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Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00478803 |
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 |
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Aortic Valve Insufficiency |
Procedure: external aortic annuloplasty Device: Expansile Prosthetic Aortic Ring |
Phase III |
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 |
Estimated Enrollment: | 186 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | May 2013 |
Arms | Assigned Interventions |
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1: Experimental
aortic valve sparing
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Procedure: external aortic annuloplasty
external aortic annuloplasty
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2: Sham Comparator
Mechanical aortic valve replacement
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Device: Expansile Prosthetic Aortic Ring
Expansile Prosthetic Aortic Ring
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Emmanuel LANSAC, MD,PhD | +33 (0) 1 40 25 67 02 | emmanuel.lansac@bch.aphp.fr |
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 |
Principal Investigator: | Emmanuel LANSAC, MD,PhD | Assistance Publique - Hôpitaux de Paris |
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 |
Standardized surgical procedure Randomized controlled open trial Aortic Valve sparing Mechanical aortic valve replacement |
Heart Diseases Aortic Valve Insufficiency Aneurysm Heart Valve Diseases |
Heart Diseases Aortic Valve Insufficiency Cardiovascular Diseases Heart Valve Diseases |