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Completed

NCT Number: NCT06782620

Association Between Surgical Aortic Valve Replacement and Long-term Outcomes in 50 to 65-year-olds

The goal of this observational study o is to compare outcomes after either biological or mechanical aortic valve replacement. The main question it aims to answer:

Is survival better after mechanical aortic valve replacement compared to biological aortic valve replacement? Are there less complications and reoperations after mechanical aortic valve replacement compared to biological aortic valve replacement? We perform a retrospective Data Collection of anonymized Austrian health insurance data.

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Key information

Conditions

Aortic Valve Replacement

Age range

50 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna

Vienna, State of Vienna, 1090, Austria

About this study

Objectives: In recent years, age recommendations for the utilization of biological prostheses rather than mechanical prostheses for surgical aortic valve replacement (sAVR) have been significantly reduced. This study evaluated survival rates, major adverse cardiac events (MACEs), and reoperation risks following surgical (sM-AVR) and biological (sB-AVR) AVR, with the aim of providing data to inform optimal prosthesis selection for middle-aged patients between 50 and 65 years.

Methods: A population-based cohort study was conducted using data from the Austrian Health System from 2010 to 2020. Patients undergoing isolated sAVR (n=3761) were categorized into sM-AVR (n=1018) and sB-AVR (n=2743) groups. Propensity score matching (PSM) was applied to balance covariates. The primary endpoint was all-cause mortality. The secondary endpoints included MACEs, reoperation, stroke, bleeding, and post-reoperation survival. Outcomes were assessed using Cox regression and Kaplan-Meier analyses.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age between 50 and 65 years
  • st. p. isolated biological or mechanical aortic valve replacement

Exclusion criteria

  • transcatheter aortic valve implantation (TAVI; MEL codes DB025, DB026, DB021, or XN010) as index procedure
  • age <50 or >65 years
  • concomitant heart surgery or additional procedures during the index operation
  • patients receiving a coronary artery stent (MEL codes DD050 or DD060) within four months before AVR

Treatment and study plan

Primary outcomes

  1. Survival

    Time frame: up to 12 years

    overall Survival

Secondary outcomes

  1. reoperation-free survival

    Time frame: up to 12 years

    reoperation-free survival after either biological or mechanical AVR

  2. reoperation

    Time frame: up to 12 years

    reoperation after either biological or mechanical AVR

  3. MACEs

    Time frame: up to 12 years

    MACEs after either biological or mechanical AVR

  4. heart failure

    Time frame: up to 12 years

    heart failure after either biological or mechanical AVR

  5. embolic stroke or ICH

    Time frame: up to 12 years

    embolic stroke or ICH after either biological or mechanical AVR

  6. myocardial infarction

    Time frame: up to 12 years

    myocardial infarction after either biological or mechanical AVR

  7. non-embolic bleeding

    Time frame: up to 12 years

    non-embolic bleeding after either biological or mechanical AVR

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Association Between Surgical Aortic Valve Replacement and Long-term Outcomes in 50 to 65-year-olds: Results of the AUTHEARTVISIT Study

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jan 20, 2025
Registry last updated
Jan 20, 2025

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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