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Model 4196 Left Ventricular (LV) Lead Chronic Performance Study

NCT00930904 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1847

Last updated 2017-12-27

No results posted yet for this study

Summary

The purpose of this study is to evaluate long-term performance of the 4196 LV Lead. This evaluation is based on the number of lead-related complications occurring during the study compared to the number of leads enrolled in the study. The leads will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the Model 4196 LV Lead and is integrated within the Product Surveillance Registry (PAN Registry).

Conditions

Sponsors & Collaborators

Principal Investigators

  • 4196 LV Lead Chronic Performance Study Team · Medtronic

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2017-04-30
Completion
2017-04-30

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • France
  • Italy
  • Netherlands
  • Spain

Study Locations

More Related Trials

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 NCT00930904 on ClinicalTrials.gov