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The purpose of this study is to characterize the utilization of diagnostics capabilities in St. Jude Medical pacemakers to manage patients with a standard bradycardia pacing indication.
The study is a prospective, non-randomized, multi-center observational study designed to evaluate the utilization of diagnostic capabilities, indications, MRI scanning capabilities and clinical outcomes of patients implanted with SJM pacemakers.
The total duration of the study is expected to be approximately 30 months. The clinical study will be conducted in up to 160 centers across Europe, Middle East, Africa, (EMEA region) and Asia, Australia and New Zealand (Asia-Pac region). Approximately 2016 subjects will be enrolled in this study. Subjects will be followed for 1 year after pacemaker implant.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patients implanted with a St. Jude Medical pacemakers | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complications in the General Pacemaker Population | The rate of device related adverse events that require a medical intervention and/or hospitalization for treatment. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Programmed With Advanced Pacemaker Features | Advanced pacemaker features include Autocapture, Auto sensitivity control (ASC), Ventricular Intrinsic Preference (VIP®), Patient Notifier, RF telemetry, and newer advanced features. | 1 year |
| Number of Pacemaker Patients With Atrial Tachycardia/Fibrillation (AT/AF), Ventricular Tachycardia/Fibrillation (VT/VF), Pacemaker-mediated Tachycardia (PMT) and Automatic Mode Switching (AMS) Episodes |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with a standard bradycardia pacing indication and implanted with a St. Jude Medical pacemaker
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| Name | Affiliation | Role |
|---|---|---|
| Grant Kim | Abbott Medical Devices | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 114 Avenue d'Arès | Bordeaux | 33074 | France | |||
| Kliniken der Friedrich-Alexander-Universität |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Consented Patients | Patients implanted with Accent MRI, Assurity MRI, Endurity MRI or other newer SJM pacemakers, with a standard indication for implant. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All consent patients.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Consented Patients | Patients implanted with Accent MRI, Assurity MRI, Endurity MRI or other newer SJM pacemakers, with a standard indication for implant. |
| 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 | Percentage of Participants With Complications in the General Pacemaker Population | The rate of device related adverse events that require a medical intervention and/or hospitalization for treatment. | All subjects. | Posted | Number | 95% Confidence Interval | percentage of subjects | 1 year |
|
|
1 year
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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 | All Consented Patients | Patients implanted with Accent MRI, Assurity MRI, Endurity MRI or other newer SJM pacemakers, with a standard indication for implant. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Loss of Normal Desired Pacing and/or Sensing due to Lead Displacement | Product Issues | System Organ Class | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma | Vascular disorders | SOC | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Grant Kim | Abbott (previously St Jude Medical) | 818-493-3147 | grant.kim@abbott.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 28, 2015 | Sep 17, 2019 | Prot_SAP_000.pdf |
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At each follow-up, devices were interrogated and device session records were uploaded. Episodes of AT/AF, VT/VF, PMT and AMS were measured by the pacemakers diagnostics features. |
| 1 year |
| Number of MRI Scans by Country | The total number of scans performed by country | 1 year |
| Erlangen |
| 91054 |
| Germany |
| Via Palermo 636 | Catania | 951200 | Italy |
| 2-15 Yamadaoka | Suita | 565-0871 | Japan |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Primary Indication | Count of Participants | Participants |
|
| Cardiovascular History | Count of Participants | Participants |
|
| Medication | Count of Participants | Participants |
|
| Blood Pressure (mm Hg) | Mean | Standard Deviation | mm Hg |
|
| Ejection Fraction (%) | Mean | Standard Deviation | % of blood leaving heart at contraction |
|
| Heart Rate (bpm) | Mean | Standard Deviation | bpm |
|
| Other Medical History | Count of Participants | Participants |
|
| Cardiovascular Interventions | Count of Participants | Participants |
|
|
| Secondary | Number of Subjects Programmed With Advanced Pacemaker Features | Advanced pacemaker features include Autocapture, Auto sensitivity control (ASC), Ventricular Intrinsic Preference (VIP®), Patient Notifier, RF telemetry, and newer advanced features. | All study participants that completed that 12-month visit and had the feature enabled for the duration of the study. Subjects that had a change in the status of the feature (e.g. ON to OFF) are not included in the count shown here. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Number of Pacemaker Patients With Atrial Tachycardia/Fibrillation (AT/AF), Ventricular Tachycardia/Fibrillation (VT/VF), Pacemaker-mediated Tachycardia (PMT) and Automatic Mode Switching (AMS) Episodes | At each follow-up, devices were interrogated and device session records were uploaded. Episodes of AT/AF, VT/VF, PMT and AMS were measured by the pacemakers diagnostics features. | All patients that completed the 12-month follow-up visit. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Number of MRI Scans by Country | The total number of scans performed by country | All study participants | Posted | Number | scans | 1 year |
