Status:
COMPLETED
Study of New Implantable Loop Recorder
Lead Sponsor:
Abbott Medical Devices
Conditions:
Tachyarrhythmias
Syncope
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this IDE clinical study is to evaluate the quality of the cardiac signal recordings obtained by the St. Jude Medical (SJM) Confirm Implantable Cardiac Monitor (device).
Eligibility Criteria
Inclusion
- Patients who have clinical syndromes or situations at increased risk of cardiac arrhythmias
- Patients who experience transient symptoms that may suggest a cardiac arrhythmia
- Patients who have been previously diagnosed with atrial fibrillation
- Patients who are suspected to have Atrial Fibrillation (AF) but AF has not been documented
- Patients who have provided written informed consent to participate in the study.
Exclusion
- Patients who are under the age of 18 years
- Patients who have a life expectancy less than 1 year
- Patients who are unable to comply with the follow-up schedule
- Patients who are currently implanted with a pacemaker or defibrillator
- Patients who the physician deems inappropriate for the study
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00746564
Start Date
September 1 2008
End Date
June 1 2014
Last Update
January 30 2019
Active Locations (9)
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1
Alaska Heart Institute
Anchorage, Alaska, United States, 99508
2
Arizona Arrhythmia Research
Scottsdale, Arizona, United States, 85251
3
Arkansas Heart Hospital
Little Rock, Arkansas, United States, 72211
4
St. Jude Hospital
Fullerton, California, United States, 92835-2605