| Primary | Time Per Patient From a Clinical Event to a Clinical Decision in Response to Arrhythmias, Cardiovascular (CV) Disease Progression, and Device Issues | Days from device detection of a clinical event to a decision being made in response to the event, as reported by the clinician or as evidenced by device data obtained at interrogation. A clinical event could be any of the following that satisfied pre-specified thresholds: arrhythmias (e.g. at least 12 hours of atrial tachycard/atrial fibrillation in a day), cardiovascular disease progression (e.g. multiple device shocks delivered to terminate a single episode), or device issues (e.g. low battery). | All enrolled subjects who experienced at least one event and satisfied the inclusion/exclusion criteria were included in the analysis. An intention to treat analysis was performed for this objective. | Posted | | Median | Inter-Quartile Range | days | | Enrollment to last visit (up to 15 month post-implant) | | | | ID | Title | Description |
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| OG000 | Remote Arm | Wireless remote monitoring, consisting of 3 components: CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day) Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician. The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action. | | OG001 | In-Office Arm | In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0004.6(1.0 to 13.3)
- OG00122.0(7.0 to 44.2)
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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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| The null hypothesis is that the time from a clinical event to a clinical decision for patients followed through the remote management system is greater than and equal to that of patients receiving only in-office care. | Wilcoxon (Mann-Whitney) | | <0.001 | The a priori threshold for significance was an alpha level of 0.05. | Median Difference (Final Values) | 17.4 | | | | 95 | | | | | | No | Superiority or Other | | |
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| Secondary | Health Care Utilization (HCU) | Count of HCU visits for each HCU type (cardiovascular (CV) hospitalizations, cardiovascular (CV) emergency department (ED), and cardiovascular (CV) unscheduled clinic office/urgent care visits) | 9 remote arm patients and 8 in-office arm patients did not meet the inclusion/exclusion criteria. The remaining 1005 remote arm patients and 975 in-office arm patients were included in the analysis. An intention to treat analysis was performed for this objective. | Posted | | Number | | Visits | | Enrollment to last visit (up to 15 month post-implant) | | | | ID | Title | Description |
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| OG000 | Remote Arm | Wireless remote monitoring, consisting of 3 components: CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day) Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician. The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action. | | OG001 | In-Office Arm |
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| Secondary | Health Care Utilization: TEEs | Count of Transesophageal echocardiograms (TEEs) performed | 9 remote arm patients and 8 in-office arm patients did not meet the inclusion/exclusion criteria. The remaining 1005 remote arm patients and 975 in-office arm patients were included in the analysis. An intention to treat analysis was performed for this objective. | Posted | | Number | | Procedures | | Enrollment to last visit (up to 15 months post-implant) | | | | ID | Title | Description |
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| OG000 | Remote Arm | Wireless remote monitoring, consisting of 3 components: CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day) Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician. The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action. | | OG001 | In-Office Arm | In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit |
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| Secondary | Actions Taken for HCU Visits | Count of HCU visits that involved specific actions taken | | Posted | | Number | | Visits | | Enrollment to last visit (up to 15 month post-implant) | | | | ID | Title | Description |
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| OG000 | Remote Arm | Wireless remote monitoring, consisting of 3 components: CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day) Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician. The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action. | | OG001 | In-Office Arm | In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit |
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| Secondary | Clinically Meaningful Alerts | Count of clinically meaningful alerts as classified by the clinician | All enrolled remote subjects who experienced at least one alert were included in the analysis. Alerts that were not classified by the clinician as clinically meaningful or not were excluded from the analysis. | Posted | | Number | | Alerts | | Enrollment to last visit (up to 15 month post-implant) | Events | Participants | | ID | Title | Description |
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| OG000 | Remote Arm | Wireless remote monitoring, consisting of 3 components: CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day) Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician. The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action. |
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| Secondary | Symptomatic AT/AF Alerts | AT/AF represents atrial tachycardia or atrial fibrillation which are arrhythmias involving rapid beating of the atrial chambers of the heart. The devices in this study store how many hours each day that a patient experiences AT/AF. The patient may not be aware they are experiencing these atrial arrhythmias, but if the AT/AF is accompanied by symptoms, the AT/AF is said to be symptomatic AT/AF. Devices in this study have an alert that fires if the patient experiences at least a programmed amount of AT/AF in a day. Measure is count of symptomatic AT/AF alerts as classified by the clinician | All enrolled remote patients who experienced at least one AT/AF alert were included in the analysis. AT/AF alerts there were not classified by the clinician as symptomatic or asymptomatic were excluded from the analysis. | Posted | | Number | | Alerts | | Enrollment to last visit (up to 15 month post-implant) | Events | Participants | | ID | Title | Description |
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| OG000 | Remote Arm | Wireless remote monitoring, consisting of 3 components: CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day) Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician. The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action. |
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| Secondary | AT/AF Alert Treatment | Count of the treatment (i.e. hospitalization, ED visit, unscheduled clinic office/urgent care visits) in response to the AT/AF alerts | All enrolled remote patients who had at least one AT/AF alert were included in the analysis. | Posted | | Number | | Alerts | | Enrollment to last visit (up to 15 month post-implant) | Events | Participants | | ID | Title | Description |
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| OG000 | Remote Arm | Wireless remote monitoring, consisting of 3 components: CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day) Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician. The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action. |
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| Secondary | Time Per Patient From a Clinical Event Onset to a Clinical Decision for Symptom-driven Device Interrogations | Days from a symptom-driven device interrogation event onset to a clinical decision being made in response to the event as reported by the clinician. An event is defined as a subject complaint received by the managing clinician in which the clinician determines that he/she must interrogate the subject's device to properly treat the subject. | All enrolled subjects who experienced at least one event and satisfied the inclusion/exclusion criteria were included in the analysis. | Posted | | Mean | Standard Deviation | Days | | Enrollment to last visit (up to 15 month post-implant) | | | | ID | Title | Description |
|---|
| OG000 | Remote Arm | Wireless remote monitoring, consisting of 3 components: CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day) Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician. The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action. | |
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| Secondary | Time Per Patient From a Clinical Event Onset to a Clinical Decision for Both Device Events and Symptom-driven Device Interrogations | Days from device detection of a clinical event or a symptom-driven device interrogation event onset to a clinical decision, as reported by the clinician or as evidenced by device data obtained at interrogation. A clinical event is an event as defined in the primary objective. A symptom-driven device interrogation event is defined as a subject complaint received by the managing clinician in which the clinician determines that he/she must interrogate the subject's device to properly treat the subject. | All enrolled subjects who experienced at least one event and satisfied the inclusion/exclusion criteria were included in the analysis. | Posted | | Mean | Standard Deviation | Days | | From event onset to clinical decision | | | | ID | Title | Description |
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| OG000 | Remote Arm | Wireless remote monitoring, consisting of 3 components: CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day) Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician. The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action. |
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| Other Pre-specified | Length of Hospital Stay (LOS) | LOS per cardiovascular hospitalization | All enrolled subjects who satisfied the inclusion/exclusion criteria and had at least one cardiovascular hospitalization were included in the analysis. | Posted | | Mean | Standard Error | Days | | Enrollment to last visit (up to 15 month post-implant) | | | | ID | Title | Description |
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| OG000 | Remote Arm | Wireless remote monitoring, consisting of 3 components: CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day) Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician. The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action. | | OG001 | In-Office Arm | In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit |
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| Secondary | CareLink Transmission Compliance | The CareLink Transmission Compliance Rate for a particular visit (e.g. 3 month visit) is the proportion (ranging from 0 to 1) of subjects with device interrogation data remotely transmitted via the CareLink system on the date it was scheduled to be sent for that visit. The proportion is a fraction in which the denominator is the number of subjects in the Remote Arm who were not exited from the trial prior to the visit of interest, and the numberator is the number of Remote Arm subjects who successfully transmitted device data via the CareLink system on the date it was scheduled to be sent. | 9 of 1014 remote arm subjects did not meet the inclusion/exclusion criteria and were excluded from the analysis. The remaining 1005 remote arm subjects were included in the analysis. | Posted | | Mean | 95% Confidence Interval | Proportion of subjects | | 3, 6, 9, 12 months visits | | | | ID | Title | Description |
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| OG000 | Remote Arm | Wireless remote monitoring, consisting of 3 components: CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day) Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician. The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action. |
