Evaluating the Efficacy and Feasibility of a Novel Wireless ECG Recording System in Monitoring Patients After Atrial Fibrillation Ablation Procedure

The investigators goal in this study is to examine the feasibility and efficacy of AliveCor iphone case monitoring device in monitoring patients after AF ablation by comparing transmissions using Alive Cor with transmissions from a traditional transtelephonic monitor (TTM).

A secondary goal is to assess the ease of use of AliveCor device compared to traditional TTM system from the patient's perspective

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Key information

Conditions

Persistent Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Paroxysmal Atrial Fibrillation Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic HVI

Cleveland, Ohio, 44195, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male or female between > 18 and < 75 years of age
Paroxysmal or persistent atrial fibrillation
Scheduled to undergo an AF ablation procedure
Already has iPhone 4 or iPhone 4S with data plan
Willing to use the iPhone Alive Cor case
Written informed consent

Exclusion criteria

Unable or unwilling to use the Alive Cor case for their iPhone or iPhone 4S
Residing outside the United States

Treatment and study plan

Primary outcomes

The proportion of AF/flutter events detected by the AliveCor device will be compared to events detected by the TTM for each episode.

Time frame: 3 months

Secondary outcomes

Amount of transmissions from smartphone in comparison with traditional TTM method

Time frame: 3 months

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Acronym: iTransmit

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Jul 31, 2013
Registry last updated: Aug 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed