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MEDTRONIC ADAPTA, VERSA AND SENSIA nEw3 POST APPROVAL STUDY

NCT01076374 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2927

Last updated 2018-04-26

No results posted yet for this study

Summary

The primary purpose of this study is to assess the long term reliability of the Medtronic Adapta®/Sensia™/Versa™ platform of devices. This study is required by FDA as a condition of approval of nEw3 devices. Patients will be followed for 5 years after implant. This study utilizes data collected from the System Longevity Study (SLS).

Conditions

Sponsors & Collaborators

Principal Investigators

  • nEw3 PAS Clinical Trial Leader · Medtronic

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2015-10-31
Completion
2015-12-31

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • Denmark
  • France
  • Germany
  • Italy
  • Netherlands
  • Serbia
  • Sweden
  • Switzerland

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 NCT01076374 on ClinicalTrials.gov