| Primary | Percentage of Participants With First Diagnosis of Clinically Actionable Events (CAE) at 12 Months | Clinically Actionable Events (CAE) are 12 events that were identified based on their relation to other comorbidities that may increase the risk of a serious cardiac event. The CAEs consist of several arrhythmias and device performance parameters such as: Atrial Tachycardia/Atrial Fibrillation (AT/AF) and loss of capture. | | Posted | | Number | | Percentage of participants | | One year post-enrollment | | | | ID | Title | Description |
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| OG000 | Standard of Care With TTM | Pacemaker patients followed by transtelephonic monitoring at 2 month intervals | | OG001 | Remote Pacemaker Interrogation | Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Null hypothesis: control rate = remote rate | Modified Peto-Peto | A one-sided test was used. | <0.0001 | | | | | | | 95 | | | | | | No | Superiority or Other | | |
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| Secondary | Proportion of Actions Taken in Response to the Diagnosis of Clinically Actionable Events | Actions categories include: Referral, Office Visit, Medication (Med) Change, Hospitalization, Emergency Room (ER) Visit, Device Reprogrammed, System Modification, Increase Monitoring, Other | | Posted | | Number | | Total number actions/total number CAEs | | One year post-enrollment | | | | ID | Title | Description |
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| OG000 | Standard of Care With TTM | Pacemaker patients followed by transtelephonic monitoring at 2 month intervals | | OG001 | Remote Pacemaker Interrogation | Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals |
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| Secondary | Percentage of Participants With First Diagnosis of New Onset Atrial Tachycardia/Atrial Fibrillation (AT/AF) at 12 Months | Compare time to first diagnosis in Remote and Control arms | Only participants without a history of Atrial Tachycardia/Atrial Fibrillation were included in analysis of this objective. | Posted | | Number | | Percentage of participants | | One year post-enrollment | | | | ID | Title | Description |
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| OG000 | Standard of Care With TTM | Pacemaker patients followed by transtelephonic monitoring at 2 month intervals | | OG001 | Remote Pacemaker Interrogation | Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals |
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| Secondary | Percentage of Participants With First Diagnosis of Sensed Ventricular Rate Greater Than 100 Beats Per Minute (BPM) During Atrial Tachycardia/Atrial Fibrillation at 12 Months | Compare time to diagnosis in Control and Remote arms | | Posted | | Number | | Percentage of participants | | One year post-enrollment | | | | ID | Title | Description |
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| OG000 | Standard of Care With TTM | Pacemaker patients followed by transtelephonic monitoring at 2 month intervals | | OG001 | Remote Pacemaker Interrogation | Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals |
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| Secondary | Percentage of Participants With First Diagnosis of Atrial Tachycardia/Atrial Fibrillation Greater Than 48 Hours at 12 Months | Compare time to diagnosis in Control and Remote arms | Cohort was subset of full cohort excluding participants with single chamber devices, thus the variance in number analyzed vs other endpoint analyses. | Posted | | Number | | Percentage of participants | | One year post-enrollment | | | | ID | Title | Description |
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| OG000 | Standard of Care With TTM | Pacemaker patients followed by transtelephonic monitoring at 2 month intervals | | OG001 | Remote Pacemaker Interrogation | Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals |
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| Secondary | Percentage of Participants With First Diagnosis of Ventricular Pacing Increase Greater Than 30 Percent at 12 Months | Compare time to first diagnosis in Control and Remote arms | | Posted | | Number | | Percentage of participants | | One year post-enrollment | | | | ID | Title | Description |
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| OG000 | Standard of Care With TTM | Pacemaker patients followed by transtelephonic monitoring at 2 month intervals | | OG001 | Remote Pacemaker Interrogation | Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals |
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| Secondary | Percentage of Participants With First Diagnosis of Non-sustained Ventricular Tachycardia at 12 Months | Compare time to first diagnosis in Control and Remote arms | | Posted | | Number | | Percentage of participants | | One year post-enrollment | | | | ID | Title | Description |
