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

Aortic Valve Disease Clinical Trial

— RVAOMITAVA  

Official title:

Factors Influencing Morbi-mortality in Right Anterior Minithoracotomy Approch for Aortic Valve Replacement Operated at Dijon University Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04455165
• Other study ID #: CCVT-RVAoMITAVARegistry
• Status: Completed
• Start date: June 29, 2020
• Est. completion date: June 29, 2020

Study information

• Verified date: July 2020
• Source: Centre Hospitalier La Chartreuse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 29, 2020
• Est. primary completion date: June 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Aortic Valve Disease

Intervention

Procedure:
• Aortic valve replacement
Aortic valve replacement with or without associated cardiac surgery (coronary bypass, mitral valve surgery,...)

Locations

Country	Name	City	State
France	Cardiovascular and thoracic surgery Unit - Dijon University Hopital	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier La Chartreuse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30 days mortality incidence rates	Mortality from aortic valve replacement to 30 days post-surgery	30 days
Secondary	30 days morbidity incidence rates	Morbidity from aortic valve replacement to 30 days post-surgery (major adverse cardiac events)	30 days
Secondary	Long-term morbimortality incidence rates	Morbimortality from aortic valve replacement up to 10 years post-surgery	10 years