Evaluation of a Mobile Cardiac Outpatient Telemetry System Versus Standard Loop Event Monitor
1 other identifier
observational
300
1 country
13
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 hours. Patients randomized and are enrolled for 30 days. Prior testing required: 24 hours of non diagnostic monitoring,
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2005
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 21, 2006
CompletedFirst Posted
Study publicly available on registry
February 23, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedAugust 3, 2006
February 1, 2006
February 21, 2006
August 2, 2006
Conditions
Keywords
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cardionetlead
Study Sites (13)
Medicor Cardiology, PA
Bridgewater, New Jersey, 08807, United States
Garden State Cardiovascular Associates
Elizabeth, New Jersey, 07202, United States
Monmouth Cardiology Associates, LLC
Ocean City, New Jersey, 07712, United States
Cardiovascular Associates of NY
Flushing, New York, 11355, United States
Abington Medical Specialists
Abington, Pennsylvania, 19001, United States
Central Bucks Cardiology
Doylestown, Pennsylvania, 18901, United States
Central Bucks Specialitsts, LTD
Doylestown, Pennsylvania, 18901, United States
PA Heart and Vascular Group
Jenkintown, Pennsylvania, 19046, United States
Lancaster Heart and Stroke Foundation
Lancaster, Pennsylvania, 17603, United States
Southwestern PA Cardiology Associates
Pittsburgh, Pennsylvania, 15219, United States
Pottstown Medical Specialistsq
Pottstown, Pennsylvania, 19464, United States
Cardiology Consultants of Phladelphia
Yardley, Pennsylvania, 19067, United States
Virginia Cardiovascular Specialist
Richmond, Virginia, 23226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen Rothman, MD
Mainline Arrhythmia and Cardiology Associates
Study Design
- Study Type
- observational
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 21, 2006
First Posted
February 23, 2006
Study Start
April 1, 2005
Study Completion
October 1, 2006
Last Updated
August 3, 2006
Record last verified: 2006-02