Determining Accuracy and Trending Characterization of AF
- Conditions
- Atrial fibrillationPalpitations10007521
- Registration Number
- NL-OMON37262
- Lead Sponsor
- St. Jude Medical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
- 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).
- The subject has persistent (>7 days and <1 year or AF 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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To assess SJM Confirm ICM performance through the sensitivity and positive<br /><br>predictive values of AF episodes of at least 2 minutes in length,<br /><br>utilizing the data collected during the Holter recording.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- To assess SJM Confirm ICM performance through the specificity and negative<br /><br>predictive values, utilizing the data collected during the Holter<br /><br>recording.<br /><br>- To assess AF detection of episodes at least 6 minutes in length</p><br>