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Study of New Implantable Loop Recorder

Sponsored by Abbott Medical Devices

About this trial

Last updated 7 years ago

Study ID

60020941D

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 11 years ago

What is this trial about?

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).

What are the participation requirements?

Yes

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.

No

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