Aortic Valve InsufficiencyPhase 3CAVIAARNCT00478803
Conservative Aortic Valve Surgery for Aortic Insufficiency and Aneurysms of the Aortic Root. CAVIAAR
A Phase 3 study testing Remodeling procedure associated with a subvalvular aortic ring or double sub and supra-valvular aortic annuloplasty and Mechanical valve replacement (isolated or composite valve and graft replacement); actual surgical standard for dystrophic aortic roots in people with Aortic Valve Insufficiency and Aortic Aneurysm, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Insufficiency, Aortic Aneurysm
- What is being tested?
- Remodeling procedure associated with a subvalvular aortic ring or double sub and supra-valvular aortic annuloplasty and Mechanical valve replacement (isolated or composite valve and graft replacement); actual surgical standard for dystrophic aortic roots
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 245 participants
- Where
- 1 siteFrance
- Study dates
- May 2007to Nov 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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…)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Conservative Aortic Valve Surgery for Aortic Insufficiency and Aneurysms of the Aortic Root
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.
Read the 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.
- Conditions
- Aortic Valve Insufficiency, Aortic Aneurysm
- Being tested
- Remodeling procedure associated with a subvalvular aortic ring or double sub and supra-valvular aortic annuloplasty, Mechanical valve replacement (isolated or composite valve and graft replacement); actual surgical standard for dystrophic aortic roots
- 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
- Medical subject headings
- Aortic Valve Insufficiency, Aortic Aneurysm, Aortic Root Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remodeling procedure associated with a subvalvular aortic ring or double sub and supra-valvular aortic annuloplastyProcedure or surgery
Also called External 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.
Mechanical valve replacement (isolated or composite valve and graft replacement); actual surgical standard for dystrophic aortic rootsDevice
Also called Bentall intervention
Expansible Prosthetic Aortic Ring: Mechanical valve replacement (isolated or composite valve and graft replacement); actual surgical standard for dystrophic aortic roots
| Study group | Role | What they receive |
|---|---|---|
| 1, preservation | Experimental | aortic valve surgery(Remodeling associated with a subvalvular aortic ring annuloplasty or double sub and supra valvular aortic annuloplasty) Receives: 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 Receives: Device: Mechanical valve replacement (isolated or composite valve and graft replacement); actual surgical standard for dystrophic aortic roots |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Secondary outcomes (6)
separate analysis of each component of main endpoint composite criteria
Measured: during the 3 years
minor bleeding events
Measured: during the 3 years
Analysis of details of the operative procedures and reasons for intra-operative conversions
Measured: during the intervention and in intensive care
cardiac rhythm (sinus rhythm or not)
Measured: at per-operation andduring the intervention
quality of life (Short Form SF-36)
Measured: 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
Measured: during the surgery and if there is reintervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2007 (estimated)
- Study startMay 2007
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve InsufficiencyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel LANSAC, MD,PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00478803
- Sponsor's protocol ID
- P040412
- Other IDs
- 2006-A00362-49
- Acronym
- CAVIAAR
- Status last verified
- Jul 2012
- First submitted
- 24 May 2007
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1016/j.ejcts.2005.12.055. Epub 2006 Feb 24.
PubMed 16500110Shraer N, Youssefi P, Garufi L, Debauchez M, Lansac E. External aortic annuloplasty with a dedicated expansible ring improves outcomes in remodeling root repair compared with homemade Dacron ring. J Thorac Cardiovasc Surg. 2025 May;169(5):1438-1451.e1. doi: 10.1016/j.jtcvs.2024.06.013. Epub 2024 Jun 22.
PubMed 38914371Shraer N, Youssefi P, Zacek P, Debauchez M, Leprince P, Raisky O, Lansac E. Bicuspid valve repair outcomes are improved with reduction and stabilization of sinotubular junction and annulus with external annuloplasty. J Thorac Cardiovasc Surg. 2024 Jul;168(1):60-73.e6. doi: 10.1016/j.jtcvs.2022.11.021. Epub 2022 Nov 25.
PubMed 36535821Lansac 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.
PubMed 25240525
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative Aortic Valve Surgery for Aortic Insufficiency and Aneurysms of the Aortic Root
- ClinicalTrials.gov ID
- NCT00478803
- Acronym / sponsor ID
- CAVIAAR / P040412
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 25 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1, preservation | Experimental | Procedure: Remodeling procedure associated with a subvalvular aortic ring or double sub and supra-valvular aortic annuloplastyaortic valve surgery(Remodeling associated with a subvalvular aortic ring annuloplasty or double sub and supra valvular aortic annuloplasty) |
| 2, Bentall | Sham comparator | Device: Mechanical valve replacement (isolated or composite valve and graft replacement); actual surgical standard for dystrophic aortic rootsMechanical aortic valve replacement(isolated or composite valve and graft replacement);actual surgical standard for dystrophic aortic roots |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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…)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remodeling procedure associated with a subvalvular aortic ring or double sub and supra-valvular aortic annuloplastyAlso: External aortic annuloplastyRemodeling 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. | Procedure or surgery | 1, preservation |
| Mechanical valve replacement (isolated or composite valve and graft replacement); actual surgical standard for dystrophic aortic rootsAlso: Bentall interventionExpansible Prosthetic Aortic Ring: Mechanical valve replacement (isolated or composite valve and graft replacement); actual surgical standard for dystrophic aortic roots | Device | 2, Bentall |
Primary outcome
survival free of morbidity or mortality
Time frame: 3 years
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
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
- Results publication: PubMed 16500110Lansac 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.
- Derived from this study: PubMed 38914371Shraer N, Youssefi P, Garufi L, Debauchez M, Lansac E. External aortic annuloplasty with a dedicated expansible ring improves outcomes in remodeling root repair compared with homemade Dacron ring. J Thorac Cardiovasc Surg. 2025 May;169(5):1438-1451.e1. doi: 10.1016/j.jtcvs.2024.06.013. Epub 2024 Jun 22.
- Derived from this study: PubMed 36535821Shraer N, Youssefi P, Zacek P, Debauchez M, Leprince P, Raisky O, Lansac E. Bicuspid valve repair outcomes are improved with reduction and stabilization of sinotubular junction and annulus with external annuloplasty. J Thorac Cardiovasc Surg. 2024 Jul;168(1):60-73.e6. doi: 10.1016/j.jtcvs.2022.11.021. Epub 2022 Nov 25.
- Derived from this study: PubMed 25240525Lansac 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel LANSAC, MD,PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Remodeling procedure associated with a subvalvular aortic ring or double sub and supra-valvular aortic annuloplasty and Mechanical valve replacement (isolated or composite valve and graft replacement); actual surgical standard for dystrophic aortic roots in people with Aortic Valve Insufficiency and Aortic Aneurysm, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival free of morbidity or mortality (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00478803, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2015.