Study of New Implantable Loop Recorder

Study Overview
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Brief Summary
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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).

Official Title
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Confirm Implantable Cardiac Monitor Study

Conditions
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Tachyarrhythmias, Syncope

Intervention / Treatment
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* Device: SJM Confirm


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Label<br>SJM Confirm Device | Device: SJM Confirm<br>* All patients in this study will receive the SJM Confirm device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity for R Waves During In-Clinic Recordings at Rest | The sensitivity was calculated for each recording and for each subject. | 6 weeks | 
| Sensitivity for R Waves During In-Clinic Recordings During Treadmill Exercise | The sensitivity for R waves during the in-clinic recordings was was calculated for each recording and for each subject. | 6 weeks | 
| Sensitivity for R Waves During In-Clinic Recordings During Hand to Hand/Shoulder Maneuvers | The sensitivity for R waves during the in-clinic recordings was was calculated for each recording and for each subject. | 6 weeks | 
| Positive Predictive Value (PPV) for In-Clinic Recordings at Rest | The positive predictive value (PPV) for the in-clinic recording was calculated for each recording and for each subject. | 6 weeks | 
| Positive Predictive Value (PPV) for In-Clinic Recordings During Treadmill Stress Test | The positive predictive value (PPV) for the in-clinic recording was calculated for each recording and for each subject. | 6 weeks | 
| Positive Predictive Value (PPV) During Hand to Hand/Shoulder Maneuvers | The positive predictive value (PPV) for the in-clinic recording was was calculated for each recording and for each subject. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Implantable Cardiac Monitor, Arrhythmias, Atrial Fibrillation