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

• Sponsor: Centre Hospitalier La Chartreuse (Other)
• Overall Status: Completed
• CT.gov ID: NCT04455165
• Collaborator: (none)
• Enrollment: 300
• Location: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Disease	Procedure: Aortic valve replacement

Study Design

• Study Type: Observational
• Actual Enrollment: 300 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Factors Influencing Morbi-mortality in Right Anterior Minithoracotomy Approch for Aortic Valve Replacement Operated at Dijon University Hospital
• Actual Study Start Date: Jun 29, 2020
• Actual Primary Completion Date: Jun 29, 2020
• Actual Study Completion Date: Jun 29, 2020

Arms and Interventions

Arm	Intervention/Treatment
RVAo MITAVA Patient operated since 2009 for aortic valve replacement through right anterior minithoracotomy approch in Dijon Burgundy University Hospital	Procedure: Aortic valve replacement; Aortic valve replacement with or without associated cardiac surgery (coronary bypass, mitral valve surgery,...)

Outcome Measures

Primary Outcome Measures

1. 30 days mortality incidence rates [30 days]

   Mortality from aortic valve replacement to 30 days post-surgery

Secondary Outcome Measures

1. 30 days morbidity incidence rates [30 days]

   Morbidity from aortic valve replacement to 30 days post-surgery (major adverse cardiac events)

2. Long-term morbimortality incidence rates [10 years]

   Morbimortality from aortic valve replacement up to 10 years post-surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardiovascular and thoracic surgery Unit - Dijon University Hopital	Dijon		France	21000

Sponsors and Collaborators

• Centre Hospitalier La Chartreuse

Investigators

• Principal Investigator: Marie-Catherine MORGANT, MD, Centre Hospitalier Universitaire Dijon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: MORGANT Marie-Catherine, PI, Centre Hospitalier La Chartreuse
• ClinicalTrials.gov Identifier: NCT04455165
• Other Study ID Numbers: CCVT-RVAoMITAVARegistry
• First Posted: Jul 2, 2020
• Last Update Posted: Jul 7, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Aortic Valve Disease

Study Results

No Results Posted as of Jul 7, 2020