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SJM Brady MRI Post Approval Study

NCT03170583 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 1768

Last updated 2020-07-28

No results posted yet for this study

Summary

The purpose of this post approval study is to evaluate the long-term safety of the FDA approved St. Jude Medical Tendril MRI™ lead implanted with a SJM Brady MRI implantable pulse generator (IPG) such as the Accent MRI™, Assurity MRI™, Endurity MRI™ pacemaker, or similar model (SJM Brady MRI System) in subjects with a standard bradycardia pacing indication.

Conditions

  • Bradycardia

Interventions

DEVICE

St. Jude Medical Tendril MRI™ lead

pacemaker, leads

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Grant Kim, MS · Abbott (formerly St. Jude Medical)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-08
Primary Completion
2020-06-30
Completion
2020-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03170583 on ClinicalTrials.gov