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Safety and Efficacy Study of Tendril MRI™ Leads in Standard Bradycardia Pacing Indication

NCT01528150 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 466

Last updated 2019-02-04

Study results available
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Summary

The purpose of this observational study is the assessment (safety and efficacy) of the St. Jude Medical Tendril MRI™ leads. The Tendril MRI™ leads are a full part of the Accent MRI™ System, consisting of Tendril MRI™ leads and Accent MRI™ pacemaker. The subject population includes patients with a standard bradycardia pacing indication.

Conditions

  • Bradycardia

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Rob RW Breedveld, MD · Medical Center Leeuwarden, the Netherlands

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2014-06-30
Completion
2015-03-31

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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 NCT01528150 on ClinicalTrials.gov