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 : Unknown
Verified November 2015 by Deepika Narasimha, University at Buffalo.
Recruitment status was: Recruiting
First Posted : December 9, 2013
Last Update Posted : December 2, 2015
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.
- 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.
- 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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Validation of an iPhone-based Event Recorder for Arrhythmia Detection|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||March 2016|
|Estimated Study Completion Date :||May 2016|
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
- Validation of an iPhone-based Event Recorder for Arrhythmia Detection [ Time Frame: one year ]
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
|Contact: Deepika Narasimha, MDfirstname.lastname@example.org|
|Contact: Susan Danzer, RN||716 961 email@example.com|
|United States, New York|
|Buffalo, New York, United States, 14226|
|Contact: Susan Danzer, RN 716-991-9900 firstname.lastname@example.org|
|Contact: Deepika Narasimha, MD email@example.com|
|Principal Investigator: Anne Curtis, MD|
|Sub-Investigator: Deepika Narasimha, MD|
|Principal Investigator:||Anne Curtis, MD||University at Buffalo|