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Validation of an iPhone-based Event Recorder for Arrhythmia Detection

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by University at Buffalo
Sponsor:
Information provided by (Responsible Party):
Deepika Narasimha, University at Buffalo
ClinicalTrials.gov Identifier:
NCT02005172
First received: December 3, 2013
Last updated: November 30, 2015
Last verified: November 2015
  Purpose

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 Intervention
Arrhythmia, Palpitations, Lightheadedness
Device: Alivecor monitor and 14 day event monitor

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Validation of an iPhone-based Event Recorder for Arrhythmia Detection

Resource links provided by NLM:


Further study details as provided by University at Buffalo:

Primary Outcome Measures:
  • Validation of an iPhone-based Event Recorder for Arrhythmia Detection [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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.
  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: NCT02005172

Contacts
Contact: Deepika Narasimha, MD deepikan@buffalo.edu
Contact: Susan Danzer, RN 716 961 9900 susandan@buffalo.edu

Locations
United States, New York
Dent Towers Recruiting
Buffalo, New York, United States, 14226
Contact: Susan Danzer, RN    716-991-9900    susandan@buffalo.edu   
Contact: Deepika Narasimha, MD       deepikan@buffalo.edu   
Principal Investigator: Anne Curtis, MD         
Sub-Investigator: Deepika Narasimha, MD         
Sponsors and Collaborators
University at Buffalo
Investigators
Principal Investigator: Anne Curtis, MD University at Buffalo
  More Information

Responsible Party: Deepika Narasimha, MD, University at Buffalo
ClinicalTrials.gov Identifier: NCT02005172     History of Changes
Other Study ID Numbers: 506493-2 
Study First Received: December 3, 2013
Last Updated: November 30, 2015
Health Authority: United States: University at Buffalo Health Sciences IRB

Keywords provided by University at Buffalo:
arrhythmia, palpitations, lightheadedness

Additional relevant MeSH terms:
Dizziness
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 23, 2016