Clinical trials: Heart Valve Replacement
Cardiac Rehabilitation
Home-based Mobile Guided Exercise-based Cardiac Rehabilitation Among Patients Undergoing TAVR
A two-parallel, evaluator-blind, single-center, randomized controlled trial was designed to assess the effectiveness of a home-based mobile guided exercise-based cardiac rehabilitation among patients undergoing Transcatheter…
- Trial name
- REHAB-TAVR (NCT05989594)
- Testing
- Home-based mobile guided exercise-based cardiac rehabilitation, Routine Care
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Shanghai Zhongshan Hospital
Aortic Valve Insufficiency, Regurgitation, Aortic Valve
Aortic Valve Replacement With Trifecta(TM)
The purpose of this study is to confirm the clinical safety and effectiveness of the Trifecta valve.
- Conditions
- Aortic Valve Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence, Aortic Valve Stenosis
- Trial name
- NCT00475267
- Testing
- Trifecta aortic heart valve
- Where
- 5 sites in Canada
- Volunteers
- 203 people
- Sponsor
- Abbott Medical Devices
Aortic Stenosis
Association of Type of Anesthetic and Outcomes in Transfemoral Aortic Valve Replacement
This study proposes to perform a descriptive analysis and pilot observational study looking at the types and quantity of anesthetic agents used and their associations with outcomes among patients scheduled to receive transfemoral…
- Trial name
- NCT02786264
- Testing
- Dexmedetomidine with propofol, Propofol
- Volunteers
- 186 people
- Sponsor
- Yale University
Transcatheter Aortic Valve Replacement (TAVR), Aortic-Stenosis
Prospective, Long-term Evaluation of the SAPIEN 3 Ultra RESILIA Valve
Evaluation of clinical outcomes and valve performance of the SAPIEN 3 Ultra Resilia (S3UR) valve over 10 years.
- Conditions
- Transcatheter Aortic Valve Replacement (TAVR), Aortic-Stenosis, Aortic Insufficiency, Degenerative Valve Disease
- Trial name
- RESOUND-EU (NCT06953206)
- Testing
- Transcatheter aortic valve (S3UR) replacement (TAVR)
- Where
- Germany
- Volunteers
- 500 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Aortic Valve Stenosis, Ventricular Dysfunction, Left
Ventriculo-arterial Coupling Modification Evaluated by PRAM During TAVI Procedure
Calcified aortic stenosis is the most frequent valvulopathy in Europe and North America. Aortic stenosis is an obstacle to the ejection of blood from the left ventricle to the aorta and leads to morphological changes in the left…
- Trial name
- PRAM-TAVI (NCT03385785)
- Where
- France
- Volunteers
- 20 people
- Sponsor
- Central Hospital, Nancy, France
Aortic Valve Stenosis, Aortic Valve Disease
Anticoagulation for Aortic Bioprosthesis (ANTIPRO)
This study evaluates the clinical and hemodynamic outcome in patients after aortic valve replacement. Half of the patients will receive warfarin + aspirin and the other half will receive only aspirin.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Disease, Aortic Valve Insufficiency, Aortic Valve Regurgitation
- Trial name
- NCT03807921
- Testing
- Warfarin, Aspirin
- Where
- 2 sites in Uruguay
- Volunteers
- 140 people
- Sponsor
- Instituto Nacional de Cirugia Cardiaca, Uruguay
Mitral Regurgitation
Sutra Hemi-valve First-in-Human Study
Study to evaluate the feasibility, safety and performance of the Sutra Hemi-valve Transcatheter Mitral Valve Replacement System in patients with moderate-severe and severe symptomatic mitral regurgitation who are at high risk for…
- Trial name
- NCT06552689
- Testing
- Sutra Hemi-valve Transcatheter Mitral Valve Replacement (TMVR) System
- Where
- New Zealand
- Volunteers
- 15 people
- Sponsor
- Sutra Medical, Inc.
Right Ventricular Dysfunction, Rheumatic Heart Disease
Right Ventricular Echo Assessment in Mitral Valve Replacement
Rheumatic heart disease remains a major health problem in developing countries. It is the most important sequel of rheumatic fever and occurs in about 30% of patients with rheumatic fever.Rheumatic heart disease presents with…
- Trial name
- NCT03549052
- Volunteers
- 120 people
- Sponsor
- Assiut University
Bicuspid Aortic Valve
Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry
The objective of this study is to evaluate the procedural and clinical outcomes of patients with bicuspid aortic valve stenosis undergoing transcatheter aortic valve replacement.
- Trial name
- NCT03836521
- Testing
- Transcatheter aortic valve replacement
- Where
- United States
- Volunteers
- 2,000 people
- Sponsor
- Cedars-Sinai Medical Center
Aortic Valve Stenosis
MRI in Transcatheter Aortic Valve Replacement Patients
The hypothesis is that SEV result in superior valvular hemodynamics (more pronounced during exercise) and exercise capacity relative to BEV.
- Trial name
- MRI-TAVR (NCT05603026)
- Testing
- Self-expanding valve (Medtronic Evolut FX), Balloon-expanding valve (Edwards Sapien 3 Ultra RESILIA)
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- University Hospitals Cleveland Medical Center
Use of Dexmedetomidine in Cardiac Surgery (CABG, Valve Replacement or Total Aortic Arch Replacement)
Effect of Dexmedetomidine on Hemodynamics in Cardiac Surgery
It is important to establish a stable haemodynamics in patients undergoing cardiac surgery. Haemodynamic depression is common during induction of anaesthesia [1].
