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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Khaldoun Tarakji, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01912911
First received: June 7, 2013
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

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
Persistent Atrial Fibrillation
Paroxysmal Atrial Fibrillation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Amount of transmissions from smartphone in comparison with traditional TTM method [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: June 2013
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Khaldoun Tarakji, MD MPH, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01912911     History of Changes
Other Study ID Numbers: 13-521
Study First Received: June 7, 2013
Last Updated: August 6, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 20, 2014