MEDTRONIC ADAPTA, VERSA AND SENSIA nEw3 POST APPROVAL STUDY

Medtronic Adapta/Versa/Sensia Long Term Reliability Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01076374

Enrollment

2927

Registered

2010-02-26

Start date

2008-07-31

Completion date

2015-12-31

Last updated

2018-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmia, Bradycardia

Keywords

pacemaker

Brief 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).

Detailed description

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Rate of device malfunctions	5 years

Countries

Austria, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Serbia, Sweden, Switzerland, United States

Outcome results