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

Paroxysmal Atrial Fibrillation Clinical Trial

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Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01912911
• Other study ID #: 13-521
• Status: Completed
• Phase: N/A
• First received: June 7, 2013
• Last updated: August 6, 2014
• Start date: June 2013
• Est. completion date: June 2014

Study information

• Verified date: August 2014
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation
• Persistent Atrial Fibrillation

Locations

Country	Name	City	State
United States	Cleveland Clinic HVI	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of AF/flutter events detected by the AliveCor device will be compared to events detected by the TTM for each episode.		3 months	No
Secondary	Amount of transmissions from smartphone in comparison with traditional TTM method		3 months	No