N/A N=2,101

Advanced Bradycardia Device Feature Utilization and Clinical Outcomes II

Standard Bradycardia Pacing Indication

Bottom Line

View on ClinicalTrials.gov: NCT02577887 ↗

Enrolled (actual)

2,101

Serious AEs

3.3%

Results posted

Nov 2019

Primary outcome: Primary: Percentage of Participants With Complications in the General Pacemaker Population — 3.33 percentage of subjects

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Patients implanted with a St. Jude Medical pacemakers (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Abbott Medical Devices
Primary completion: Nov 2017

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	—

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.

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

View full record on ClinicalTrials.gov →

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.