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OpenTrials
Completed

NCT Number: NCT04455165

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

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.

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Key information

Conditions

Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardiovascular and thoracic surgery Unit - Dijon University Hopital

Dijon, 21000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Aortic valve replacement

Procedure

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

Primary outcomes

  1. 30 days mortality incidence rates

    Time frame: 30 days

    Mortality from aortic valve replacement to 30 days post-surgery

Secondary outcomes

  1. 30 days morbidity incidence rates

    Time frame: 30 days

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

  2. Long-term morbimortality incidence rates

    Time frame: 10 years

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier La Chartreuse

Other

Registry information

Official study title

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

Acronym: RVAOMITAVA

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 2, 2020
Registry last updated
Jul 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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