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DF4 Connector System Post-Approval Study

NCT01638897 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1778

Last updated 2019-03-20

No results posted yet for this study

Summary

The purpose of this study is to evaluate long-term performance of the DF4 Connector System. This evaluation is based on the number of DF4 lead-related complications occurring during the study compared to the number of leads enrolled in the study. The DF4 systems will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the DF4 Connector Systems. This study is conducted within Medtronic's post-market surveillance platform.

Conditions

Sponsors & Collaborators

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2019-03-31
Completion
2019-03-31

Countries

  • United States
  • Canada
  • France

Study Locations

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Entities

Diseases
Companies

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 NCT01638897 on ClinicalTrials.gov