Standard Bradycardia Pacing Indication
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPatients implanted with a St. Jude Medical pacemakers
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who have been implanted with an SJM Assurity MRI™, Endurity MRI™ or other SJM MRI compatible pacemakers in the EMEA region within 30 days or patients implanted with an Accent MRI™, Assurity MRI™, Endurity MRI™ or other SJM MRI compatible pacemakers in the Asia-Pac region within 30 days. * Patient is geographically stable and willing to comply with the required follow-up schedule. * Patient is not pregnant or planning to become pregnant during the course of the study. * Patient is \> 18 years of age
Exclusion criteria
* Patient's life expectancy is less than 1 year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Complications in the General Pacemaker Population | 1 year | The rate of device related adverse events that require a medical intervention and/or hospitalization for treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Programmed With Advanced Pacemaker Features | 1 year | Advanced pacemaker features include Autocapture, Auto sensitivity control (ASC), Ventricular Intrinsic Preference (VIP®), Patient Notifier, RF telemetry, and newer advanced features. |
| 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 | 1 year | 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. |
| Number of MRI Scans by Country | 1 year | The total number of scans performed by country |
Countries
France, Germany, Italy, Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Consented Patients Patients implanted with Accent MRI, Assurity MRI, Endurity MRI or other newer SJM pacemakers, with a standard indication for implant. | 2,101 |
| Total | 2,101 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 93 |
| Overall Study | Protocol Violation | 125 |
| Overall Study | Withdrawal by Subject | 80 |
Baseline characteristics
| Characteristic | All Consented Patients | — |
|---|---|---|
| Age, Continuous | 74.5 years STANDARD_DEVIATION 10.6 | — |
| Blood Pressure (mm Hg) Diastolic Blood Pressure | 74.8 mm Hg STANDARD_DEVIATION 12.2 | — |
| Blood Pressure (mm Hg) Systolic Blood Pressure | 138.3 mm Hg STANDARD_DEVIATION 21.9 | — |
| Cardiovascular History Angina | 62 Participants | — |
| Cardiovascular History Cardiomyopathy | 438 Participants | — |
| Cardiovascular History Coronary Artery Disease | 452 Participants | — |
| Cardiovascular History Heart Failure | 4 Participants | — |
| Cardiovascular History Hypertension | 1371 Participants | — |
| Cardiovascular History Myocardial infarction | 182 Participants | — |
| Cardiovascular Interventions Ablation | 3 Participants | — |
| Cardiovascular Interventions Coronary Artery Bypass Grafting (CABG) | 113 Participants | — |
| Cardiovascular Interventions Perc Coronary Intervention (PCI )/ Atherectomy | 251 Participants | — |
| Ejection Fraction (%) | 59.6 % of blood leaving heart at contraction STANDARD_DEVIATION 9.4 | — |
| Heart Rate (bpm) | 64.2 bpm STANDARD_DEVIATION 16.4 | — |
| Medication ACE Inhibitors/ ARBs | 1124 Participants | — |
| Medication Aldosterone Inhibitors | 85 Participants | — |
| Medication Antiarrhythmics- Class I | 82 Participants | — |
| Medication Antiarrhythmics- Class III | 98 Participants | — |
| Medication Anti-Coagulants | 679 Participants | — |
| Medication Antiplatelet | 665 Participants | — |
| Medication Beta Blockers | 711 Participants | — |
| Medication Calcium Channel Blockers | 612 Participants | — |
| Medication Cardiac Glycosides | 46 Participants | — |
| Medication Diuretics | 730 Participants | — |
| Medication Nitrates | 109 Participants | — |
| Medication Other Cardiac | 96 Participants | — |
| Medication Positive Inotropics | 3 Participants | — |
| Medication Statins | 154 Participants | — |
| Other Medical History Diabetes | 509 Participants | — |
| Other Medical History Heaptic/Renal disease | 253 Participants | — |
| Other Medical History Peripheral vascular disease | 90 Participants | — |
| Other Medical History Pulmonary disease | 89 Participants | — |
| Other Medical History Smoking | 634 Participants | — |
| Other Medical History Stroke | 216 Participants | — |
| Primary Indication AV Node Block | 1026 Participants | — |
| Primary Indication Pacemaker replacement | 2 Participants | — |
| Primary Indication Prevention/Termination of Tachyarrhythmias by Paci | 16 Participants | — |
| Primary Indication Sinus Node Dysfunction | 868 Participants | — |
| Primary Indication Syncope | 189 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Austria | 96 Participants | — |
| Region of Enrollment Belgium | 64 Participants | — |
| Region of Enrollment China | 48 Participants | — |
| Region of Enrollment Estonia | 183 Participants | — |
| Region of Enrollment Finland | 92 Participants | — |
| Region of Enrollment France | 241 Participants | — |
| Region of Enrollment Germany | 236 Participants | — |
| Region of Enrollment Hong Kong | 10 Participants | — |
| Region of Enrollment India | 56 Participants | — |
| Region of Enrollment Italy | 178 Participants | — |
| Region of Enrollment Japan | 234 Participants | — |
| Region of Enrollment Lithuania | 46 Participants | — |
| Region of Enrollment Netherlands | 131 Participants | — |
| Region of Enrollment Portugal | 102 Participants | — |
| Region of Enrollment South Korea | 155 Participants | — |
| Region of Enrollment Spain | 157 Participants | — |
| Region of Enrollment United Kingdom | 72 Participants | — |
| Sex: Female, Male Female | 896 Participants | — |
| Sex: Female, Male Male | 1205 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 94 / 2,101 |
| other Total, other adverse events | 19 / 2,101 |
| serious Total, serious adverse events | 70 / 2,101 |
Outcome results
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.
Time frame: 1 year
Population: All subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Consented Patients | Percentage of Participants With Complications in the General Pacemaker Population | 3.33 percentage of subjects |
Secondary
Number of MRI Scans by Country
The total number of scans performed by country
Time frame: 1 year
Population: All study participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Consented Patients | Number of MRI Scans by Country | Estonia | 34 scans |
| All Consented Patients | Number of MRI Scans by Country | Japan | 13 scans |
| All Consented Patients | Number of MRI Scans by Country | Italy | 14 scans |
| All Consented Patients | Number of MRI Scans by Country | Germany | 13 scans |
| All Consented Patients | Number of MRI Scans by Country | France | 10 scans |
| All Consented Patients | Number of MRI Scans by Country | Belgium | 7 scans |
| All Consented Patients | Number of MRI Scans by Country | Austria | 6 scans |
| All Consented Patients | Number of MRI Scans by Country | Netherland | 5 scans |
| All Consented Patients | Number of MRI Scans by Country | Spain | 4 scans |
| All Consented Patients | Number of MRI Scans by Country | South Korea | 4 scans |
| All Consented Patients | Number of MRI Scans by Country | Finland | 2 scans |
| All Consented Patients | Number of MRI Scans by Country | UK | 2 scans |
| All Consented Patients | Number of MRI Scans by Country | Portugal | 2 scans |
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.
Time frame: 1 year
Population: All patients that completed the 12-month follow-up visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Consented Patients | 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 | Number of subjects with AT/AF | 427 Participants |
| All Consented Patients | 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 | Number of subjects with PMT | 563 Participants |
| All Consented Patients | 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 | Number of subjects with VT/VF | 861 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.
Time frame: 1 year
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Consented Patients | Number of Subjects Programmed With Advanced Pacemaker Features | Ventricular Intrinsic Preference | 732 Participants |
| All Consented Patients | Number of Subjects Programmed With Advanced Pacemaker Features | AF Suppression | 10 Participants |
| All Consented Patients | Number of Subjects Programmed With Advanced Pacemaker Features | Trigger Alert: High RV Rate | 1738 Participants |
| All Consented Patients | Number of Subjects Programmed With Advanced Pacemaker Features | Trigger Alert: High V Rate during AT/AF | 1439 Participants |
| All Consented Patients | Number of Subjects Programmed With Advanced Pacemaker Features | Trigger Alert: AT/AF | 1432 Participants |
| All Consented Patients | Number of Subjects Programmed With Advanced Pacemaker Features | Trigger Alert: Exceeded AT/AF Burden | 1433 Participants |
| All Consented Patients | Number of Subjects Programmed With Advanced Pacemaker Features | Trigger Alert: % V Pace | 1280 Participants |
| All Consented Patients | Number of Subjects Programmed With Advanced Pacemaker Features | Trigger Alert: Atrial Impedance Out of Range | 34 Participants |
| All Consented Patients | Number of Subjects Programmed With Advanced Pacemaker Features | Trigger Alert: Ventricular Impedance Out of Range | 37 Participants |
| All Consented Patients | Number of Subjects Programmed With Advanced Pacemaker Features | Remote Monitoring | 198 Participants |
| All Consented Patients | Number of Subjects Programmed With Advanced Pacemaker Features | Atrial Capture Confirm | 245 Participants |
| All Consented Patients | Number of Subjects Programmed With Advanced Pacemaker Features | Right Ventricular Auto Capture | 678 Participants |
| All Consented Patients | Number of Subjects Programmed With Advanced Pacemaker Features | Atrial Pace during PMT | 1412 Participants |