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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SJM Confirm ICM Observational Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SJM Confirm ICM | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Sensitivity measures the percentage of the actual duration of AF identified by the Holter monitor (for all AF detections that are ≥2 minutes in duration observed in the study) which are correctly identified as AF by the SJM Confirm ICM. Positive Predictive Value measures the percentage of the duration of AF detected (for all AF detections that are ≥2 minutes in duration observed in the study) by the SJM Confirm that is identified as AF by the Holter monitor. | 4 days after Holter starts |
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Inclusion Criteria:
Exclusion Criteria:
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Primary Care Clinic
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| Name | Affiliation | Role |
|---|---|---|
| Thorsten Lewalter, MD | Isar Heart Center Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rhön-Klinikum, Herz- und Gefäß-Klinik | Bad Neustadt an der Saale | Germany | ||||
| Herz -und Diabeteszentrum |
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| ID | Title | Description |
|---|---|---|
| FG000 | SJM Confirm ICM Observational Group | SJM Confirm ICM |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SJM Confirm ICM Observational Group | SJM Confirm ICM |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Sensitivity measures the percentage of the actual duration of AF identified by the Holter monitor (for all AF detections that are ≥2 minutes in duration observed in the study) which are correctly identified as AF by the SJM Confirm ICM. Positive Predictive Value measures the percentage of the duration of AF detected (for all AF detections that are ≥2 minutes in duration observed in the study) by the SJM Confirm that is identified as AF by the Holter monitor. | Posted | Number | 95% Confidence Interval | percentage | 4 days after Holter starts |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SJM Confirm ICM Observational Group | SJM Confirm ICM |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kyle Brunner | St. Jude Medical Inc. | 651.756.3482 | kbrunner02@sjm.com |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Bad Oeynhausen |
| 32545 |
| Germany |
| Charite, Campus Virchow-Klinikum | Berlin | Germany |
| Klinikum Coburg | Coburg | Germany |
| University of Dresden - Heart Center | Dresden | Germany |
| Klinikum Frankfurt Höchst GmbH | Frankfurt | Germany |
| Klinikum Ingolstadt GmbH | Ingolstadt | 85049 | Germany |
| Herzzentrum Leipzig | Leipzig | Germany |
| Isar Heart Center | Munich | 80331 | Germany |
| Hegau-Bodensee-Kliniken | Singen | Germany |
| Schwarzwald-Baar Klinikum GmbH | Villingen-Schwenningen | Germany |
| Albert Schweitzer Hospital | Dordrecht | Netherlands |
| Hagahospital | The Hague | Netherlands |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 90 |
| 0 |
| 90 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |