RECRUITING

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

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.

Conditions

Atrial Fibrillation
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Related Conditions:

Atrial Fibrillation

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Atrial Fibrillation
Intervention / Treatment

-

Contacts and Locations

St. Louis

Washington University School of Medicine in St. Louis, St. Louis, Missouri, United States, 63110

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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

Ages Eligible for Study

22 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The Cleveland Clinic,

Marc Gillinov, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

2027-12-31