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| Secondary | Variability in Left Ventricular (LV) Threshold as Measured by Left Ventricular Capture Management (LVCM) | LV Capture Threshold is the required energy(volts) necessary to cause the left ventricule to contract. It is important that a device which paces the left ventricule be set to a threshold such that current conducted through the left ventricular lead will induce contraction in the left ventricle. However, these thresholds may vary over time. The standard deviation and range (maximum LVCM threshold - minimum LVCM threshold) of the most recent 14 days of LVCM results prior to each follow-up visit were determined for each subject and used to assess within-patient variability in LV thresholds. | All enrolled subjects who were implanted with a Concerto CRT-D (Cardiac Resynchronization Therapy with Defibrillation)device, met inclusion/exclusion criteria, and had daily LVCM measurement for at least one of the 6 scheduled visits/transmissions were included in the analysis. | Posted | | Mean | Standard Deviation | Volts | | 1, 3, 6, 9, 12, and 15 months visits | | | | ID | Title | Description |
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| OG000 | Patients With a Study CRT-D Device | Patients in either the Remote Arm or the In-office Arm who were implanted with a study CRT-D Device, as these are the only devices that have Left Ventricular leads |
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| Secondary | State-Anxiety Scale | The State-Anxiety scales for each subject were obtained at multiple time points. The State-Anxiety scale was derived by summing the 20 scores in the State section of the State-Trait Anxiety Inventory (STAI) questionnaire. The State-Anxiety scales can vary from a minimum of 20 (best possible) to a maximum of 80 (worst possible). | All enrolled subjects who completed the STAI questionnaire for all scheduled follow-up visits/transmissions that occurred within specified visit windows and satisfied the inclusion/exclusion criteria were included in the analysis. | Posted | | Mean | Standard Deviation | Scores on a scale | | 1, 3, 6, 9, 12, and 15 month visit | | | | ID | Title | Description |
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| OG000 | Remote Arm | Wireless remote monitoring, consisting of 3 components: CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day) Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician. The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action. | |
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| Secondary | Trait-Anxiety Scale | The Trait-Anxiety scales for each subject were obtained at multiple time points. The Trait-Anxiety scale was derived by summing the 20 scores in the Trait section of the STAI questionnaire. The Trait-Anxiety scales can vary from a minimum of 20 (best possible) to a maximum of 80 (worst possible). | All enrolled subjects who completed the STAI questionnaire for all scheduled follow-up visits/transmissions that occurred within specified visit windows and satisfied the inclusion/exclusion criteria were included in the analysis. | Posted | | Mean | Standard Deviation | Scores on a scale | | 1, 3, 6, 9, 12, and 15 months visits | | | | ID | Title | Description |
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| OG000 | Remote Arm | Wireless remote monitoring, consisting of 3 components: CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day) Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician. The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action. | | OG001 |
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| Secondary | Clinic Personnel Satisfaction With Wireless Telemetry (Telemetry + Leadless ECG). | Following the completion of enrollment in the study, participating clinicians were asked to complete a survey assessing their overall satisfaction with the wireless telemetry feature. Clinicians' rating (1=strongly disagree, 5=strongly agree) of the overall satisfaction with the wireless telemetry feature of the device | All surveys in which clinician completed at least a subset of the questions were included. | Posted | | Mean | Standard Deviation | Units on a scale | | After study enrollment has been completed; on average 15.8 months after the center had enrolled its first subject | | | | ID | Title | Description |
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| OG000 | Clinicians | Clinicians who responded to the survey |
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| Secondary | In-office Follow-up Burden: Distance Traveled | Subjects' responses to the survey. Subjects were asked to provide the distance (in miles) from their home to the clinic/hospital. | All enrolled subjects who completed some portion of the caregiver burden survey and satisfied the inclusion/exclusion criteria were included. | Posted | | Mean | Standard Deviation | Miles | | 1 month visit | | | | ID | Title | Description |
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| OG000 | Enrolled Subjects | All enrolled subjects who completed some portion of the caregiver burden survey at 1 month visit |
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| Secondary | In-office Follow-up Burden: Patient Expenses | On a survey at the one month visit, the patient estimated their expenses in traveling to that visit. | All enrolled subjects who completed some portion of the caregiver burden survey and satisfied the inclusion/exclusion criteria were included. | Posted | | Mean | Standard Deviation | Dollars | | 1 month | | | | ID | Title | Description |
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| OG000 | Enrolled Subjects | All enrolled subjects who completed some portion of the caregiver burden survey at 1 month visit |
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| Secondary | In-office Follow-up Burden: Hours Absent From Work Due to Visit | Subjects were asked at their one month visit to indicate on a survey how many hours of work they were missing to attend that visit. | All enrolled subjects who completed some portion of the caregiver burden survey and satisfied the inclusion/exclusion criteria were included. | Posted | | Mean | Standard Deviation | Hours | | 1 month | | | | ID | Title | Description |
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| OG000 | Enrolled Subjects | All enrolled subjects who completed some portion of the caregiver burden survey at 1 month visit |
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