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Data collection in patients implanted with pacemaker to characterize the complication rate in the pacemaker patient population

Advanced BRADYCARdia Device Feature Utilization and Clinical OutcomEs II - Bradycare II

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2015/12/006400
Enrollment
2016
Registered
2015-12-01
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- bradycardia pacing indication

Interventions

Intervention1: Market approved St.Jude Medical Accent MRI, Assurity MRI, Endurity MRI or similar model in the Asia-Pac region.: Patients implanted with an Accent MRIâ?¢, Assurity MRIâ?¢, Endurity MRIâ

Sponsors

St Jude Medical Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients who have been implanted with an Accent MRI•, Assurity MRI•, Endurity MRI• or other SJM MRI compatible pacemakers 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

Exclusion criteria: Patientâ??s whose life expectancy is less than 1 year

Design outcomes

Primary

MeasureTime frame
Complication rate at 1 year post implant in general pacemaker population Timepoint: Complication rate at 1 year post implant in general pacemaker population

Secondary

MeasureTime frame
Effect of the usage of advanced features in pacemaker on the clinical outcomes Number and proportion of MRI scans received in pacemaker patients by country Timepoint: 1 year

Countries

Australia, Austria, Belgium, China, Denmark, Estonia, France, India, Ireland, Italy, Japan, Lithuania, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom

Contacts

Public ContactSumit Anand

St. Jude Medical India Pvt. Ltd

sanand@sjm.com91-8860661364

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026