DEtermining Accuracy and TrEnding CharacTerization of AF

Abbott

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Device: SJM Confirm ICM

Study type: Observational

Funder types: Industry

Identifiers

NCT01673256

DETECT AF

Details and patient eligibility

About

The objective of this study is to assess the atrial fibrillation (AF) episode detection when using the SJM(St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor).

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The subject has been implanted with a SJM Confirm ICM, DM2102.
• The subject has or is suspected to have paroxysmal AF.
• The subject is ≥ 18 years of age.
• The subject is willing and able to provide written Informed Consent (prior to any investigational related procedure).

Exclusion criteria

• The subject has persistent (>7 days and ≤1 year or requiring cardioversion), longstanding persistent (continuous AF >1 year) or permanent AF (not attempting to restore sinus rhythm).
• The subject has AF of reversible etiology (e.g. electrolyte imbalance, thyroid disease).
• The subject has a contraindication to Holter recording.
• The subject has already received an active implantable medical device other than the SJM Confirm ICM, DM2102.
• The subject is unable to comply with the follow up schedule.
• The subject is participating in another investigational device or drug investigation.
• The subject is pregnant or is planning to become pregnant during the duration of the investigation.

Trial design

90 participants in 1 patient group

SJM Confirm ICM Observational Group

Treatment:

Device: SJM Confirm ICM