Trials / Completed
CompletedNCT01076374
MEDTRONIC ADAPTA, VERSA AND SENSIA nEw3 POST APPROVAL STUDY
Medtronic Adapta/Versa/Sensia Long Term Reliability Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,927 (actual)
- Sponsor
- Medtronic · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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).
Detailed description
The rate of device malfunctions will be determined and a comparison to historical controls will be done.
Conditions
Timeline
- Start date
- 2008-07-01
- Primary completion
- 2015-10-01
- Completion
- 2015-12-01
- First posted
- 2010-02-26
- Last updated
- 2018-04-26
Locations
129 sites across 12 countries: United States, Austria, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Serbia, Sweden, Switzerland
Source: ClinicalTrials.gov record NCT01076374. Inclusion in this directory is not an endorsement.