Aortic or Mitral Valve ReplacementNCT07489313
Association of Prosthesis Types for Aortic or Mitral Valve Replacement With Long-term Risk of Mental Disorders
An observational study of Aortic or Mitral Valve Replacement and Valvular Heart Disease Patients, run by Samsung Medical Center.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 70 years
- Conditions the study is for
- Aortic or Mitral Valve Replacement, Valvular Heart Disease Patients
- How many people
- 1,811 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- 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
Who cannot join
- 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.
About this study
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.
Read the detailed description
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mechanical prostheses | Patients who received mechanical prostheses | |
| Biologic prostheses | Patients who received biologic prostheses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident mental disorder after valve replacement
Defined as a composite of depression, anxiety disorder, and sleep disorder.
Measured: 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start1 Jan 2013
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic or Mitral Valve ReplacementStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,811 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danbee Kang, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489313
- Sponsor's protocol ID
- Prosthesis types
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Prosthesis Types for Aortic or Mitral Valve Replacement With Long-term Risk of Mental Disorders
- ClinicalTrials.gov ID
- NCT07489313
- Acronym / sponsor ID
- Prosthesis types
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,811 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mechanical prostheses | – | –Patients who received mechanical prostheses |
| Biologic prostheses | – | –Patients who received biologic prostheses |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incident mental disorder after valve replacement
Time frame: 5 years after surgery
Defined as a composite of depression, anxiety disorder, and sleep disorder.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic or Mitral Valve Replacement and Valvular Heart Disease Patients, run by Samsung Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incident mental disorder after valve replacement (time frame: 5 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.