Data Collection Atrial Fibrillation Exploratory Study

NCT ID: NCT03647085

Last Updated: 2022-06-09

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 27 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-29
• Study Completion Date: 2019-01-10

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.

Conditions

Atrial Fibrillation; Atrial Flutter

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1 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.

Wearable cardiac monitor

Intervention Type: DEVICE

Participants will be fitted with a wearable cardiac monitor placed on the skin that measures physiologic signals.

Group 2 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.

Wearable cardiac monitor

Intervention Type: DEVICE

Participants will be fitted with a wearable cardiac monitor placed on the skin that measures physiologic signals.

Group 3 Wearable Cardiac Monitor

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

Wearable cardiac monitor

Intervention Type: DEVICE

Participants will be fitted with a wearable cardiac monitor placed on the skin that measures physiologic signals.

Interventions

Wearable cardiac monitor

Participants will be fitted with a wearable cardiac monitor placed on the skin that measures physiologic signals.

Intervention Type: DEVICE

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
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruce Johnson, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic Foundation

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

C2106

Identifier Type: -

Identifier Source: org_study_id