Factors Influencing Morbi-mortality in Right Anterior Minithoracotomy Approch for Aortic Valve Replacement

Completed

• Conditions: Aortic Valve Disease
• Interventions: Procedure: Aortic valve replacement

• Registration Number: NCT04455165
• Lead Sponsor: Centre Hospitalier La Chartreuse

Brief Summary

Since 2009, positive experiences with right anterior minithoracotomy as an approach to aortic valve replacement are extensively practiced in our institution. The primary disease process for which patients are referred remains aortic stenosis. But more and more, we met older patients with both aortic stenosis and other cardiac pathology (coronary artery disease, other valvulopathy...). Even if minimally invasive valve surgery has been demonstrated to significantly improve postoperative course (reduced blood transfusion, pain, hospital lengths of stay) and to enhance postoperative recovery, when compared with a median sternotomy, it is however important to have medical data and statistics in order to better understand the factors influencing morbi-mortality and thereby to continue this improvement.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-29
• Primary Completion: 2020-06-29
• Study Completion: 2020-06-29
• Study First Submitted: 2020-06-29
• Study First Submitted QC: 2020-06-29
• Status Verified: 2020-07
• Study First Posted: 2020-07-02
• Last Update Submitted: 2020-07-02
• Last Update Posted: 2020-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Patients > 18 y-o who underwent aortic valve replacement

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RVAo MITAVA	Aortic valve replacement	Patient operated since 2009 for aortic valve replacement through right anterior minithoracotomy approch in Dijon Burgundy University Hospital

Primary Outcome Measures

Name	Time	Method
30 days mortality incidence rates	30 days	Mortality from aortic valve replacement to 30 days post-surgery

Secondary Outcome Measures

Name	Time	Method
30 days morbidity incidence rates	30 days	Morbidity from aortic valve replacement to 30 days post-surgery (major adverse cardiac events)
Long-term morbimortality incidence rates	10 years	Morbimortality from aortic valve replacement up to 10 years post-surgery

Trial Locations

Locations (1)

Cardiovascular and thoracic surgery Unit - Dijon University Hopital; 🇫🇷 Dijon, France