Overview

This trial is active, not recruiting.

Conditions arrhythmia, bradycardia
Sponsor Medtronic Cardiac Rhythm Disease Management
Start date July 2008
End date March 2011
Trial size 336 participants
Trial identifier NCT01076374, nEw3 PAS

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Rate of device malfunctions
time frame: 5 years

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Medtronic Adapta/Versa/Sensia Long Term Reliability Study
Description The rate of device malfunctions will be determined and a comparison to historical controls will be done.
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Medtronic Cardiac Rhythm Disease Management.