N/A
Completed N=90
DEtermining Accuracy and TrEnding CharacTerization of AF
Source: ClinicalTrials.gov NCT01673256 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcomePrimary: Assess SJM (St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor) Sensitivity and Positive Predictive Values of AF Episodes of at Least 2 Minutes in Length, Utilizing the Data Collected During the Holter Recording. — 83.9; 97.3 percentage
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assess SJM (St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor) Sensitivity and Positive Predictive Values of AF Episodes of at Least 2 Minutes in Length, Utilizing the Data Collected During the Holter Recording. |
83.9; 97.3 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01673256). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.