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

NCT ID: NCT01912911

Last Updated: 2014-08-07

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

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Persistent Atrial Fibrillation Paroxysmal Atrial Fibrillation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Khaldoun Tarakji

MD MPH

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Khaldoun Tarajki, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic HVI

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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13-521

Identifier Type: -

Identifier Source: org_study_id

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