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

August 6, 2014 updated by: Khaldoun Tarakji, The Cleveland Clinic

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic HVI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing A-fib ablations.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Amount of transmissions from smartphone in comparison with traditional TTM method
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: Khaldoun Tarajki, MD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

June 7, 2013

First Submitted That Met QC Criteria

July 29, 2013

First Posted (Estimate)

July 31, 2013

Study Record Updates

Last Update Posted (Estimate)

August 7, 2014

Last Update Submitted That Met QC Criteria

August 6, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-521

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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