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

Aortic Aneurysm Clinical Trial

— CAVIAAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00478803
• Other study ID #: P040412
• Secondary ID: 2006-A00362-49
• Status: Completed
• Phase: Phase 3
• First received: May 24, 2007
• Last updated: March 6, 2015
• Start date: May 2007
• Est. completion date: November 2014

Study information

• Verified date: July 2012
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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…)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Valve Insufficiency

Intervention

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

Locations

Country	Name	City	State
France	Hopital BICHAT CLAUDE BERNARD	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

Lansac E, Di Centa I, Bonnet N, Leprince P, Rama A, Acar C, Pavie A, Gandjbakhch I. Aortic prosthetic ring annuloplasty: a useful adjunct to a standardized aortic valve-sparing procedure? Eur J Cardiothorac Surg. 2006 Apr;29(4):537-44. Epub 2006 Feb 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival free of morbidity or mortality	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	3 years	No
Secondary	separate analysis of each component of main endpoint composite criteria		during the 3 years	No
Secondary	minor bleeding events		during the 3 years	No
Secondary	Analysis of details of the operative procedures and reasons for intra-operative conversions		during the intervention and in intensive care	No
Secondary	cardiac rhythm (sinus rhythm or not)		at per-operation andduring the intervention	Yes
Secondary	quality of life (Short Form SF-36)		during the 3 years	No
Secondary	- 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	Yes