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Model 4195 Left Ventricular (LV) Lead Chronic Performance Study

NCT00869921 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1322

Last updated 2018-09-13

No results posted yet for this study

Summary

Evaluate long-term performance of the 4195 LV Lead. This evaluation is based on the number of lead-related complications occuring 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 4195 LV Lead and is integrated within Medtronic's post-market surveillance platform.

Conditions

Sponsors & Collaborators

Principal Investigators

  • 4195 LV Lead Chronic Performance Study Team · Medtronic

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2018-04-03
Completion
2018-04-03

Countries

  • United States
  • Canada
  • United Kingdom

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 NCT00869921 on ClinicalTrials.gov