Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-24 @ 11:30 PM
NCT ID:
NCT01673256
Eligibility 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:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01673256
Study Brief:
Protocol Section:
NCT01673256