Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00478803
Status:
COMPLETED
Last Update Posted:
2015-03-10
First Post:
2007-05-24
Brief Title:
Conservative Aortic Valve Surgery for Aortic Insufficiency and Aneurysms of the Aortic Root CAVIAAR
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Conservative Aortic Valve Surgery for Aortic Insufficiency and Aneurysms of the Aortic Root
Status:
COMPLETED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAVIAAR
Brief Summary:
The primary objective of the CAVIAAR study is to prove that aortic valve sparing for patients with aortic root aneurysms andor 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 andor aortic root aneurysm increases survival rate without increased mortality or serious increased morbidity events when compared with patients undergoing mechanical aortic 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 andor 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 andor 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 andor dystrophic aortic insufficiency
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 andor dystrophic aortic insufficiency
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-A00362-49 | OTHER | IDRCB | None |