Overview

This trial is active, not recruiting.

Conditions aortic valve insufficiency, aortic aneurysm
Treatments remodeling procedure associated with a subvalvular aortic ring or double sub and supra-valvular aortic annuloplasty, mechanical valve replacement (isolated or composite valve and graft replacement); actual surgical standard for dystrophic aortic roots
Phase phase 3
Sponsor Assistance Publique - Hôpitaux de Paris
Start date May 2007
End date November 2014
Trial size 245 participants
Trial identifier NCT00478803, 2006-A00362-49, P040412

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
aortic valve surgery(Remodeling associated with a subvalvular aortic ring annuloplasty or double sub and supra valvular aortic annuloplasty)
remodeling procedure associated with a subvalvular aortic ring or double sub and supra-valvular aortic annuloplasty External 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.
(Sham Comparator)
Mechanical aortic valve replacement(isolated or composite valve and graft replacement);actual surgical standard for dystrophic aortic roots
mechanical valve replacement (isolated or composite valve and graft replacement); actual surgical standard for dystrophic aortic roots Bentall intervention
Expansible Prosthetic Aortic Ring: Mechanical valve replacement (isolated or composite valve and graft replacement); actual surgical standard for dystrophic aortic roots

Primary Outcomes

Measure
survival free of morbidity or mortality
time frame: 3 years

Secondary Outcomes

Measure
separate analysis of each component of main endpoint composite criteria
time frame: during the 3 years
minor bleeding events
time frame: during the 3 years
Analysis of details of the operative procedures and reasons for intra-operative conversions
time frame: during the intervention and in intensive care
cardiac rhythm (sinus rhythm or not)
time frame: at per-operation andduring the intervention
quality of life (Short Form SF-36)
time frame: during the 3 years
- Cardiac imaging (echocardiographic and CT-scan or MRI): coaptation height, systolic and diastolic diameters of the aortic root at the levels of the base of the aortic annulus, sinuses of valsalva, sino-tubular junction and ascending aorta
time frame: during the surgery and if there is reintervention

Eligibility Criteria

Male or female participants at least 18 years old.

INCLUSION CRITERIA : - Adult patients with indications for elective surgery of aortic root aneurysms (bicuspid or tricuspid valves) conformed to AHA or ESC guidelines or Adult patients with indications for elective surgery of isolated dystrophic aortic insufficiency (bicuspid or tricuspid valves) conformed to AHA or ESC guidelines - signed informed consent EXCLUSION CRITERIA : - Aortic stenosis - Acute ascending aorta dissections - Contra-indications to oral anticoagulation in case of Arm 2 (mechanical valve) - Life expectancy < 36 mois Contra-indication for implantation of the expansible rings in Arm 1: patients are known to have sensitivity to polyester or silicone, the aortic wall is deemed unusually thin and/or friable above the native aortic annular base or local anatomy impairs the safe implantation of the device in the subvalvular position (hypertrophic cardiomyopathy with septal obstruction of the left ventricular outflow tract, calcifications, adhesions…)

Additional Information

Official title Conservative Aortic Valve Surgery for Aortic Insufficiency and Aneurysms of the Aortic Root
Principal investigator Emmanuel LANSAC, MD,PhD
Description The CAVIAAR trial is a multicenter, prospective open trial. Target recruitment is 260 adults with aortic root aneurysms and/or dystrophic aortic insufficiency, enrolled in 19 french centers. Patients will undergo a standardized aortic valve sparing procedure based on aortic annuloplasty or a mechanical valve replacement (130 patients in each arm). In case of valve sparing, per-operative transoesophageal echocardiography will evaluate residual aortic insufficiency after valve repair. A conversion towards a valve replacement will be performed if residual aortic insufficiency is superior or equal to grade II. Analysis will be on an intention-to-treat basis, completed with a per-protocol analysis. Primary endpoint will be 3-years survival free of morbidity or mortality, evaluated on a composite criterion, associating mortality; structural and non-structural valvular dysfunction, valve thrombosis, embolism, bleeding event, endocarditis, reoperations and permanent valve-related impairment. In the valve sparing group, we expect less than 5% rate of operative conversion and a significant improvement of primary endpoint. As secondary goals, quality of life and criteria of valvular coaptation will be compared between the 2 groups. Standardization is the prerequisite for evaluation of valve sparing procedure. Aim of CAVIAAR trial is to provide evidence based medicine data for the best surgical management of patients with aortic root aneurysms and/or dystrophic aortic insufficiency.
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.