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

NCT00478803 | Completed Phase 3 DMC

• 2 other identifiers: P0404122006-A00362-49
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• 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

Study Arms (2)

1, preservation

EXPERIMENTAL

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

2, Bentall

SHAM COMPARATOR

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

Interventions

Remodeling procedure associated with a subvalvular aortic ring or double sub and supra-valvular aortic annuloplasty PROCEDURE

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.

Also known as: External aortic annuloplasty

1, preservation

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

Expansible Prosthetic Aortic Ring: Mechanical valve replacement (isolated or composite valve and graft replacement); actual surgical standard for dystrophic aortic roots

Also known as: Bentall intervention

2, Bentall

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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…)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hopital BICHAT CLAUDE BERNARD

Paris, 75018, France

Location

Related Publications (2)

• 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.

  PMID: 16500110 RESULT

• 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.

  PMID: 25240525 DERIVED

MeSH Terms

Conditions

Aortic Valve Insufficiency; Aortic Aneurysm; Aortic Root Aneurysm

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Aneurysm; Vascular Diseases; Aortic Diseases; Aortic Aneurysm, Thoracic

Study Officials

• Emmanuel LANSAC, MD,PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2007
• First Posted: May 25, 2007
• Study Start: May 1, 2007
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: March 10, 2015

Record last verified: 2012-07

Locations

FR (1)