Pacemaker
Conditions
Keywords
Pacemaker, Advanced Features, Clinical Outcomes
Brief summary
Pacemaker technology is constantly evolving. In the past 10 years, numerous advancements have been made in pacemaker therapy, diagnostics and connectivity. These advancements include automated capture, automated sensing, patient alert functions, algorithms minimizing ventricular pacing, automatic mode switching in response to atrial tachyarrhythmia, rate responsive pacing, advanced diagnostic features, remote monitoring and radiofrequency (RF) technology. However, little information is available on how these new features are being utilized by physicians in the real world and how these features impact patient outcomes. This observational study will gather data on the patients' presenting clinical status, indication for device implantation, utilization of advanced device features, device therapy choices, clinical management and outcomes in a general pacemaker population. The primary aim of the study is to evaluate the usage of advanced features and diagnostics in patients with St. Jude Medical pacemakers. The secondary aim of the study is to learn more about the progressive clinical outcomes in the general pacemaker patient population. The tertiary aim of the study is to evaluate the correlation between the usage of advanced features in pacemaker patients and the patient's clinical outcomes.
Detailed description
Evaluation of Device Features and Diagnostics * Programmed parameters: Advanced pacemaker features (Autocapture, Auto sensitivity control (ASC), Ventricular Intrinsic Preference (VIP®), Patient Notifier, RF telemetry, and newer advanced features) * Device and lead measurements * Number of AT/AF, VT/VF, PMT and AMS episodes Evaluation of Clinical Parameters * Indication for device implantation * Cardiac and arrhythmia history * Cardiac drug utilization * Cardiac events: incidence and onset of symptomatic atrial fibrillation (AF), onset of heart failure (HF), incidence and onset of angina, occurrence of myocardial infarction (MI), occurrence of transient ischemic attack (TIA)/ischemic stroke, and occurrence of hemorrhagic stroke * Modified Specific Activity Scale (SAS) * Intrinsic QRS duration * Left ventricular ejection fraction (LVEF) * Adverse events * All-cause, cardiovascular and heart failure hospitalizations * All-cause, cardiovascular and heart failure mortality
Interventions
None listed
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient has a current indication for a single-chamber (SR) or dual-chamber (DR) pacemaker or CRT-P device. * Patient is implanted with an SJM Accent™ SR/DR, Accent™ SR/DR RF, Anthem™ CRT-P, Anthem™ CRT-P RF, or newer SJM pacemaker device. * Patient is geographically stable and willing to comply with the required follow-up schedule. * Patient is not pregnant or planning to become pregnant. * Patient is \>18 years of age.
Exclusion criteria
* Patient's life expectancy is less than 12 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complication Rate at 1-year Post-implant | 12 months | Complication rate and 95% confidence interval at 1-year post-implant |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Subjects Enrolled in the Study All subjects that were enrolled in the study. | 3,389 |
| Total | 3,389 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | All Withdrawals | 324 |
| Overall Study | Death | 209 |
Baseline characteristics
| Characteristic | All Subjects Enrolled in the Study |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2830 Participants |
| Age, Categorical Between 18 and 65 years | 559 Participants |
| Age, Continuous | 74.8 years STANDARD_DEVIATION 11.1 |
| Cardiovascular History Angina | 156 Participants |
| Cardiovascular History Coronary Artery Disease | 1361 Participants |
| Cardiovascular History Heart Failure | 25 Participants |
| Cardiovascular History Hypertension | 2668 Participants |
| Cardiovascular History Myocardial Infarction | 204 Participants |
| Diastolic BP | 72.2 mm Hg STANDARD_DEVIATION 11.3 |
| Ejection Fraction | 56.8 % of blood leaving heart at contraction STANDARD_DEVIATION 9.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 185 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3175 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 29 Participants |
| Heart Rate | 69.4 beats per min (bpm) STANDARD_DEVIATION 12.1 |
| Medications ACE Inhibitors/ARBs | 1659 Participants |
| Medications Aldosterone inhibitors | 64 Participants |
| Medications Antiarrhythmics - Class I | 103 Participants |
| Medications Antiarrhythmics - Class III | 356 Participants |
| Medications Anti-coagulants | 1064 Participants |
| Medications Antiplatelet | 1833 Participants |
| Medications Beta Blockers | 1653 Participants |
| Medications Calcium channel blockers | 936 Participants |
| Medications Cardiac glycosides | 239 Participants |
| Medications Diuretics | 1172 Participants |
| Medications Nitrates | 360 Participants |
| Medications Other cardiac | 351 Participants |
| Medications Positive Ionotropics | 11 Participants |
| Medications Statins | 150 Participants |
| Other Medical History Diabetes | 869 Participants |
| Other Medical History Hepatic/Renal disease | 306 Participants |
| Other Medical History Peripheral vascular disease | 240 Participants |
| Other Medical History Pulmonary disease | 335 Participants |
| Primary Indication for Pacemaker Implant AV Node Block | 754 Participants |
| Primary Indication for Pacemaker Implant Others | 20 Participants |
| Primary Indication for Pacemaker Implant Pacemaker Replacement | 329 Participants |
| Primary Indication for Pacemaker Implant PAVE | 55 Participants |
| Primary Indication for Pacemaker Implant Sinus Node Dysfunction | 2427 Participants |
| Primary Indication for Pacemaker Implant Syncope | 220 Participants |
| Region of Enrollment United States | 3389 participants |
| Sex: Female, Male Female | 1546 Participants |
| Sex: Female, Male Male | 1843 Participants |
| Systolic BP | 130.1 mm Hg STANDARD_DEVIATION 19.6 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 209 / 3,389 |
| other Total, other adverse events | 17 / 3,389 |
| serious Total, serious adverse events | 38 / 3,389 |
Outcome results
Primary
Complication Rate at 1-year Post-implant
Complication rate and 95% confidence interval at 1-year post-implant
Time frame: 12 months
Population: All subjects enrolled in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects Enrolled in the Study | Complication Rate at 1-year Post-implant | 1.12 percentage of enrolled subjects |