Aortic Stenosis Clinical Trial
Official title:
A Randomized Comparison of the EDWARDS INTUITY Valve System anD commErcially Available Aortic Bioprostheses in Subjects uNdergoing surgiCal Aortic Valve replacEment
The study purpose is to compare the EDWARDS INTUITY valve system with commercially available stented aortic bioprostheses, in patients requiring aortic valve replacement surgery with coronary artery bypass.
This is a randomized study comparing the cross-clamp time (XCT) and cardiopulmonary bypass
time (CPBT) of the EDWARDS INTUITY valve system with any commercially available stented
aortic bioprosthesis, in patients with logistic EuroSCORE 1 ≥ 6 undergoing elective surgical
aortic valve replacement surgery with concomitant coronary bypass grafts.
Additionally, the aim is to gather sufficient data to quantify the effect size of short term
patient benefit outcomes previously identified from literature and finally to explore
additional healthcare resource utilization or health economic endpoints.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04310046 -
Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial
|
N/A | |
Completed |
NCT03332745 -
Mechanism of Decompensation Evaluation - Aortic Stenosis
|
||
Recruiting |
NCT06008080 -
Post-Market Clinical Follow Up Study With Navitor Valve
|
||
Recruiting |
NCT06055751 -
Long Term Evaluation of Cardiac Arrhythmias After Transcatheter Aortic Valve Implantation -The LOCATE Registry
|
||
Active, not recruiting |
NCT04815785 -
Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve System in Patients With Severe Calcific Aortic Stenosis
|
N/A | |
Terminated |
NCT02202434 -
Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement
|
N/A | |
Recruiting |
NCT03029026 -
The Role of Occult Cardiac Amyloid in the Elderly With Aortic Stenosis.
|
||
Active, not recruiting |
NCT02903420 -
A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan)
|
N/A | |
Completed |
NCT02629328 -
CardioCel Tri-leaflet Repair Study
|
N/A | |
Completed |
NCT02306226 -
Symetis ACURATE Neo™ Valve Implantation SAVI TF Registry
|
||
Completed |
NCT01676727 -
ADVANCE Direct Aortic Study
|
||
Withdrawn |
NCT01648309 -
Neuropsychological Testing in Patients Undergoing Transvascular Aortic Valve Implantation
|
N/A | |
Completed |
NCT01422044 -
Risk Prediction in Aortic Stenosis
|
N/A | |
Withdrawn |
NCT00774657 -
Ventricular Remodeling In Patients With Aortic Stenosis Assessed Echocardiography
|
N/A | |
Terminated |
NCT00535899 -
Speckle Tracking Imaging in Patients With Low Ejection Fraction Aortic Stenosis (SPArKLE-AS)
|
N/A | |
Terminated |
NCT05070130 -
OpSens PRIME CLASS
|
||
Completed |
NCT03314857 -
China XT: Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese Population
|
N/A | |
Completed |
NCT04157920 -
Impact of Predilatation Between Self-expanding Valves
|
N/A | |
Enrolling by invitation |
NCT06212050 -
Feasibility, Safety, and Effectiveness of the ACURATE neo2 Transcatheter Heart Valve for Severe Bicuspid Aortic Stenosis
|
||
Recruiting |
NCT05893082 -
Multicenter Feasibility Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
|
N/A |