Atrial FibrillationSTARBURST-AFNCT07122947
Surveillance Trial of the Apple Watch in Reliable Burden Assessment in Unseen Recurrence of Surgically Treated AF
An observational study of Atrial Fibrillation, run by The Cleveland Clinic at 2 sites in United States.
Trial summary
This is a prospective multicenter clinical study comparing the efficacy of the Apple Watch AFib History tool to the iRhythm Zio Patch monitoring device in quantifying atrial fibrillation (AF) burden after surgical ablation. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Apple Watch: AFib History and Zio Patch
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Jun 2025to 31 Dec 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (>22 years) with a documented history of atrial fibrillation and mitral valve disease who undergo surgical ablation with a Cox-Maze IV concomitant to elective mitral valve surgery.
Who may be able to join
- 22 years of age or older
- Documented or current history of atrial fibrillation (paroxysmal, persistent, or long-standing persistent)
- Undergoing elective mitral valve surgery (repair or replacement) with concomitant surgical ablation using a Cox-Maze IV lesion set and left atrial appendage occlusion procedure, with and without concomitant tricuspid valve procedure (repair or replacement)
- Use or access to Apple iPhone
- Willing and able to provide informed consent and wear both the Apple Watch and Zio Patch at pre-specified intervals for the duration of the study period
- Willing and able to participate in long-term follow up including study visits and surveys
Who cannot join
- Presence of a cardiac pacemaker
- Heart failure with reduced ejection fraction (<40%)
- Concomitant aortic valve replacement or coronary artery bypass graft
- Personal or family history of adhesive skin allergies to adhesives or hydrogels
- Tattoos located on the skin of the wrist or forearm where the Apple Watch will be placed
- Pregnancy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Nadia Bakir, MD, 216-312-4443, bakirn@ccf.org
Marc Gillinov, MD
- Recruiting
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110
Samantha Mulqueeny, RN, 314-273-3905, samantham@wustl.edu
Ralph Damiano Jr., MD
About this study
Official title: Surveillance Trial of the Apple Watch in Reliable Burden Assessment in Unseen Recurrence of Surgically Treated Atrial Fibrillation (STARBURST-AF)
This is a prospective multicenter clinical study comparing the efficacy of the Apple Watch AFib History tool to the iRhythm Zio Patch monitoring device in quantifying atrial fibrillation (AF) burden after surgical ablation. Patients with AF and mitral valve (MV) disease who undergo a Cox-Maze IV procedure concomitant to MV surgery will be evaluated at serial timepoints for up to 1 year postoperatively. The trial will be conducted in the United States at the Cleveland Clinic in Cleveland, OH and at the Washington University School of Medicine in St. Louis, MO.
Read the detailed description
The primary aim of this study is to evaluate the accuracy of current wearable technology using the Apple Watch AFib History tool, relative to ambulatory electrocardiogram (ECG) monitoring using the Zio Patch, for quantifying AF burden after surgical ablation. AF burden will be measured as a weekly estimate, defined as the percentage of time in AF over the prior seven consecutive days. This assessment will occur at 3 months, 6 months, and 1 year postoperatively.
This is a paired study design in which each subject will receive both the investigational device (Apple Watch) and reference device (Zio Patch) concurrently. The study population includes adults over the age of 22 years with a documented history of AF and MV disease undergoing elective MV surgery with concomitant Cox-Maze IV surgical ablation. All participants must be able to provide informed consent and adhere to the study follow-up schedule. Participants who meet the eligibility criteria will be enrolled on a rolling basis. Pre-surgical questionnaires, including Patient-Reported Outcomes Measurement Information System (PROMIS-10), MacNew, and Atrial Fibrillation Severity Scale (AFSS) surveys will be implemented at baseline and serial follow-up.
The monitoring period will be conducted in phases during serial follow-up at 1 month, 3 months, 6 months, and 1 year postoperatively. The Apple Watch will be worn postoperatively for the study duration. Participants will be instructed to charge the device overnight. The Zio Patch 14-day ambulatory ECG monitor will be applied at the following study timepoints: 3 months, 6 months, and 1 year postoperatively. Participants will be instructed to wear the Apple Watch concurrently during Zio Patch monitoring periods, as well as in the interval between visits.
At each follow-up visit (1 month, 3 months, 6 months, and 1 year), participants will undergo standardized evaluations, including a physical exam and the administration of the same standardized questionnaires. Comparative data from the Apple Watch and Zio Patch will be analyzed at the 3 months, 6 months, and 1 year visits.
- Conditions
- Atrial Fibrillation
- Being tested
- Apple Watch: AFib History, Zio Patch
- Keywords
- Wearable, Apple Watch, Atrial Fibrillation, Arrhythmia, Zio Patch, Ambulatory Rhythm Monitoring
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apple Watch: AFib HistoryDevice
Also called Apple Watch Series 10, Photoplethysmography (PPG) Pulse Rhythm Monitoring
The Apple Watch AFib History feature uses PPG pulse rhythm data to detect and quantify the burden of atrial fibrillation.
Zio PatchDevice
Also called iRhythm Zio Patch, Continuous Ambulatory ECG Monitoring
The 14-day Zio Patch monitoring device (iRhythm Technologies, Inc., San Francisco, CA) uses continuous ambulatory ECG monitoring to quantify the burden of atrial fibrillation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of AF burden
This will be measured by comparing the weekly AF burden estimates from the Apple Watch AF History feature to the Zio Patch ambulatory ECG monitoring device. Weekly AF burden is defined as the percentage of time in AF over the prior seven consecutive days and will be measured at 3 months, 6 months, and 1 year postoperatively.
