Atrial FibrillationNCT04880265
Assessing the Burden of Perioperative Atrial Fibrillation in Patients Undergoing Cardiac Surgery
An observational study of Atrial Fibrillation and Cardiac Surgery, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Background and Significance: In the United States approximately 220,000 patients undergo cardiac surgery per annum. Among potential complications, the incidence of atrial fibrillation (AF) is estimated at 30 - 60 %, and therefore presents the most common adverse event after cardiac surgery. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Atrial Fibrillation, Cardiac Surgery
- What is being tested?
- Vivalink wearable life sensors
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2021to May 2030
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing cardiac surgery
Who may be able to join
- Elective open heart surgery
- Age > 20 years
Who cannot join
- Refusal to participate (patient or health care proxy)
- Participation in other pharmacological trials
- Lack of data or poor data quality which cannot be analyzed for any heart rhythm in 80% of the postoperative study period.
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
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Jochen D Muehlschlegel, MD, MMSc, 617-732-7330, jmuehlschlegel@bwh.harvard.edu
Jochen D Muehlschlegel, MD
About this study
Background and Significance:
In the United States approximately 220,000 patients undergo cardiac surgery per annum. Among potential complications, the incidence of atrial fibrillation (AF) is estimated at 30 - 60 %, and therefore presents the most common adverse event after cardiac surgery. Multiple complications may be associated with AF: Patients are usually subject to an increased length-of-stay in the intensive care unit and in the hospital. Furthermore, the risk for stroke and development of long-term AF is elevated, while further anticoagulation is required putting the patient at risk for bleeding. On average, an additional $10,000 - $20,000 is spent for each patient with AF. However, the exact burden of postoperative AF still remains unknown.
Read more
Specific Aims of Research Project:
- To collect data from an electrocardiogram (EKG) monitoring patch, we aim to accurately determine the prevalence of atrial fibrillation in patients undergoing cardiac surgery at our center.
- To collect data on epidemiological characteristics to investigate risk factors for developing perioperative atrial fibrillation in patients undergoing cardiac surgery. This will allow us to create robust risk prediction models.
- Conditions
- Atrial Fibrillation, Cardiac Surgery
- Being tested
- Vivalink wearable life sensors
- Keywords
- Wearable Device
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivalink wearable life sensorsDevice
Collection of EKG data
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing cardiac surgery | Not described Receives: Device: Vivalink wearable life sensors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial Fibrillation
Atrial Fibrillation
Measured: Up to 30 days after discharge from the hospital
Secondary outcomes (1)
Other arrhythmias
Other arrhythmias
Measured: Up to 30 days after discharge from the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start14 Sep 2021
- Primary completionJul 2027 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 150 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880265
- Sponsor's protocol ID
- 2021P000356
- Status last verified
- Jun 2026
- First submitted
- 6 Apr 2021
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Burden of Perioperative Atrial Fibrillation in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04880265
- Acronym / sponsor ID
- 2021P000356
- Conditions
- Atrial Fibrillation, Cardiac Surgery
- Keywords
- Wearable Device
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 10 May 2021 (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.
Background and Significance:
In the United States approximately 220,000 patients undergo cardiac surgery per annum. Among potential complications, the incidence of atrial fibrillation (AF) is estimated at 30 - 60 %, and therefore presents the most common adverse event after cardiac surgery. Multiple complications may be associated with AF: Patients are usually subject to an increased length-of-stay in the intensive care unit and in the hospital. Furthermore, the risk for stroke and development of long-term AF is elevated, while further anticoagulation is required putting the patient at risk for bleeding. On average, an additional $10,000 - $20,000 is spent for each patient with AF. However, the exact burden of postoperative AF still remains unknown.
Specific Aims of Research Project:
- To collect data from an electrocardiogram (EKG) monitoring patch, we aim to accurately determine the prevalence of atrial fibrillation in patients undergoing cardiac surgery at our center.
- To collect data on epidemiological characteristics to investigate risk factors for developing perioperative atrial fibrillation in patients undergoing cardiac surgery. This will allow us to create robust risk prediction models.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing cardiac surgery | – | Device: Vivalink wearable life sensors |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing cardiac surgery
Key inclusion criteria (2 listed)
- Elective open heart surgery
- Age > 20 years
Key exclusion criteria (3 listed)
- Refusal to participate (patient or health care proxy)
- Participation in other pharmacological trials
- Lack of data or poor data quality which cannot be analyzed for any heart rhythm in 80% of the postoperative study period.
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 |
|---|---|---|
| Vivalink wearable life sensorsCollection of EKG data | Device | Patients undergoing cardiac surgery |
Primary outcome
Atrial Fibrillation
Time frame: Up to 30 days after discharge from the hospital
Atrial Fibrillation
1 secondary outcome
Other arrhythmias
Time frame: Up to 30 days after discharge from the hospital
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 30 Jun 2026.
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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.
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 Atrial Fibrillation and Cardiac Surgery, 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 2 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 30 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 Jakob Wollborn, MD MPH (6175258156, jwollborn@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial Fibrillation (time frame: Up to 30 days after discharge from the hospital). 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 30 Jun 2026.