Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00221663
Status:
TERMINATED
Last Update Posted:
2008-08-15
First Post:
2005-09-13
Brief Title:
Conventional Versus Mini-Sternotomy for Aortic Valve Surgery
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
Clinical Trial Comparing a Conventional Median Sternotomy Versus a Minimally Invasive Technique for Aortic Valvular Replacement in Adults
Status:
TERMINATED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Minimally-invasive operative techniques have been introduced in cardiac surgery These techniques may have several advantages such as a decrease in post operative pain lower morbidity and mortality faster recovery and a shorter hospital stay However these advantages have rarely been documented in the setting of a formal randomized controlled trial
Detailed Description:
Background
Minimally invasive techniques for cardiac surgery should be formally evaluated
Design
Randomized single-blind monocentric trial
Interventions Compared
Median sternotomy versus minimally invasive technique
Eligibility Criteria
Indication of isolated aortic valvular replacement preoperative American Society of Anesthesiologists ASA class 3 left ventricular ejection fraction 40
Primary Outcome
Forced expiratory volume and peak expiratory volumesecond at 48 hours
Minimally invasive techniques for cardiac surgery should be formally evaluated
Design
Randomized single-blind monocentric trial
Interventions Compared
Median sternotomy versus minimally invasive technique
Eligibility Criteria
Indication of isolated aortic valvular replacement preoperative American Society of Anesthesiologists ASA class 3 left ventricular ejection fraction 40
Primary Outcome
Forced expiratory volume and peak expiratory volumesecond at 48 hours
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 |
|---|---|---|---|
| 2000-05 | None | None | None |