Measured: From enrollment to 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start2 Jun 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (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 The Cleveland ClinicThe 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
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University School of Medicine
- Responsible party
- Principal investigator, Marc Gillinov, MD, The Cleveland Clinic
- Investigators
- Marc Gillinov, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122947
- Sponsor's protocol ID
- 25-458
- Acronym
- STARBURST-AF
- Status last verified
- Sep 2026
- First submitted
- 8 Aug 2025
- Last updated
- 8 Sep 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 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance Trial of the Apple Watch in Reliable Burden Assessment in Unseen Recurrence of Surgically Treated Atrial Fibrillation (STARBURST-AF)
- ClinicalTrials.gov ID
- NCT07122947
- Acronym / sponsor ID
- STARBURST-AF / 25-458
- Conditions
- Atrial Fibrillation
- Keywords
- Wearable, Apple Watch, Atrial Fibrillation, Arrhythmia, Zio Patch, Ambulatory Rhythm Monitoring
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Washington University School of Medicine
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 Aug 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 is a prospective multicenter clinical study comparing the efficacy of the Apple Watch AFib History tool to the iRhythm Zio Patch monitoring device in quantifying atrial fibrillation (AF) burden after surgical ablation. Patients with AF and mitral valve (MV) disease who undergo a Cox-Maze IV procedure concomitant to MV surgery will be evaluated at serial timepoints for up to 1 year postoperatively. The trial will be conducted in the United States at the Cleveland Clinic in Cleveland, OH and at the Washington University School of Medicine in St. Louis, MO.
Detailed description
The primary aim of this study is to evaluate the accuracy of current wearable technology using the Apple Watch AFib History tool, relative to ambulatory electrocardiogram (ECG) monitoring using the Zio Patch, for quantifying AF burden after surgical ablation. AF burden will be measured as a weekly estimate, defined as the percentage of time in AF over the prior seven consecutive days. This assessment will occur at 3 months, 6 months, and 1 year postoperatively.
This is a paired study design in which each subject will receive both the investigational device (Apple Watch) and reference device (Zio Patch) concurrently. The study population includes adults over the age of 22 years with a documented history of AF and MV disease undergoing elective MV surgery with concomitant Cox-Maze IV surgical ablation. All participants must be able to provide informed consent and adhere to the study follow-up schedule. Participants who meet the eligibility criteria will be enrolled on a rolling basis. Pre-surgical questionnaires, including Patient-Reported Outcomes Measurement Information System (PROMIS-10), MacNew, and Atrial Fibrillation Severity Scale (AFSS) surveys will be implemented at baseline and serial follow-up.
The monitoring period will be conducted in phases during serial follow-up at 1 month, 3 months, 6 months, and 1 year postoperatively. The Apple Watch will be worn postoperatively for the study duration. Participants will be instructed to charge the device overnight. The Zio Patch 14-day ambulatory ECG monitor will be applied at the following study timepoints: 3 months, 6 months, and 1 year postoperatively. Participants will be instructed to wear the Apple Watch concurrently during Zio Patch monitoring periods, as well as in the interval between visits.
At each follow-up visit (1 month, 3 months, 6 months, and 1 year), participants will undergo standardized evaluations, including a physical exam and the administration of the same standardized questionnaires. Comparative data from the Apple Watch and Zio Patch will be analyzed at the 3 months, 6 months, and 1 year visits.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (>22 years) with a documented history of atrial fibrillation and mitral valve disease who undergo surgical ablation with a Cox-Maze IV concomitant to elective mitral valve surgery.
Key inclusion criteria (6 listed)
- 22 years of age or older
- Documented or current history of atrial fibrillation (paroxysmal, persistent, or long-standing persistent)
- Undergoing elective mitral valve surgery (repair or replacement) with concomitant surgical ablation using a Cox-Maze IV lesion set and left atrial appendage occlusion procedure, with and without concomitant tricuspid valve procedure (repair or replacement)
- Use or access to Apple iPhone
- Willing and able to provide informed consent and wear both the Apple Watch and Zio Patch at pre-specified intervals for the duration of the study period
Key exclusion criteria (6 listed)
- Presence of a cardiac pacemaker
- Heart failure with reduced ejection fraction (<40%)
- Concomitant aortic valve replacement or coronary artery bypass graft
- Personal or family history of adhesive skin allergies to adhesives or hydrogels
- Tattoos located on the skin of the wrist or forearm where the Apple Watch will be placed
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 |
|---|---|---|
| Apple Watch: AFib HistoryAlso: Apple Watch Series 10, Photoplethysmography (PPG) Pulse Rhythm MonitoringThe Apple Watch AFib History feature uses PPG pulse rhythm data to detect and quantify the burden of atrial fibrillation. | Device | – |
| Zio PatchAlso: iRhythm Zio Patch, Continuous Ambulatory ECG MonitoringThe 14-day Zio Patch monitoring device (iRhythm Technologies, Inc., San Francisco, CA) uses continuous ambulatory ECG monitoring to quantify the burden of atrial fibrillation. | Device | – |
Primary outcome
Accuracy of AF burden
Time frame: From enrollment to 1 year postoperatively
This will be measured by comparing the weekly AF burden estimates from the Apple Watch AF History feature to the Zio Patch ambulatory ECG monitoring device. Weekly AF burden is defined as the percentage of time in AF over the prior seven consecutive days and will be measured at 3 months, 6 months, and 1 year postoperatively.
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 8 Sep 2026.
- Individual participant dataSharing planned: No
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Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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CONVERGE Post-Approval Study (PAS)
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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Atrial Fibrillation (AF)
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.
Marc Gillinov, MD principal investigator
The Cleveland Clinic
2 sites 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, run by The Cleveland Clinic at 2 sites 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 6 inclusion and 6 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 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Nadia Bakir, MD (216-312-4443, bakirn@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of AF burden (time frame: From enrollment to 1 year postoperatively). 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 8 Sep 2026.