N/A
Completed N=2,101
Advanced Bradycardia Device Feature Utilization and Clinical Outcomes II
Standard Bradycardia Pacing Indication
Source: ClinicalTrials.gov NCT02577887 ↗
Enrolled (actual)
2,101
Serious AEs
3.3%
Results posted
Nov 2019
Primary outcomePrimary: Percentage of Participants With Complications in the General Pacemaker Population — 3.33 percentage of subjects
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Complications in the General Pacemaker Population |
3.33 | — |
| SECONDARY Number of Subjects Programmed With Advanced Pacemaker Features |
732; 10; 1738; 1439; 1432; 1433 | — |
| 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 |
563; 427; 861 | — |
| SECONDARY Number of MRI Scans by Country |
34; 14; 13; 13; 10; 7 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02577887). 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.