Clinical trials: Rapid Deployment Valves
Severe Aortic Valve Disease
Five-year Outcomes of Rapid-deployment Aortic Valve Replacement With the Edwards Intuity TM Valve
Objectives: This report presents 5-year outcomes of the rapid-deployment Edwards Intuity TM valve in a single-center prospective study.
- Trial name
- NCT04696926
- Testing
- Edwards Intuity TM Valve implantation
- Where
- France
- Volunteers
- 170 people
- Sponsor
- Assistance Publique Hopitaux De Marseille
Aortic Valve Replacement, Antithrombotic Therapy
Apixaban for the Prevention of Latent Biological Valve Thrombosis
Background: The optimal antithrombotic strategy early after aortic valve replacement surgery with a biological valve remains controversial due to lack of high-quality evidence.
- Conditions
- Aortic Valve Replacement, Antithrombotic Therapy, Bioprosthetic Valve Thrombosis, Rapid Deployment Valves
- Trial name
- NCT06184113
- Testing
- Aortic valve replacement surgery, Computed tomography, Echocardiography
- Where
- Croatia
- Volunteers
- 166 people
- Sponsor
- Clinical Hospital Centre Zagreb
Aortic Valve Disease, Aortic Stenosis
EDWARDS INTUITY Elite Valve System
The purpose of this active, observational, open-label, non-randomized, post-market surveillance study is to confirm that EDWARDS INTUITY Elite reduces cross clamp time (XCT) in MIS setting when compared to published data with a…
- Trial name
- MISSION (NCT02907463)
- Where
- 23 sites in Austria, Denmark and 7 more
- Volunteers
- 280 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis, Coronary Artery Disease
Registry to Gather Long-time Results After Surgical Aortic Valve Replacement With a "Rapid Deployment Aortic Valve Prothesis (Edwards Intuity) Combined With Bypss Surgery (CABG)
This is a prospctive, unrandomized multicentric registry which will enrol patients with an indication for aortc valve replacement combined with myocardial reperfusion (CABG).
- Trial name
- INCA (NCT03326778)
- Testing
- AVR and CABG
- Where
- Germany
- Volunteers
- 220 people
- Sponsor
- Campus Bad Neustadt
Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency
Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve
The purpose of the clinical study is to prove that the heart valve device is safe, effective, and performs as intended.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence
- Trial name
- TRANSFORM™ (NCT01700439)
- Testing
- EDWARDS INTUITY valve
- Where
- 29 sites in United States
- Volunteers
- 934 people
- Sponsor
- Edwards Lifesciences
CFD, Valve Heart Disease
Computational Assessment of Bioprosthetic Aortic Valve Function
Bioprosthetic valves are usually made of biological tissue that are mounted to a frame and are designed to function similarly to a healthy natural valve.
- Trial name
- NCT06306729
- Testing
- Computed Tomography, Magnetic Resonance Imaging
- Volunteers
- 20 people
- Sponsor
- Royal Brompton & Harefield NHS Foundation Trust
Echocardiography, Aortic Valve
Short- and Medium-term Results of New Generation Aortic
Over the past decade, aortic valve replacement surgery has undergone significant changes in terms of both the approaches and the prostheses used.
- Conditions
- Echocardiography, Aortic Valve, Cardiac Surgery, Mortality
- Trial name
- RVANG (NCT05055089)
- Where
- France
- Volunteers
- 172 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Aortic Valve Disease
Left Bundle Branch Block (LBBB) After IntuityTM
This study aimed to evaluate incidence, prognosis and predictive factors of new-onset of persistent left bundle branch block (LBBB) after rapid-deployment aortic valve replacement (RD-AVR) with the IntuityTM bioprosthesis.
- Trial name
- NCT04897659
- Where
- France
- Volunteers
- 274 people
- Sponsor
- Assistance Publique Hopitaux De Marseille
Aortic Valve Disease, Aortic Stenosis
EDWARDS INTUITY Valve System FOUNDATION Study
The purpose of this active post-market surveillance study is to confirm the safety and effectiveness of the EDWARDS INTUITY Valve System in the study population.
- Conditions
- Aortic Valve Disease, Aortic Stenosis, Rapid Deployment Valves
- Trial name
- FOUNDATION (NCT02338154)
- Where
- 27 sites in Austria, Denmark and 7 more
- Volunteers
- 516 people
- Sponsor
- Edwards Lifesciences