Data Collection Atrial Fibrillation Exploratory Study

(CAFE Trial)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Boston Scientific Corporation

No Placebo Group

Trial Summary

What is the purpose of this trial?

To characterize the impact of Atrial fibrillation (AFib) and Atrial Flutter (AFl) on signals measured using a wearable cardiac monitor prototype device. To evaluate the relationship of AFib/AFl symptom severity with various physiologic signals measured from the wearable cardiac monitor prototype device.

Research Team

Bruce Johnson, PhD

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

Able to understand and willing to provide written informed consent to participate in the trial

Age 18 years old or greater

Willing and able to participate in study visits and the required testing

Treatment Details

Interventions

• Wearable cardiac monitor (Device)

Participant Groups

Group I: Group 3 Wearable Cardiac Monitor Experimental Treatment 1 Intervention

Patients diagnosed with, and currently in, atrial flutter at the time of enrollment and are scheduled for an ablation or cardioversion.

Group II: Group 2 Wearable Cardiac Monitor Experimental Treatment 1 Intervention

Patients diagnosed with, and currently in, paroxysmal atrial fibrillation at the time of enrollment and are scheduled for an ablation or cardioversion.

Group III: Group 1 Wearable Cardiac Monitor Experimental Treatment 1 Intervention

Patients diagnosed with, and currently in, persistent atrial fibrillation at the time of enrollment and are scheduled for an ablation or cardioversion.

Who Is Running the Clinical Trial?

Boston Scientific Corporation

Lead Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology