NCT01912911

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 31, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

August 7, 2014

Status Verified

August 1, 2014

Enrollment Period

1 year

First QC Date

June 7, 2013

Last Update Submit

August 6, 2014

Conditions

Persistent Atrial FibrillationParoxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Amount of transmissions from smartphone in comparison with traditional TTM method

    3 months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing A-fib ablations.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic HVI

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Khaldoun Tarajki, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD MPH

Study Record Dates

First Submitted

June 7, 2013

First Posted

July 31, 2013

Study Start

June 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

August 7, 2014

Record last verified: 2014-08

Locations

US(1)