Transcatheter Aortic Valve Implantation Versus Standard Surgical Aortic Valve Replacement

Enrolling by invitationOBSERVATIONAL
Enrollment

4,000

Participants

Timeline

Start Date

January 1, 2013

Primary Completion Date

May 1, 2025

Study Completion Date

December 31, 2025

Conditions
Prosthesis SurvivalProsthesis; Cardiac, Heart, Functional Disturbance as Result
Interventions
DEVICE

Transcatheter Aortic Valve Implantation

Patients who are deemed receive TAVI first underwent evaluation of their peripheral arteries before the procedure, in order to separate those eligible for transfemoral placement (TFP) from those who would require transapical placement. Technological advances achieved in the new platforms for the treatment of SHD have allowed the use of reduced size catheters and sheaths in the new armamentarium, favoring the TFP technique. The transcatheter valve (TV) is positioned at the level of the native aortic valve during the final step of valve replacement, when the balloon is inflated within the native valve during a brief period of rapid ventricular pacing. The delivery system i traverses the aorta retrograde over a guidewire from its point of insertion in the femoral artery during the use of TFP. Before balloon inflation, the valve and balloon are collapsed on the catheter and fit within the sheath. After balloon inflation, the calcified native valve is replaced by the expanded TV

PROCEDURE

Bioprothesis

The bioprosthesis is implanted using the SAVR procedure during median sternotomy in extracorporeal circulation. Minimally invasive procedures using a thoracotomy approach and peripheral cannulation have found widespread use.

PROCEDURE

Sutureless

The sutureless is implanted using the SAVR procedure during median sternotomy in extracorporeal circulation. Minimally invasive procedures using a thoracotomy approach and peripheral cannulation have found widespread use.

Trial Locations (1)

93200

Francesco Nappi, Saint-Denis

All Listed Sponsors
collaborator

Henri Mondor University Hospital

OTHER

collaborator

Universita degli Studi di Genova

OTHER

lead

Centre Cardiologique du Nord

OTHER