Conservative Aortic Valve Surgery for Aortic Insufficiency and Aneurysms of the Aortic Root. CAVIAAR - Full Text View

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00478803

Purpose

The primary objective of the CAVIAAR study is to prove that aortic valve sparing is associated with a 50% 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	Intervention	Phase
Aortic Valve Insufficiency	Procedure: external aortic annuloplasty Device: Expansile Prosthetic Aortic Ring	Phase III

MedlinePlus related topics: Aneurysms Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Conservative Aortic Valve Surgery for Aortic Insufficiency and Aneurysms of the Aortic Root

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

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 [ Time Frame: 3 years ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	186
Study Start Date:	May 2007
Estimated Study Completion Date:	May 2013

Arms	Assigned Interventions
1: Experimental aortic valve sparing	Procedure: external aortic annuloplasty external aortic annuloplasty
2: Sham Comparator Mechanical aortic valve replacement	Device: Expansile Prosthetic Aortic Ring Expansile Prosthetic Aortic Ring

Detailed Description:

The CAVIAAR trial is a multicenter, prospective open randomized trial. Target recruitment is 186 adults with aortic root aneurysms and/or dystrophic aortic insufficiency, enrolled in 29 french centers. Randomization will be held in the operating room, after assessment of aortic valve suitability for the repair: group 1= valve sparing, group 2=mechanical valve replacement. Per-operative transoesophageal echocardiography will evaluate residual aortic insufficiency after valve repair. A conversion towards a mechanical 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 criteria, 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, silent cerebral ischemia and criteria of valvular coaptation will be studied. Standardization is the prerequisite for randomized 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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult patients with indications for elective surgery of aortic root aneurysms and dystrophic aortic insufficiency superiority grade 1 conformed to AHA or ESC guidelines or Adult patients with indications for elective surgery of isolated dystrophic aortic insufficiency conformed to AHA or ESC guidelines
signed informed consent

Exclusion Criteria:

Valvular lesions not amenable to valve repair
Aortic root aneurysms without any significant aortic insufficiency (≤ grade 1)
Long-term indications for oral anticoagulation (arrythmia, intra-auricular thrombus)
Concomitant other cardiac procedures (coronary bypass graft, mitral surgery, aortic arch surgery…)
Acute or chronic ascending aorta dissections
Redo cardiac surgery
Contra-indications to oral anticoagulation treatment or to transoesophageal echocardiography
Life expectancy < 36 mois
Contra-indication for implantation of the expansile ring : 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…)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00478803

Contacts

Contact: Emmanuel LANSAC, MD,PhD

+33 (0) 1 40 25 67 02

emmanuel.lansac@bch.aphp.fr

Locations

France
Hopital BICHAT CLAUDE BERNARD	Recruiting
PARIS, France, 75018
Contact: Emmanuel LANSAC, MD,PhD +33(0) 1 40 25 67 02 emmanuel.lansac@bch.aphp.fr

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Emmanuel LANSAC, MD,PhD

Assistance Publique - Hôpitaux de Paris

More Information

Publications:

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.

Study ID Numbers:	P040412
Study First Received:	May 24, 2007
Last Updated:	November 16, 2007
ClinicalTrials.gov Identifier:	NCT00478803 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Standardized surgical procedure
Randomized controlled open trial
Aortic Valve sparing
Mechanical aortic valve replacement

Study placed in the following topic categories:

Heart Diseases
Aortic Valve Insufficiency
Aneurysm
Heart Valve Diseases

Additional relevant MeSH terms:

Heart Diseases
Aortic Valve Insufficiency
Cardiovascular Diseases
Heart Valve Diseases

ClinicalTrials.gov processed this record on May 07, 2009