Atrial fibrillation Palpitations
Conditions
Interventions
None listed
Sponsors
St. Jude Medical
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
Exclusion criteria: - The subject has persistent (>7 days and 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess SJM Confirm ICM performance through the sensitivity and positive predictive values of AF episodes of at least 2 minutes in length, utilizing the data collected during the Holter recording. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To assess SJM Confirm ICM performance through the specificity and negative predictive values, utilizing the data collected during the Holter recording. - To assess AF detection of episodes at least 6 minutes in length | — |
Countries
Netherlands
Outcome results
None listed