The Cardiac FunctionNCT06999681
Postoperative Arrhythmia and Preoperative Cardiac Function
An observational study of The Cardiac Function, run by National Taiwan University Hospital.
Trial summary
This study aims to investigate the association between echocardiographic parameters-including preoperative cardiac echo, as well as postoperative follow-up echocardiography and other associated parameters-and the risk factors related to postoperative arrhythmia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- The Cardiac Function
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 26 May 2025to 31 Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing cardiac surgery
Who may be able to join
- patients receiving cardiac surgery
Who cannot join
- preoperative arrhythmia
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Study on the Association of Perioperative Echocardiographic Parameters and Other Risk Factors With Postoperative Atrial Fibrillation
This study aims to investigate the association between echocardiographic parameters-including preoperative cardiac echo, as well as postoperative follow-up echocardiography and other associated parameters-and the risk factors related to postoperative arrhythmia
Read the detailed description
Postoperative atrial fibrillation (POAF), defined as newly onset atrial fibrillation occurring during hospitalization, is a common complication following cardiac surgery, affecting approximately 20-30% of patients. Studies have shown that patients who develop POAF experience longer hospital stays, incur higher medical costs, and have increased rates of stroke- and heart failure-related complications, as well as higher risks of readmission and mortality.
POAF is generally believed to result from acute perioperative triggers acting on preexisting structural abnormalities of the atria or ventricles. However, the echocardiographic predictors of POAF remain poorly understood. While previous studies have examined the association between preoperative transthoracic echocardiography (TTE)-assessed left atrial and left ventricular function and the development of POAF, the detailed relationship between intraoperative transesophageal echocardiography (TEE)-assessed atrial and ventricular function, its intraoperative changes, and POAF remains insufficiently explored.
This study aims to investigate the association between echocardiographic parameters-including preoperative TTE and TEE, as well as postoperative follow-up parameters-and the risk factors related to POAF.
- Conditions
- The Cardiac Function
- Being tested
- No Interventions
- Keywords
- cardiac echo, cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionsOther
this is an observational cohort study. There was no intervention.
No interventionsOther
No interventions in this study. This study is an observational study.
| Study group | Role | What they receive |
|---|---|---|
| patients with postoperative arrhythmia | patients with postoperative arrhythmia after cardiac surgery Receives: Other: No Interventions | |
| patients without postoperative arrhythmia | patients without postoperative arrhythmia after cardiac surgery Receives: Other: No interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of postoperative arrhythmia
postoperative arrhythmia after cardiac surgery
Measured: postoperative 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start26 May 2025 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Cardiac FunctionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Clinical Trial Center, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06999681
- Sponsor's protocol ID
- 202505037RINE
- Status last verified
- May 2025
- First submitted
- 22 May 2025
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to ethical issue
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on the Association of Perioperative Echocardiographic Parameters and Other Risk Factors With Postoperative Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06999681
- Acronym / sponsor ID
- 202505037RINE
- Conditions
- The Cardiac Function
- Keywords
- cardiac echo, cardiac surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 26 May 2025 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 31 May 2025 (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.
This study aims to investigate the association between echocardiographic parameters-including preoperative cardiac echo, as well as postoperative follow-up echocardiography and other associated parameters-and the risk factors related to postoperative arrhythmia
Detailed description
Postoperative atrial fibrillation (POAF), defined as newly onset atrial fibrillation occurring during hospitalization, is a common complication following cardiac surgery, affecting approximately 20-30% of patients. Studies have shown that patients who develop POAF experience longer hospital stays, incur higher medical costs, and have increased rates of stroke- and heart failure-related complications, as well as higher risks of readmission and mortality.
POAF is generally believed to result from acute perioperative triggers acting on preexisting structural abnormalities of the atria or ventricles. However, the echocardiographic predictors of POAF remain poorly understood. While previous studies have examined the association between preoperative transthoracic echocardiography (TTE)-assessed left atrial and left ventricular function and the development of POAF, the detailed relationship between intraoperative transesophageal echocardiography (TEE)-assessed atrial and ventricular function, its intraoperative changes, and POAF remains insufficiently explored.
This study aims to investigate the association between echocardiographic parameters-including preoperative TTE and TEE, as well as postoperative follow-up parameters-and the risk factors related to POAF.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with postoperative arrhythmia | – | Other: No Interventionspatients with postoperative arrhythmia after cardiac surgery |
| patients without postoperative arrhythmia | – | Other: No interventionspatients without postoperative arrhythmia after cardiac surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing cardiac surgery
Key inclusion criteria (1 listed)
- patients receiving cardiac surgery
Key exclusion criteria (1 listed)
- preoperative arrhythmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Interventionsthis is an observational cohort study. There was no intervention. | Other | patients with postoperative arrhythmia |
| No interventionsNo interventions in this study. This study is an observational study. | Other | patients without postoperative arrhythmia |
Primary outcome
The occurrence of postoperative arrhythmia
Time frame: postoperative 1 years
postoperative arrhythmia after cardiac surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Individual participant dataSharing planned: No. Due to ethical issue
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of The Cardiac Function, run by National Taiwan University Hospital.
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: opening soon, as of the sponsor's last update on 31 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chih-Jun Lai, MD, PhD (+886-972652086, littlecherrytw@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of postoperative arrhythmia (time frame: postoperative 1 years). 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 31 May 2025.