MEDTRONIC ADAPTA, VERSA AND SENSIA nEw3 POST APPROVAL STUDY
Status: | Completed |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | Any |
Updated: | 4/28/2018 |
Start Date: | July 2008 |
End Date: | December 2015 |
Medtronic Adapta/Versa/Sensia Long Term Reliability Study
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).
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).
The rate of device malfunctions will be determined and a comparison to historical controls
will be done.
will be done.
Inclusion Criteria:
- Subjects or appropriate legal guardians provide written informed consent and/or
authorization for access to and use of health information, as required by an
institution's IRB/MEC/REB.
AND one of the following must also apply:
- Subjects indicated for implant or within six months post-implant of a Medtronic
market-released lead connected to a Medtronic Adapta®, Sensia™, or Versa™ IPG. The
Medtronic lead must be used for pacing, sensing or defibrillation application.
- Subjects who participated in a qualifying study (IDE) of a Medtronic cardiac therapy
product and: 1) have a Medtronic Adapta®, Sensia™, or Versa™ IPG 2)product is
market-released 3) complete implant and follow-up data, including product-related
adverse events are available and 4) subject of appropriate legal guardian authorizes
release of subject study data to SLS
- Subjects implanted with a Medtronic Adapta®, Sensia™, or Versa™ IPG and Medtronic
CapSure Epi Leads (model 4965 and 4968) at a minimum of three pre-selected sites to
retrospectively collect data for post approval requirements.
Exclusion Criteria:
- Subjects who are, or will be inaccessible for follow-up at a SLS center
- Subjects with exclusion criteria required by local law (EMEA only)
- Subjects receiving an implant of a Medtronic device at a non-participating center and
the implant data and current status cannot be confirmed within 30 days after implant
- Subjects implanted with a Medtronic device whose predetermined enrollment limit for
that specific product has been exceeded
We found this trial at
111
sites
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