|
|
|
| 94 |
| 2,101 |
| 70 |
| 2,101 |
| 19 |
| 2,101 |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | System Organ Class | Systematic Assessment |
|
| Unknown Death | General disorders | System Organ Class | Systematic Assessment |
|
| Cardiac Perforation | Injury, poisoning and procedural complications | System Organ Class | Systematic Assessment |
|
| Hematoma | Vascular disorders | System Organ Class | Systematic Assessment |
|
| Lead Malfunction | Product Issues | System Organ Class | Systematic Assessment | Fracture or damage to insulation |
|
| Arrhythmia | Cardiac disorders | System Organ Class | Systematic Assessment |
|
| Cardiac Arrest | Cardiac disorders | System Organ Class | Systematic Assessment |
|
| Cardiac Tamponade | Cardiac disorders | System Organ Class | Systematic Assessment |
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| Endocarditis | Cardiac disorders | System Organ Class | Systematic Assessment |
|
| Pacemaker Mediated Tachycardia | Product Issues | System Organ Class | Systematic Assessment |
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| TIA | Nervous system disorders | System Organ Class | Systematic Assessment |
|
| Device Migration | Injury, poisoning and procedural complications | System Organ Class | Systematic Assessment |
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| Infection | Infections and infestations | System Organ Class | Systematic Assessment |
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| Inflammatory Allergic Reaction | Immune system disorders | System Organ Class | Systematic Assessment |
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| Lead Misplacement | Injury, poisoning and procedural complications | System Organ Class | Systematic Assessment |
|
| Loss of Normal Device Function due to Battery Failure or Component Malfunction | Product Issues | System Organ Class | Systematic Assessment |
|
| Pericarditis associated with Dressler's Syndrome | Cardiac disorders | System Organ Class | Systematic Assessment |
|
| Pocket Erosion | Injury, poisoning and procedural complications | System Organ Class | Systematic Assessment |
|
| Reduction of LVEF due to RV Pacing | Investigations | System Organ Class | Systematic Assessment |
|
| Stroke | Nervous system disorders | System Organ Class | Systematic Assessment |
|
| Threshold Elevation | Product Issues | System Organ Class | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | System Organ Class | Systematic Assessment |
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| Lead Noise | Product Issues | System Organ Class | Systematic Assessment |
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| Threshold Elevation | Product Issues | System Organ Class | Systematic Assessment |
|
| Extracardiac Stimulation | Product Issues | System Organ Class | Systematic Assessment |
|
| Pacemaker Mediated Tachycardia | Product Issues | System Organ Class | Systematic Assessment |
|
| Pain at IPG Site | General disorders | System Organ Class | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | System Organ Class | Systematic Assessment |
|
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| Trigger Alert: High RV Rate |
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| Trigger Alert: High V Rate during AT/AF |
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| Trigger Alert: AT/AF |
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| Trigger Alert: Exceeded AT/AF Burden |
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| Trigger Alert: % V Pace |
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| Trigger Alert: Atrial Impedance Out of Range |
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| Trigger Alert: Ventricular Impedance Out of Range |
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| Remote Monitoring |
|
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| Atrial Capture Confirm |
|
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| Right Ventricular Auto Capture |
|
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| Atrial Pace during PMT |
|
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| Title | Measurements |
|---|---|
|
| Japan |
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| France |
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| Belgium |
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| Austria |
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| Netherland |
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| Spain |
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| South Korea |
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| Finland |
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| UK |
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| Portugal |
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