Conservative Aortic Valve Surgery for Aortic Insufficiency and Aneurysms of the Aortic Root. CAVIAAR

PHASE3CompletedINTERVENTIONAL
Enrollment

245

Participants

Timeline

Start Date

May 31, 2007

Primary Completion Date

November 30, 2014

Study Completion Date

November 30, 2014

Conditions
Aortic Valve InsufficiencyAortic Aneurysm
Interventions
PROCEDURE

Remodeling procedure associated with a subvalvular aortic ring or double sub and supra-valvular aortic annuloplasty

"Remodeling procedure associated with a subvalvular aortic ring: a) Five U stitches are placed inside out in the subvalvular plane (3 stitches 2 mm below the nadir of insertion of each cusp, 2 stitches below 2 of the 3 commissures at the base of the interleaflet triangles (no suture is placed at the base of the interleaflet triangle situated between the right and noncoronary sinuses to avoid injury of the bundle of His)); b) remodeling of the aortic root by scalloping a bulged graft (Gelweave ValsalvaTM); c) The 5 anchoring U stitches are passed through the inner aspect of the prosthetic aortic ring and tied down externally in the subvalvular position; d) anastomosis of the coronary ostia and to distal ascending aorta."

DEVICE

Mechanical valve replacement (isolated or composite valve and graft replacement); actual surgical standard for dystrophic aortic roots

Expansible Prosthetic Aortic Ring: Mechanical valve replacement (isolated or composite valve and graft replacement); actual surgical standard for dystrophic aortic roots

Trial Locations (1)

75018

Hopital BICHAT CLAUDE BERNARD, Paris

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT00478803 - Conservative Aortic Valve Surgery for Aortic Insufficiency and Aneurysms of the Aortic Root. CAVIAAR | Biotech Hunter | Biotech Hunter