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Validation of an iPhone-based Event Recorder for Arrhythmia Detection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02005172
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Deepika Narasimha, University at Buffalo

Brief Summary:

In this study, we will evaluate the diagnostic yield of the new AliveCor device versus a 14 day event monitor with the use of both devices simultaneously. We will also examine by means of a questionnaire the compliance, ease of use and patient satisfaction for each device.

Hypothesis:

  1. The AliveCor monitor will be non-inferior to the 14 day event monitor with respect to diagnosis of the arrhythmia responsible for a patient's symptoms.
  2. The AliveCor monitor will have better compliance and acceptability compared to the 14 day event monitor, and thus there will be a greater number of days with recordings from the AliveCor monitor.

Condition or disease Intervention/treatment Phase
Arrhythmia, Palpitations, Lightheadedness Device: Alivecor monitor and 14 day event monitor Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Validation of an iPhone-based Event Recorder for Arrhythmia Detection
Study Start Date : November 2013
Actual Primary Completion Date : March 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Alivecor device and event monitor
Both the Alivecor device (experimental) and the standard of care (event monitor) will be provided to all patients for the duration of the study
Device: Alivecor monitor and 14 day event monitor
Alivecor monitor and 14 day event monitor




Primary Outcome Measures :
  1. Validation of an iPhone-based Event Recorder for Arrhythmia Detection [ Time Frame: one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients >18 years of age with symptoms such as palpitations or pre-syncope suggestive of arrhythmias (usually occurring less frequently than once a day) with prior non-diagnostic ECGs and/or Holter monitoring.

Patients who own an iPhone 4, 4S or 5 device and demonstrate the capability of recording and uploading a test ECG recording at the office visit.

Exclusion Criteria:

  1. Patients <18 years of age.
  2. Patients with a myocardial infarction (MI) within the last three months, and/or known history of sustained VT/VF.
  3. Patients with NYHA class IV heart failure.
  4. Patients with unstable angina.
  5. Patients with syncope as the presenting symptom.
  6. Patients unable to or unwilling to use the device.

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): NCT02005172


Locations
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United States, New York
Dent Towers
Buffalo, New York, United States, 14226
Sponsors and Collaborators
University at Buffalo
Investigators
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Principal Investigator: Anne Curtis, MD University at Buffalo
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Responsible Party: Deepika Narasimha, MD, University at Buffalo
ClinicalTrials.gov Identifier: NCT02005172    
Other Study ID Numbers: 506493-2
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Keywords provided by Deepika Narasimha, University at Buffalo:
arrhythmia, palpitations, lightheadedness
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Dizziness
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Sensation Disorders
Neurologic Manifestations
Signs and Symptoms