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

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2015/12/006400
• Date of registration: 01-12-2015
• Prospective Registration: No
• Primary sponsor: St Jude Medical Pvt Ltd
• Public title: Data collection in patients implanted with pacemaker to characterize the complication rate in the pacemaker patient population
• Scientific title: Advanced BRADYCARdia Device Feature Utilization and Clinical OutcomEs II - Bradycare II
• Date of first enrolment: 10-10-2015
• Target sample size: 2016
• Recruitment status: Open to Recruitment
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=12467
• Study type: Observational
• Study design: Single Arm Trial; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
• Phase: N/A

Countries of recruitment

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

Contacts

• Name: Sumit Anand
• Affiliation: St. Jude Medical India Pvt. Ltd

• Name: Sumit Anand
• Affiliation: St. Jude Medical India Pvt. Ltd

Key inclusion & exclusion 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: Patientâ??s whose life expectancy is less than 1 year

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- bradycardia pacing indication

Intervention(s)

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?¢ or other SJM MRI compatible pacemakers.

Primary Outcome(s)

Complication rate at 1 year post implant in general pacemaker population

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

Secondary Outcome(s)

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

Secondary ID(s)

SJM-CIP-10073

Source(s) of Monetary Support

St. Jude Medical Pvt. Ltd.

Ethics review

Status: Approved
Approval date: 05/09/2015
Contact:

KIMS Foundation & Research Center Ethics Committee

Status: Approved
Approval date: 14/09/2015
Contact:

Institutional Ethics Committee,Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute

Status: Approved
Approval date: 28/10/2015
Contact:

Medanta Institutional Ethics Committee