N/A
Completed N=75
Study of New Implantable Loop Recorder
Tachyarrhythmias · Syncope
Source: ClinicalTrials.gov NCT00746564 ↗
Enrolled (actual)
75
Serious AEs
14.7%
Results posted
Apr 2015
Primary outcomePrimary: Sensitivity for R Waves During In-Clinic Recordings at Rest — 100 percentage of recordings
Summary
The goal of this IDE clinical study is to evaluate the quality of the cardiac signal recordings obtained by the St. Jude Medical (SJM) Confirm Implantable Cardiac Monitor (device).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity for R Waves During In-Clinic Recordings at Rest |
100 | — |
| PRIMARY Sensitivity for R Waves During In-Clinic Recordings During Treadmill Exercise |
98.1 | — |
| PRIMARY Sensitivity for R Waves During In-Clinic Recordings During Hand to Hand/Shoulder Maneuvers |
98.0 | — |
| PRIMARY Positive Predictive Value (PPV) for In-Clinic Recordings at Rest |
98.9 | — |
| PRIMARY Positive Predictive Value (PPV) for In-Clinic Recordings During Treadmill Stress Test |
77.1 | — |
| PRIMARY Positive Predictive Value (PPV) During Hand to Hand/Shoulder Maneuvers |
85.0 | — |
Eligibility Criteria
Inclusion Criteria
- Patients who have clinical syndromes or situations at increased risk of cardiac arrhythmias
- Patients who experience transient symptoms that may suggest a cardiac arrhythmia
- Patients who have been previously diagnosed with atrial fibrillation
- Patients who are suspected to have Atrial Fibrillation (AF) but AF has not been documented
- Patients who have provided written informed consent to participate in the study.
Exclusion Criteria
- Patients who are under the age of 18 years
- Patients who have a life expectancy less than 1 year
- Patients who are unable to comply with the follow-up schedule
- Patients who are currently implanted with a pacemaker or defibrillator
- Patients who the physician deems inappropriate for the study
Data sourced from ClinicalTrials.gov (NCT00746564). 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.