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Arrhythmia, Palpitations, Lightheadedness | Validation of an iPhone-based Event Recorder for Arrhythmia Detection

Arrhythmia, Palpitations, Lightheadedness research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Arrhythmia, Palpitations, Lightheadedness

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:Alivecor monitor and 14 day event monitorAlivecor monitor and 14 day event monitor

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Alivecor device and event monitorBoth the Alivecor device (experimental) and the standard of care (event monitor) will be provided to all patients for the duration of the study

Study Status

Unknown status

Start Date: November 2013

Completed Date: May 2016

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Validation of an iPhone-based Event Recorder for Arrhythmia Detection

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Anne Curtis, MD

Lead Sponsor: University at Buffalo

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02005172

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