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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT00478803

Collaborator

(none)

245

Enrollment

Location

Arms

90.1

Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Insufficiency Aortic Aneurysm	Procedure: Remodeling procedure associated with a subvalvular aortic ring or double sub and supra-valvular aortic annuloplasty Device: Mechanical valve replacement (isolated or composite valve and graft replacement); actual surgical standard for dystrophic aortic roots	Phase 3

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

245 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2007

Actual Primary Completion Date :

Nov 1, 2014

Actual Study Completion Date :

Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1, preservation aortic valve surgery(Remodeling associated with a subvalvular aortic ring annuloplasty or double sub and supra valvular aortic annuloplasty)	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. Other Names: External aortic annuloplasty
Sham Comparator: 2, Bentall Mechanical aortic valve replacement(isolated or composite valve and graft replacement);actual surgical standard for dystrophic aortic roots	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 Other Names: Bentall intervention

Arm

Intervention/Treatment

Experimental: 1, preservation

aortic valve surgery(Remodeling associated with a subvalvular aortic ring annuloplasty or double sub and supra valvular aortic annuloplasty)

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.

Other Names:

External aortic annuloplasty

Sham Comparator: 2, Bentall

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

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

Other Names:

Bentall intervention

Outcome Measures

Primary Outcome Measures

survival free of morbidity or mortality [3 years]
Primary endpoint for the CAVIAAR trial will be 3-years survival free of morbidity or mortality, evaluated on a composite criteria, associating mortality; structural and non-structural valvular dysfunction, valve thrombosis, embolism, bleeding event, endocarditis, reoperations and permanent valve-related impairment

Secondary Outcome Measures

separate analysis of each component of main endpoint composite criteria [during the 3 years]
minor bleeding events [during the 3 years]
Analysis of details of the operative procedures and reasons for intra-operative conversions [during the intervention and in intensive care]
cardiac rhythm (sinus rhythm or not) [at per-operation andduring the intervention]
quality of life (Short Form SF-36) [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 [during the surgery and if there is reintervention]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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…)