MEDTRONIC ADAPTA, VERSA AND SENSIA nEw3 POST APPROVAL STUDY

Completed

Conditions studied: Arrhythmia, Bradycardia

In brief

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).

Key facts

Study ID

NCT01076374

Run by

Medtronic

People needed

2927

Starts

2008-07-01

Expected to finish

2015-12-01

Last updated by the study team

2018-04-26

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Study site — Anchorage, Alaska, United States
• Study site — Gilbert, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Jonesboro, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Bakersfield, California, United States
• Study site — Chula Vista, California, United States
• Study site — Downey, California, United States
• Study site — East Palo Alto, California, United States
• Study site — La Jolla, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Redding, California, United States
• Study site — Salinas, California, United States
• Study site — San Diego, California, United States
• Study site — Santa Rosa, California, United States
• Study site — Torrance, California, United States
• Study site — Van Nuys, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — Newark, Delaware, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Bradenton, Florida, United States
• Study site — Clearwater, Florida, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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