NCT03647085

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 27, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

August 29, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2019

Completed
Last Updated

June 9, 2022

Status Verified

May 1, 2022

Enrollment Period

4 months

First QC Date

August 23, 2018

Last Update Submit

June 8, 2022

Conditions

Atrial FibrillationAtrial Flutter

Keywords

atrial fibrillationatrial flutterarrhythmia

Outcome Measures

Primary Outcomes (1)

  • Physiologic Signal Detection

    Characterize the impact of Atrial fibrillation (AFib) and Atrial Flutter (AFl) on signals measured using a wearable cardiac monitor prototype device.

    12 months

Study Arms (3)

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.

Device: Wearable cardiac monitor

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.

Device: Wearable cardiac monitor

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.

Device: Wearable cardiac monitor

Interventions

Wearable cardiac monitorDEVICE

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

Group 1 Wearable Cardiac MonitorGroup 2 Wearable Cardiac MonitorGroup 3 Wearable Cardiac Monitor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with paroxysmal AFib or persistent AFib or AFl and scheduled for a cardiac ablation or electrical cardioversion procedure.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Foundation

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Atrial FibrillationAtrial FlutterArrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bruce Johnson, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2018

First Posted

August 27, 2018

Study Start

August 29, 2018

Primary Completion

January 10, 2019

Study Completion

January 10, 2019

Last Updated

June 9, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)