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OpenTrials
Completed

NCT Number: NCT07489313

Association of Prosthesis Types for Aortic or Mitral Valve Replacement With Long-term Risk of Mental Disorders

Patients were enrolled if the patients aged 60 to 70 years who underwent surgical aortic or mitral valve replacement. The age range was restricted to 60 to 70 years to ensure comparability in surgical indications between prosthesis types. Patients who underwent concomitant coronary artery bypass grafting or aortic surgery were excluded. To construct a cohort at risk for incident mental disorders, we excluded patients with a diagnosis of depression, anxiety disorder , or sleep disorder within one year prior to the index date. These conditions were identified using International Classification of Diseases, Tenth Revision codes recorded in claims data.

The exposure of interest was the type of prosthetic valve implanted at the index surgery. Patients were classified into mutually exclusive groups based on the prosthesis type recorded at the index procedure. The primary outcome was incident mental disorder after valve replacement, defined as a composite of depression, and anxiety disorder.

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Key information

Age range

60 year–70 year

Sex eligibility

All sexes

Study type

Observational

About this study

Patients were enrolled if the patients aged 60 to 70 years who underwent surgical aortic or mitral valve replacement between January 1, 2013 and December 31, 2023 using procedure codes recorded in inpatient claims (N=5,428). The age range was restricted to 60 to 70 years to ensure comparability in surgical indications between prosthesis types. Patients who underwent concomitant coronary artery bypass grafting or aortic surgery were excluded (n=2,404). To construct a cohort at risk for incident mental disorders, we excluded patients with a diagnosis of depression (n=304), anxiety disorder (n=365), or sleep disorder (n=324) within one year prior to the index date. These conditions were identified using International Classification of Diseases, Tenth Revision codes recorded in claims data.

The exposure of interest was the type of prosthetic valve implanted at the index surgery. Mechanical prostheses were identified using procedure codes G200, G202, and G204, whereas biologic prostheses were identified using codes G201 and G203. Patients were classified into mutually exclusive groups based on the prosthesis type recorded at the index procedure. The primary outcome was incident mental disorder after valve replacement, defined as a composite of depression, and anxiety disorder. Depression was defined using ICD-10 codes F32 and F33. Anxiety disorder was defined using codes F40 and F41.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged 60 to 70 years who underwent surgical aortic or mitral valve replacement between January 1, 2013 and December 31, 2023 using procedure codes recorded in inpatient claims

Exclusion criteria

  • Patients with a diagnosis of depression (n=307), anxiety disorder (n=263), or sleep disorder (n=197) within one year prior to the index date.

Treatment and study plan

Primary outcomes

  1. Incident mental disorder after valve replacement

    Time frame: 5 years after surgery

    Defined as a composite of depression, anxiety disorder, and sleep disorder.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Important dates

Study start
2013
Primary completion
2023
Study completion
2023
First posted
Mar 24, 2026
Registry last updated
May 15, 2026

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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