Clinical trial NCT00478803: Conservative Aortic Valve Surgery for Aortic Insufficiency and Aneurysms of the Aortic Root. CAVIAAR
Official title: Conservative Aortic Valve Surgery for Aortic Insufficiency and Aneurysms of the Aortic Root
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Aortic Valve Insufficiency
Aortic Aneurysm
Keywords: Standardized surgical procedure
Aortic root aneurysm
Dystrophic aortic insufficiency
Conservative aortic valve surgery
Aortic annuloplasty
Mechanical aortic valve replacement
Sinus of Valsalva
Cardiac Surgical Procedures
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2007-05-25
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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...)

Primary outcomes:
measure: survival free of morbidity or mortality
timeFrame: 3 years
Secondary outcomes:
measure: separate analysis of each component of main endpoint composite criteria
timeFrame: during the 3 years
measure: minor bleeding events
timeFrame: during the 3 years
measure: Analysis of details of the operative procedures and reasons for intra-operative conversions
timeFrame: during the intervention and in intensive care
measure: cardiac rhythm (sinus rhythm or not)
timeFrame: at per-operation andduring the intervention
measure: quality of life (Short Form SF-36)
timeFrame: during the 3 years
measure: - 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
timeFrame: during the surgery and if there is reintervention
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital BICHAT CLAUDE BERNARD
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Emmanuel LANSAC, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/j.ejcts.2005.12.055. Epub 2006 Feb 24.
citation: Lansac E, Bouchot O, Arnaud Crozat E, Hacini R, Doguet F, Demaria R, Leguerrier A, Jouan J, Chatel D, Lopez S, Folliguet T, Acar C, Leprince P, Langanay T, Jegaden O, Bessou JP, Albat B, Latremouille C, Fabiani JN, Fayad G, Fleury JP, Pasquet B, Debauchez M, Di Centa I, Tubach F. Standardized approach to valve repair using an expansible aortic ring versus mechanical Bentall: early outcomes of the CAVIAAR multicentric prospective cohort study. J Thorac Cardiovasc Surg. 2015 Feb;149(2 Suppl):S37-45. doi: 10.1016/j.jtcvs.2014.07.105. Epub 2014 Aug 12.