MEDTRONIC ADAPTA, VERSA AND SENSIA nEw3 POST APPROVAL STUDY

Status Completed

Clinical Trial 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).

Clinical Trial Description

The rate of device malfunctions will be determined and a comparison to historical controls will be done. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01076374
Study type	Observational
Source	Medtronic
Contact
Status	Completed
Phase
Start date	July 2008
Completion date	December 2015

View Details

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