Evaluation of a Mobile Cardiac Outpatient Telemetry System Versus Standard Loop Event Monitor

Status unconfirmed

Conditions studied: Syncope, Pre-Syncope, Palpitations

In brief

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 hours. Patients randomized and are enrolled for 30 days. Prior testing required: 24 hours of non diagnostic monitoring,

Key facts

Study ID

NCT00295204

Run by

Cardionet

People needed

300

Starts

2005-04-01

Expected to finish

2006-10-01

Last updated by the study team

2006-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Medicor Cardiology, PA — Bridgewater, New Jersey, United States
• Garden State Cardiovascular Associates — Elizabeth, New Jersey, United States
• Monmouth Cardiology Associates, LLC — Ocean City, New Jersey, United States
• Cardiovascular Associates of NY — Flushing, New York, United States
• Abington Medical Specialists — Abington, Pennsylvania, United States
• Central Bucks Cardiology — Doylestown, Pennsylvania, United States
• Central Bucks Specialitsts, LTD — Doylestown, Pennsylvania, United States
• PA Heart and Vascular Group — Jenkintown, Pennsylvania, United States
• Lancaster Heart and Stroke Foundation — Lancaster, Pennsylvania, United States
• Southwestern PA Cardiology Associates — Pittsburgh, Pennsylvania, United States
• Pottstown Medical Specialistsq — Pottstown, Pennsylvania, United States
• Cardiology Consultants of Phladelphia — Yardley, Pennsylvania, United States
• Virginia Cardiovascular Specialist — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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