Confirm Implantable Cardiac Monitor Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tachyarrhythmias
- Sponsor
- Abbott Medical Devices
- Enrollment
- 75
- Locations
- 9
- Primary Endpoint
- Positive Predictive Value (PPV) for In-Clinic Recordings During Treadmill Stress Test
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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).
Investigators
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
Outcomes
Primary Outcomes
Positive Predictive Value (PPV) for In-Clinic Recordings During Treadmill Stress Test
Time Frame: 6 weeks
The positive predictive value (PPV) for the in-clinic recording was calculated for each recording and for each subject.
Positive Predictive Value (PPV) During Hand to Hand/Shoulder Maneuvers
Time Frame: 6 weeks
The positive predictive value (PPV) for the in-clinic recording was was calculated for each recording and for each subject.
Sensitivity for R Waves During In-Clinic Recordings at Rest
Time Frame: 6 weeks
The sensitivity was calculated for each recording and for each subject.
Sensitivity for R Waves During In-Clinic Recordings During Treadmill Exercise
Time Frame: 6 weeks
The sensitivity for R waves during the in-clinic recordings was was calculated for each recording and for each subject.
Sensitivity for R Waves During In-Clinic Recordings During Hand to Hand/Shoulder Maneuvers
Time Frame: 6 weeks
The sensitivity for R waves during the in-clinic recordings was was calculated for each recording and for each subject.
Positive Predictive Value (PPV) for In-Clinic Recordings at Rest
Time Frame: 6 weeks
The positive predictive value (PPV) for the in-clinic recording was calculated for each recording and for each subject.