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| OG000 | Standard of Care With TTM | Pacemaker patients followed by transtelephonic monitoring at 2 month intervals | | OG001 | Remote Pacemaker Interrogation | Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals |
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| Secondary | Percentage of Participants With First Diagnosis of Loss of Atrial Capture at 12 Months | Compare time to first diagnosis in Control and Remote arms | Analysis used subset of full cohort excluding participants with single chamber devices, thus the variance in number analyzed. | Posted | | Number | | Percentage of participants | | One year post-enrollment | | | | ID | Title | Description |
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| OG000 | Standard of Care With TTM | Pacemaker patients followed by transtelephonic monitoring at 2 month intervals | | OG001 | Remote Pacemaker Interrogation | Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals |
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| Secondary | Percentage of Participants With First Diagnosis of Loss of Ventricular Capture at 12 Months | Compare time to first diagnosis in Remote and Control arms | | Posted | | Number | | Percentage of participants | | One year post-enrollment | | | | ID | Title | Description |
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| OG000 | Standard of Care With TTM | Pacemaker patients followed by transtelephonic monitoring at 2 month intervals | | OG001 | Remote Pacemaker Interrogation | Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals |
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| Secondary | Percentage of Participants With an Increase in Atrial Pacing Voltage Threshold Greater Than 1 Volt (V) at 12 Months | Compare time to first diagnosis in Remote and Control arms | Cohort was subset of full cohort excluding participants with single chamber devices, thus the variance in number analyzed. | Posted | | Number | | Percentage of participants | | One year post-enrollment | | | | ID | Title | Description |
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| OG000 | Standard of Care With TTM | Pacemaker patients followed by transtelephonic monitoring at 2 month intervals | | OG001 | Remote Pacemaker Interrogation | Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals |
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| Secondary | Percentage of Participants With an Increase in Ventricular Pacing Voltage Threshold Greater Than 1 Volt (V) at 12 Months | Compare time to first diagnosis in Control and Remote arms | | Posted | | Number | | Percentage of participants | | One year post-enrollment | | | | ID | Title | Description |
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| OG000 | Standard of Care With TTM | Pacemaker patients followed by transtelephonic monitoring at 2 month intervals | | OG001 | Remote Pacemaker Interrogation | Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals |
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| Secondary | Percentage of Participants With First Diagnosis of Change in Atrial Lead Impedance at 12 Months | Compare time to first diagnosis in Control and Remote arms | Cohort was subset of full cohort excluding participants with single chamber devices, thus the variance in number analyzed. | Posted | | Number | | Percentage of participants | | One year post-enrollment | | | | ID | Title | Description |
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| OG000 | Standard of Care With TTM | Pacemaker patients followed by transtelephonic monitoring at 2 month intervals | | OG001 | Remote Pacemaker Interrogation | Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals |
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| Secondary | Percentage of Participants With First Diagnosis of Change in Ventricular Lead Impedance at 12 Months | Compare time to first diagnosis in Control and Remote arms | | Posted | | Number | | Percentage of participants | | One year post-enrollment | | | | ID | Title | Description |
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| OG000 | Standard of Care With TTM | Pacemaker patients followed by transtelephonic monitoring at 2 month intervals | | OG001 | Remote Pacemaker Interrogation | Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals |
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| Secondary | Percentage of Participants With First Diagnosis of Elective Replacement Indicator/Battery End of Life (ERI/EOL) at 12 Months | Compare time to first diagnosis in Control and Remote arms | | Posted | | Number | | Percentage of participants | | One year post-enrollment | | | | ID | Title | Description |
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| OG000 | Standard of Care With TTM | Pacemaker patients followed by transtelephonic monitoring at 2 month intervals | | OG001 | Remote Pacemaker Interrogation | Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals |
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