implantation (TAVI).
- Trial name
- TAVISAR (NCT05261204)
- Testing
- Transcatheter Aortic Valve Implantation, Bioprothesis, Sutureless
- Where
- France
- Volunteers
- 4,000 people
- Sponsor
- Centre Cardiologique du Nord
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