Study of New Implantable Loop Recorder

Completed · Not applicable

Conditions studied: Tachyarrhythmias, Syncope

In brief

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).

Key facts

Study ID

NCT00746564

Run by

Abbott Medical Devices

People needed

75

Starts

2008-09-01

Expected to finish

2014-06-01

Last updated by the study team

2019-01-30

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Alaska Heart Institute — Anchorage, Alaska, United States
• Arizona Arrhythmia Research — Scottsdale, Arizona, United States
• Arkansas Heart Hospital — Little Rock, Arkansas, United States
• St. Jude Hospital — Fullerton, California, United States
• Scripps Clinic — La Jolla, California, United States
• Oklahoma Heart Institute at Utica — Tulsa, Oklahoma, United States
• Providence- St Vincent Medical Center — Portland, Oregon, United States
• Texas Cardiac Arrhythmia Research Foundation — Austin, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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