MedDataX Logo

Using Smart Phone Technology in Detecting the Presence of Atrial Fibrillation

NCT ID: NCT02214069

Last Updated: 2017-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to examine whether patients can use the AliveCor case to record their heart rhythm and to assess the accuracy of the software in detecting AF vs sinus rhythm

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

AliveCor is a new monitoring technology used with a smart phone which allows patients to record their rhythm. The study will compare AliveCor recordings and automated interpretation of the rhythm with the interpretation by an Electrophysiologist.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation Atrial Flutter

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with Atrial Fibrillation

Patients with Atrial Fibrillation admitted to the hospital for drug loading with Dofetilide or Sotalol willing to record and transmit heart rhythm using AliveCor.

Record and transmit heart rhythm

Intervention Type DEVICE

The patient uses the AliveCor device to record and transmit heart rhythm two times a day. The patient, device software, and Electrophysiologist interpret the rhythm

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Record and transmit heart rhythm

The patient uses the AliveCor device to record and transmit heart rhythm two times a day. The patient, device software, and Electrophysiologist interpret the rhythm

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Male or female between \> 18 and \< 80 years of age
2. Paroxysmal or persistent atrial fibrillation
3. Admitted for antiarrhythmic drug loading (Dofetilide or Sotalol)
4. Already has iPhone 4, 4S or 5 with data plan that accommodates the AliveCor case
5. Willing to use the Alive Cor case
6. Written informed consent

Exclusion Criteria

1. Unable or unwilling to use the Alive Cor case for their smart phone
2. Presence of a permanent pacemaker
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AliveCor

INDUSTRY

Sponsor Role collaborator

The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Khaldoun Tarakji

Staff

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Khaldoun Tarakji, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

William AD, Kanbour M, Callahan T, Bhargava M, Varma N, Rickard J, Saliba W, Wolski K, Hussein A, Lindsay BD, Wazni OM, Tarakji KG. Assessing the accuracy of an automated atrial fibrillation detection algorithm using smartphone technology: The iREAD Study. Heart Rhythm. 2018 Oct;15(10):1561-1565. doi: 10.1016/j.hrthm.2018.06.037. Epub 2018 Aug 22.

Reference Type DERIVED
PMID: 30143448 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

14-612

Identifier Type: -

Identifier Source: org_study_id