Clinical trials: Valve Replacement
Aortic Valve Stenosis, Aortic Valve Replacement
Effects of Aortic Valve Replacement on Myocardial T1 Values in Severe Aortic Valve Stenosis
Background: Severe aortic valve stenosis (AS) is the commonest valve disease. Aortic valve replacement (AVR) is primarily indicated when symptoms occur and/or when there is a drop in left ventricular ejection fraction.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Replacement, Myocardial Fibrosis, Cardiac Magnetic Resonance
- Trial name
- FIBROTIC (NCT05404100)
- Testing
- Aortic valve replacement
- Where
- Denmark
- Volunteers
- 86 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Critical Illness, Intensive Care
Registration Enabling Study of the Safety and Efficacy of the Use of the Navigator Circulatory Management System
A multicentre, open, RCT to assess the safety and efficacy of the Navigator Guided Circulatory Management System versus conventional care in post-operative cardiac surgery patients.
- Trial name
- NAV-1 (NCT00468247)
- Testing
- Navigator, Conventional care
- Where
- 7 sites in Australia
- Volunteers
- 112 people
- Sponsor
- Applied Physiology Pty Ltd
Aortic Stenosis
Performance and Safety of the Lotus™ Valve With a FLEXible Delivery System
To confirm the acute performance and safety of the Lotus™ Valve Flex System for transcatheter aortic valve replacement (TAVR) in symptomatic patients with severe calcific aortic stenosis who are considered high risk for surgical…
- Trial name
- NCT03043404
- Testing
- Transcatheter aortic valve replacement
- Where
- 2 sites in Australia
- Volunteers
- 4 people
- Sponsor
- Boston Scientific Corporation
Transcatheter Aortic Valve Implantation Prosnosis and Complications
Tryptase Level as a Marker of Complications in Transcatheter Aortic Valve Replacement
An association between mast cells and outcomes of patients undergoing transcatheter aortic valve replacement (TAVR) has not been studied to our knowledge.
- Trial name
- TAVR (NCT03047681)
- Testing
- venous blood withdrawl
- Where
- Israel
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Tel-Aviv Sourasky Medical Center
Heart Valve Disease
D-Dimer Determined Anticoagulation INTENSITY in Patients With Mechanical Valve Replacement
The optimal intensity of oral anticoagulation in China patients undergoing mechanical valve replacements is still controversial due to the different risk profiles of thrombophilia and bleeding in Chinese patients.
- Trial name
- 3D-INTENSITY (NCT01996657)
- Testing
- Warfarin
- Where
- 2 sites in China
- Volunteers
- 772 people, healthy volunteers welcome
- Sponsor
- Wuhan Asia Heart Hospital
Tricuspid Regurgitation
Transcatheter Tricuspid Valve Replacement Using the Lux-Valve Plus System
Tricuspid regurgitation (TR) is a common disease, and the tricuspid valve (TV) is no longer a "forgotten valve". Open heart surgery for isolated TR is uncommonly performed due to high operative risk (8-10% mortality).
- Trial name
- LuxValve (NCT06714500)
- Testing
- LuxValve PLlus
- Where
- Hong Kong
- Volunteers
- 20 people
- Sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
Paroxysmal Atrial Fibrillation, Coronary Artery Disease
Surgical Pulmonary Vein Isolation Efficiency Study
A substantial proportion of patients undergoing elective coronary artery bypass grafting have a history of paroxysmal atrial fibrillation. Paroxysmal atrial fibrillation has adverse short-and long term postoperative effects.
- Trial name
- FIN-PVI (NCT01791218)
- Testing
- CABG, AVR or CABG+AVR and PVI, CABG, AVR or CABG+AVR
- Where
- Finland
- Volunteers
- 2 people
- Sponsor
- Kuopio University Hospital
Valvular Heart Disease
The PROTEMBO C Trial
The PROTEMBO C Trial is an international, multi-center, single arm, non-inferiority study of the safety and performance of using the ProtEmbo System for cerebral embolic protection in subjects with severe native aortic valve…
- Trial name
- NCT04618718
- Testing
- cerebral embolic protection during TAVR
- Where
- 8 sites in Germany, Latvia and 1 more
- Volunteers
- 64 people
- Sponsor
- Protembis GmbH
Aortic Stenosis
REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE
The purpose of this study is to generate clinical evidence on valve safety and performance in subjects treated by redo Transcatheter Aortic Valve Replacement (TAVR).
- Trial name
- RESTORE (NCT06777368)
- Testing
- Medtronic TAV, Edwards TAV
- Where
- 71 sites in United States
- Volunteers
- 225 people
- Sponsor
- Medtronic Cardiovascular
Aortic Stenosis
A Study of Transcatheter Aortic Valve Replacement Case Selection and Valve Sizing Using the ABC Bicuspid Sizing Algorithm
The goal of this study is to learn what effects the ABC Bicuspid Sizing Algorithm has on the clinical outcomes of patients with bicuspid aortic stenosis after having a transcatheter aortic valve replacement (TAVR) using the…
- Trial name
- NCT06991517
- Testing
- The ABC Bicuspid Sizing Algorithm
- Where
- 20 sites in Australia, Canada and 6 more
- Volunteers
- 290 people
- Sponsor
- World Health Research Inc.
Mitral Leaflet Prolapse
V-Chordal Adjustable System for Chordal Replacement in Mitral Valve Insufficiency Due to Leaflet Prolapse
The V-Chordal System is a new technology for mitral repair. The Valtech V-Chordal system, consists in the ability to adjust (elongate or shorten) the neochordae "off-pump" to achieve an optimal coaptation.
- Trial name
- NCT01415947
- Testing
- V Chordal
- Where
- Italy
- Volunteers
- 5 people
- Sponsor
- Edwards Lifesciences
Diseases of Aortic Valve, Aortic Regurgitation Disease
Clinical Trial in China
The purpose of this clinical study is to evaluate the effectiveness and safety of the transcatheter aortic valve system in the treatment of patients with severe aortic regurgitation disease who are at high or prohibitive surgical…
- Trial name
- NCT05580952
- Testing
- Transcatheter aortic valve replacement
- Where
- 15 sites in China
- Volunteers
- 120 people
- Sponsor
- Genesis Medtech Corporation
Aortic Stenosis, Aortic Valve Stenosis
Standardized Invasive Hemodynamics for Elevated Gradients Post TAVR (DISCORDANCE TAVR)
The DISCORDANCE TAVR study will determine the discordance between echocardiography-derived and invasive transaortic gradients, as determined by a consistent and reproducible technique (Standardized Invasive Hemodynamics)…
- Trial name
- NCT04827238
- Testing
- Standardized Invasive Hemodynamics
- Where
- 9 sites in United States, Canada
- Volunteers
- 49 people
- Sponsor
- University of British Columbia
Inflammation, Aortic Valve Stenosis
Is Monocyte/HDL Ratio a Predictor of Mortality in Aortic Valve Surgery
In this study, the investigators aimed to determine whether the preoperative Monocyte/HDL ratio would be a predictor of postoperative mortality and morbidity in patients who underwent aortic valve replacement due to aortic…
- Conditions
- Inflammation, Aortic Valve Stenosis, HDL
- Trial name
- NCT05641584
- Testing
- retrospective data review study
- Where
- Turkey (Türkiye)
- Volunteers
- 1 people
- Sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital