Aortic Stenosis Clinical Trial
Official title:
Transcatheter Aortic Valve Replacement Versu Surgical Aortix Valve Replacement for Treating Elderly Patients With Severe Aortic Stenosis and Small Aortic Annuli: A Prospective Randomized Study The VIVA Trial
To date, no formal, randomized, prospective, head-to-head comparisons of surgical aortic valve replacement (SAVR) versus transcatheter aortic valve replacement (TAVR) have been undertaken in the severe aortic stenosis (AS) population with small aortic annuli. Objectives of the present study are to compare the hemodynamic performance (incidence of severe PPM and ≥ moderate AR) and clinical outcomes (death, stroke, major or life threatening bleeding) between TAVR and SAVR in patients with severe AS and small aortic annuli.
This is a prospective, multicenter, randomized open-label trial including patients with severe AS and small aortic annulus (mean aortic annuli diameter ˂23mm and minimal diameter ≤21.5mm, evaluated by 3D-CT or 3D-TEE). Patients will be randomized in a 1:1 fashion to either TAVR or SAVR. The TAVR procedure will be performed with the ACURATE neo Aortic Valve, the Edwards SAPIEN 3 valve (20, 23 or 26mm) or the CoreValve Evolut R or Evolut PRO valve system (23 or 26 mm).New iterations of these valve models may also be included. The SAVR procedure will be performed using standard techniques, with no limitation in terms of type and size of the valve prosthesis or surgical procedure (e.g. enlargement of the aortic root). For both TAVR and SAVR, the choice of the type and size of valve, access route (for TAVR), utilization of additional procedures such as root enlargement will be left at the discretion of heart team of the site treating the patient. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04310046 -
Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial
|
N/A | |
| 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
|
||
| Withdrawn |
NCT01648309 -
Neuropsychological Testing in Patients Undergoing Transvascular Aortic Valve Implantation
|
N/A | |
| Completed |
NCT01676727 -
ADVANCE Direct Aortic Study
|
||
| 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 | |
| Completed |
NCT03250806 -
Early Detection of Aortic Stenosis in the Community During Flu Vaccination
|