- Trial name
- NCT06958913
- Testing
- Propofol group, Dexmedetomidine
- Where
- Turkey (Türkiye)
- Volunteers
- 52 people
- Sponsor
- Pamukkale University
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.
Endothelial Dysfunction, Aortic Valve Disease
Evaluation of Endothelial Dysfunction During Aortic Valvular Replacement by Bioprosthesis With and Without Extracorporeal Circulation
Patients with aortic stenosis present many risk factors for endothelial dysfunction (arterial hypertension, arteriosclerosis, dyslipidemia, chronic renal insufficiency, etc.).
- Trial name
- DYVA2 (NCT03135496)
- Testing
- Study of endothelial function biological markers
- Where
- France
- Volunteers
- 51 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Inflammation
Efficacy and Safety of Bovine Intestinal Alkaline Phosphatase (bIAP) During Heart Surgery
This multi-centre prospective, randomised, double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of bovine intestinal alkaline phosphatase (bIAP) in reducing the pro-inflammatory post-surgical…
- Trial name
- APPIRED-II (NCT01144611)
- Testing
- bIAP bolus and 8h infusion
- Where
- Netherlands
- Volunteers
- 53 people
- Sponsor
- Alloksys Life Sciences B.V.
Aortic Stenosis
Impact of Beta-blocker on Outcome Among Patients Undergoing Transcatheter Aortic Valve Replacement (B-TAVR)
This is a multi-centric, open-label, randomized trial to evaluate the safety and efficacy of temporary discontinuation of beta-blocker treatment in patients undergoing transcatheter aortic valve replacement.
- Trial name
- NCT06472934
- Testing
- Transcatheter aortic valve replacement in the absence of B-blocker treatment, Transcatheter aortic valve replacement
- Where
- 11 sites in Austria, Germany and 1 more
- Volunteers
- 498 people
- Sponsor
- University Hospital, Basel, Switzerland
High Degree Second Degree Atrioventricular Block, Complete Heart Block
RAFT-TAVR PACE: LBBAP vs. RVP Post-TAVR in Patients Requiring PPI
The RAFT-TAVR PACE study is a clinical trial designed to compare two types of heart pacing methods in patients who develop conduction problems after undergoing a transcatheter aortic valve replacement (TAVR) procedure.
- Conditions
- High Degree Second Degree Atrioventricular Block, Complete Heart Block, Heart Failure, Transcatheter Aortic Valve Replacement (TAVR)
- Trial name
- RAFT-TAVR PACE (NCT06857201)
- Testing
- Left Bundle Branch Area Pacing, Right Ventricular Pacing
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Acquired Von Willebrand Disease Secondary to Severe Aortic Stenosis, Heye´s Syndrome
Severe Aortic Stenosis and Acquired Von Willebrand´s Disease: The Impact of Desmopressin in Valve-Replacement Surgery
Acquired Von Willebrand disease (type 2A) has been described in patients with severe aortic stenosis, the association of aortic stenosis and Digestive bleeding due to this phenomena has received the name of Heye´s syndrome.
- Conditions
- Acquired Von Willebrand Disease Secondary to Severe Aortic Stenosis, Heye´s Syndrome, Severe Aortic Stenosis
- Trial name
- NCT01994330
- Testing
- desmopressin
- Where
- Chile
- Volunteers
- 13 people
- Sponsor
- Pontificia Universidad Catolica de Chile
Aortic Stenosis, Aortic Insufficiency
Freedom SOLO Stentless Heart Valve Study
The purpose of this clinical investigation is to demonstrate the safety and effectiveness of the Freedom SOLO heart valve.
- Trial name
- SOLO (NCT01115907)
- Testing
- Freedom SOLO Stentless Heart Valve
- Where
- 15 sites in United States, Canada
- Volunteers
- 251 people
- Sponsor
- Sorin Group USA, Inc.
Mitral Insufficiency, Mitral Stenosis
Polish Transcatheter Transfemoral Mitral Valve-in-Valve Implantation (Mitral ViV) Registry
In recent years increasing number of mitral bioprosthesis implantation, especially in elderly population, is observed. Bioprosthetic valves are associated with a lower risk of thrombotic and bleeding adverse events compared with…
- Conditions
- Mitral Insufficiency, Mitral Stenosis, Mitral Stenosis With Insufficiency, Heart Failure
- Trial name
- NCT05625607
- Testing
- Transcatheter mitral valve-in-valve implantation
- Where
- 7 sites in Poland
- Volunteers
- 100 people
- Sponsor
- Medical University of Warsaw
Valvular Disease
Impact of Cardiopulmonary Bypass Time on Gastrointestinal Complications
This retrospective study investigates the relationship between cardiopulmonary bypass (CPB) duration and the incidence of gastrointestinal complications (GICs) in patients undergoing heart valve replacement.
- Trial name
- NCT06697405
- Testing
- Prolonged ≥ 120 minutes
- Where
- China
- Volunteers
- 1,444 people
- Sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu Province