Study of New Implantable Loop Recorder

Status:	Completed
Conditions:	Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	2/1/2019
Start Date:	September 2008
End Date:	June 2014

Confirm Implantable Cardiac Monitor Study

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).

Inclusion Criteria:

- 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 Criteria:

- 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

We found this trial at

sites

Providence St. Vincent Medical Center

9205 SW Barnes Rd
Portland, Oregon 97225

(503) 216-1234