Data collection in patients implanted with pacemaker to characterize the complication rate in the pacemaker patient populatio
Not Applicable
- Conditions
- Health Condition 1: null- bradycardia pacing indication
- Registration Number
- CTRI/2015/12/006400
- Lead Sponsor
- St Jude Medical Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 2016
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
Patientâ??s whose life expectancy is less than 1 year
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complication rate at 1 year post implant in general pacemaker population <br/ ><br>Timepoint: Complication rate at 1 year post implant in general pacemaker population <br/ ><br>
- Secondary Outcome Measures
Name Time Method Effect of the usage of advanced features in pacemaker on the clinical outcomes <br/ ><br>Number and proportion of MRI scans received in pacemaker patients by country <br/ ><br>Timepoint: 1 year