RECRUITING

Surveillance Trial of the Apple Watch in Reliable Burden Assessment in Unseen Recurrence of Surgically Treated AF

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Surveillance Trial of the Apple Watch in Reliable Burden Assessment in Unseen Recurrence of Surgically Treated Atrial Fibrillation (STARBURST-AF)

Quick Facts

Study Start:2025-06-02
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07122947

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 22 years of age or older
  2. * Documented or current history of atrial fibrillation (paroxysmal, persistent, or long-standing persistent)
  3. * 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)
  4. * Use or access to Apple iPhone
  5. * 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
  6. * Willing and able to participate in long-term follow up including study visits and surveys
  1. * Presence of a cardiac pacemaker
  2. * Heart failure with reduced ejection fraction (\<40%)
  3. * Concomitant aortic valve replacement or coronary artery bypass graft
  4. * Personal or family history of adhesive skin allergies to adhesives or hydrogels
  5. * Tattoos located on the skin of the wrist or forearm where the Apple Watch will be placed
  6. * Pregnancy

Contacts and Locations

Study Contact

Nadia Bakir, MD
CONTACT
216-312-4443
bakirn@ccf.org

Principal Investigator

Marc Gillinov, MD
PRINCIPAL_INVESTIGATOR
The Cleveland Clinic

Study Locations (Sites)

Washington University School of Medicine in St. Louis
St. Louis, Missouri, 63110
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: The Cleveland Clinic

  • Marc Gillinov, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-02
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2025-06-02
Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

  • Wearable
  • Apple Watch
  • Atrial Fibrillation
  • Arrhythmia
  • Zio Patch
  • Ambulatory Rhythm Monitoring

Additional Relevant MeSH Terms

  • Atrial Fibrillation