Status:
UNKNOWN
Evaluation of a Mobile Cardiac Outpatient Telemetry System Versus Standard Loop Event Monitor
Lead Sponsor:
Cardionet
Conditions:
Syncope
Pre-Syncope
Eligibility:
All Genders
18+ years
Brief Summary
Comparing the arrhythmia diagnostic yield of MCOT as compared to standard loop event monitors in patients presenting with palpitations, syncope or near syncope occurring less frequently than every 24 ...
Detailed Description
Cardiac monitoring is used for diagnosing patient with symptoms. Holter monitoring or cardiac loop monitoring are the tests most ofter prescribed for patients depending on the frequency of symptoms. I...
Eligibility Criteria
Inclusion
- syncope, pre-syncope or palpitations less frequently than every 24 hours Pre-syncope without loss of consciousness defined as transient dizziness, leghtheadedness, unsteadiness or weak spells: syncopal events with or without warning: palpitations Subjects with non-diagnostic 24 hours of monitoring related to symptoms within 45 days of enrollment into study Subject able to understand, assent to , and willing to sign the Informed Consent Form.
Exclusion
- Class IV heart failure Post Myocardial infarction less than or equal to 3 months Unstable angina defined as chest pain at rest, new onset of angina, or a change in existing patterns of angina.
- Subjects who are candidatees for or have had recent (less than or equal to 3 monthr) heart valve surgery History of sustained ventricualr tachycardia or ventricular fibrillation documented EF 35% or less with complex ectopy defined as PVC's 10 or greater per hour.
- Subject is less than 18 years old at the time of signing informed consent. Any condition which may prohibit the completion of or compliance with the protocol.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
OBSERVATIONAL
End Date :
October 1 2006
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00295204
Start Date
April 1 2005
End Date
October 1 2006
Last Update
August 3 2006
Active Locations (13)
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1
Medicor Cardiology, PA
Bridgewater, New Jersey, United States, 08807
2
Garden State Cardiovascular Associates
Elizabeth, New Jersey, United States, 07202
3
Monmouth Cardiology Associates, LLC
Ocean City, New Jersey, United States, 07712
4
Cardiovascular Associates of NY
Flushing, New York, United States, 11355