Skip to main content
OpenTrials
Completed

NCT Number: NCT01076374

MEDTRONIC ADAPTA, VERSA AND SENSIA nEw3 POST APPROVAL 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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Arrhythmia Arrhythmias, Cardiac Bradycardia Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Linz, Austria

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Rate of device malfunctions

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Medtronic

Industry

Registry information

Official study title

Medtronic Adapta/Versa/Sensia Long Term Reliability Study

Important dates

Study start
2008
Primary completion
2015
Study completion
2015
First posted
Feb 26, 2010
Registry last updated
Apr 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.