Data Collection Atrial Fibrillation Exploratory Study

Terminated

• Conditions: Atrial Fibrillation; Atrial Flutter
• Interventions: Device: Wearable cardiac monitor

• Registration Number: NCT03647085
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

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.

Detailed Description

The is a non-randomized feasibility study that will enroll up to 50 participants with an ongoing episode of AFib/AFl and are referred for a cardiac ablation or electrical cardioversion procedure. A maximum of 20 persistent AFib, 20 paroxysmal AFib, and 20 AFl participants will be enrolled, not to exceed 50 total. There will be up to three data collection visits.

Visit 1 will occur on the same day as enrollment and prior to the cardiac ablation or electrical cardioversion procedure. This allows collection of physiologic signals while the patient is in AFib or AFI.

Visit 2 will occur after the cardiac ablation or electrical cardioversion procedure; no earlier than the day after the cardiac ablation or electrical cardioversion procedure and no more than 4 months after the day of the procedure.

Visit 3 is optional, and may be scheduled upon sponsor's request, which will take place at least 5 months after the previous (second) data collection visit.

Study Timeline

• Study First Submitted: 2018-08-23
• Study First Submitted QC: 2018-08-23
• Study First Posted: 2018-08-27
• Study Start: 2018-08-29
• Primary Completion: 2019-01-10
• Study Completion: 2019-01-10
• Status Verified: 2022-05
• Last Update Submitted: 2022-06-08
• Last Update Posted: 2022-06-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 27

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
• Diagnosed with paroxysmal AFib or persistent AFib or AFl and scheduled for a cardiac ablation or electrical cardioversion procedure
• Confirmed AFib/AFl at the time of enrollment

Exclusion Criteria

• Currently enrolled in another clinical trial that may interfere with the placement of study system or include the usage of unapproved drugs
• Participant is pregnant or planning to become pregnant during the study
• Diagnosed with permanent AFib
• Active Implantable Medical Device, e.g. cardiac implantable electronic devices, bladder stimulators, diaphragm stimulators, implantable neuro stimulator, implantable active monitoring devices, implantable active drug administration devices, etc.
• Known allergy to materials used in the study (adhesive tape, ECG electrodes)
• Have a prosthetic cardiac valve or previously underwent cardiac valve surgery.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1 Wearable Cardiac Monitor	Wearable cardiac monitor	Patients diagnosed with, and currently in, persistent atrial fibrillation at the time of enrollment and are scheduled for an ablation or cardioversion.
Group 3 Wearable Cardiac Monitor	Wearable cardiac monitor	Patients diagnosed with, and currently in, atrial flutter at the time of enrollment and are scheduled for an ablation or cardioversion.
Group 2 Wearable Cardiac Monitor	Wearable cardiac monitor	Patients diagnosed with, and currently in, paroxysmal atrial fibrillation at the time of enrollment and are scheduled for an ablation or cardioversion.

Primary Outcome Measures

Name	Time	Method
Physiologic Signal Detection	12 months	Characterize the impact of Atrial fibrillation (AFib) and Atrial Flutter (AFl) on signals measured using a wearable cardiac monitor prototype device.

Trial Locations

Locations (1)

Mayo Clinic Foundation; 🇺🇸 Rochester, Minnesota, United States