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

NCT00478803 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 245

Last updated 2015-03-10

No results posted yet for this study

Summary

The primary objective of the CAVIAAR study is to prove that aortic valve sparing for patients with aortic root aneurysms and/or dystrophic aortic insufficiency is associated with a 45% increase of 3 years-survival rate without increased mortality or serious increased morbidity events when compared to mechanical valve replacement.

The main hypothesis of this study is that a standardized procedure of valve sparing based on external aortic annuloplasty in patients with dystrophic aortic insufficiency and/or aortic root aneurysm increases survival rate without increased mortality or serious increased morbidity events when compared with patients undergoing mechanical aortic valve replacement.

Conditions

  • Aortic Valve Insufficiency
  • Aortic 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

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Emmanuel LANSAC, MD,PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00478803 on ClinicalTrials.gov