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

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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).

The rate of device malfunctions will be determined and a comparison to historical controls
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
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Charleston, South Carolina 29412
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Colorado Springs, Colorado 80910
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Greensboro, North Carolina 27401
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