Postoperative Atrial FibrillationNCT07173998
Quality of Life in Patients With Postoperative Atrial Fibrillation After Cardiac Surgery
An observational study of Postoperative Atrial Fibrillation, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Prospective observational study on quality of life with postoperative atrial fibrillation after cardiac surgery using SF-36 and qualitative questions Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Postoperative Atrial Fibrillation
- What is being tested?
- Survey
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2025to 1 Jul 2027
- 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 to 100 years
- All sexes
- Adult, Older adult
Study population: Adult patients undergoing cardiac surgery with cardiopulmonary bypass
Who may be able to join
- All genders
- Ages 18-99 years old
- Scheduled to undergo cardiac surgery
- Able to answer survey questions
Who cannot join
- Persistent / permanent atrial fibrillation
- Atrial fibrillation at presentation for surgery
- Emergent operations
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mass General Brigham
Boston, Massachusetts, 02115
Leonard MHK Simeth, BS, 6173529209, lsimeth@bwh.harvard.edu
Jakob Wollborn, MD, jwollborn@bwh.harvard.edu
About this study
Official title: Prospective Observational Study on Quality of Life With Postoperative Atrial Fibrillation
Prospective observational study on quality of life with postoperative atrial fibrillation after cardiac surgery using SF-36 and qualitative questions
Read the detailed description
This is a prospective observational study on quality of life in patients after cardiac surgery with postoperative atrial fibrillation. Patients will answer surveys before their surgery as well as one and three months after their heart operation. The survey includes SF-36, TSQM-9 and qualitative questions.
- Conditions
- Postoperative Atrial Fibrillation
- Being tested
- Survey
- Keywords
- cardiac surgery, recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
SF-36, TSQM-9, qualitative questions
| Study group | Role | What they receive |
|---|---|---|
| Target group | Adult patients undergoing cardiac surgery with cardiopulmonary bypass Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF-36 scores
compare development and absolut SF-36 scores
Measured: before, one month and three months postop
Secondary outcomes (2)
Qualitative questions
exploratory evaluation of qualitative questions
Measured: before, one month and three months postop
TSQM-9 scores
TSQM-9 scores in Afib-patients
Measured: one month and three months postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start15 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Brigham and Women's 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
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jakob Wollborn, MD, Brigham and Women's Hospital
- Investigators
- Jakob Wollborn, MD, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07173998
- Sponsor's protocol ID
- 2025P000238
- Status last verified
- Jun 2026
- First submitted
- 8 Sep 2025
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study on Quality of Life With Postoperative Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT07173998
- Acronym / sponsor ID
- 2025P000238
- Conditions
- Postoperative Atrial Fibrillation
- Keywords
- cardiac surgery, recovery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 15 Sep 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.
Prospective observational study on quality of life with postoperative atrial fibrillation after cardiac surgery using SF-36 and qualitative questions
Detailed description
This is a prospective observational study on quality of life in patients after cardiac surgery with postoperative atrial fibrillation. Patients will answer surveys before their surgery as well as one and three months after their heart operation. The survey includes SF-36, TSQM-9 and qualitative questions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Target group | – | Other: SurveyAdult patients undergoing cardiac surgery with cardiopulmonary bypass |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing cardiac surgery with cardiopulmonary bypass
Key inclusion criteria (4 listed)
- All genders
- Ages 18-99 years old
- Scheduled to undergo cardiac surgery
- Able to answer survey questions
Key exclusion criteria (3 listed)
- Persistent / permanent atrial fibrillation
- Atrial fibrillation at presentation for surgery
- Emergent operations
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 |
|---|---|---|
| SurveySF-36, TSQM-9, qualitative questions | Other | Target group |
Primary outcome
SF-36 scores
Time frame: before, one month and three months postop
compare development and absolut SF-36 scores
2 secondary outcomes
Qualitative questions
Time frame: before, one month and three months postop
TSQM-9 scores
Time frame: one month and three months postop
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 29 Jun 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.
Jakob Wollborn, MD, MPH principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Atrial Fibrillation, run by Brigham and Women's Hospital at 1 site in United States.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Leonard Simeth, cand.med. (+1 6173 529209, lsimeth@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SF-36 scores (time frame: before, one month and three months postop). 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 29 Jun 2026.