Optisure Lead Post Approval Study

NCT02235545 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 1735

Last updated 2025-07-30

Study results available
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Summary

The purpose of this post approval study is to characterize the chronic performance of the SJM Optisure family of HV leads in patients.

Conditions

Interventions

DEVICE

St. Jude Medical Optisure Lead

Patients implanted with St. Jude Medical Optisure Lead

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Nicole Harbert · Abbott

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2019-12-16
Completion
2020-06-30
FDA Device
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Germany
  • Japan
  • Poland
  • Portugal

Study Locations

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Entities

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 NCT02235545 on ClinicalTrials.gov