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

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ClinicalTrials.gov Identifier: NCT01912911
Recruitment Status : Completed
First Posted : July 31, 2013
Last Update Posted : August 7, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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


Condition or disease
Persistent Atrial Fibrillation Paroxysmal Atrial Fibrillation

Study Design

Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : June 2013
Primary Completion Date : June 2014
Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Amount of transmissions from smartphone in comparison with traditional TTM method [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing A-fib ablations.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01912911


Locations
United States, Ohio
Cleveland Clinic HVI
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Khaldoun Tarajki, MD The Cleveland Clinic
More Information

Responsible Party: Khaldoun Tarakji, MD MPH, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01912911     History of Changes
Other Study ID Numbers: 13-521
First Posted: July 31, 2013    Key Record Dates
Last Update Posted: August 7, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes