N/A
Completed N=3,389
BRADYCARE: Advanced Bradycardia Device Feature Utilization and Clinical Outcomes
Pacemaker
Source: ClinicalTrials.gov NCT01062126 ↗
Enrolled (actual)
3,389
Serious AEs
1.1%
Results posted
Oct 2020
Primary outcomePrimary: Complication Rate at 1-year Post-implant — 1.12 percentage of enrolled subjects
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complication Rate at 1-year Post-implant |
1.12 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01062126). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.