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

NCT04455165 | Completed

• 1 other identifier: CCVT-RVAoMITAVARegistry
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Disease

Outcome Measures

Primary Outcomes (1)

• 30 days mortality incidence rates

  Mortality from aortic valve replacement to 30 days post-surgery

  30 days

Secondary Outcomes (2)

• 30 days morbidity incidence rates

  30 days

• Long-term morbimortality incidence rates

  10 years

Study Arms (1)

RVAo MITAVA

Patient operated since 2009 for aortic valve replacement through right anterior minithoracotomy approch in Dijon Burgundy University Hospital

Procedure: Aortic valve replacement

Interventions

Aortic valve replacement PROCEDURE

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

RVAo MITAVA

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patient operated for aortic valve replacement with or without associated cardiac surgery from 2009 in Dijon University Hospital

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Centre Hospitalier La Chartreuse: lead

Study Sites (1)

Cardiovascular and thoracic surgery Unit - Dijon University Hopital

Dijon, 21000, France

Location

MeSH Terms

Conditions

Aortic Valve Disease

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Marie-Catherine MORGANT, MD

  Centre Hospitalier Universitaire Dijon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 2, 2020
• Study Start: June 29, 2020
• Primary Completion: June 29, 2020
• Study Completion: June 29, 2020
• Last Updated: July 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)