Study of New Implantable Loop Recorder

Abbott

Status: Completed

Conditions: Syncope; Tachyarrhythmias

Treatments: Device: SJM Confirm

Study type: Interventional

Funder types: Industry

Identifiers

NCT00746564

60020941D

Details and patient eligibility

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).

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

Open Label

Experimental group

Description:

SJM Confirm Device

Treatment:

Device: SJM Confirm