MEDTRONIC ADAPTA, VERSA AND SENSIA nEw3 POST APPROVAL STUDY

Arrhythmia Clinical Trial

Official title:

Medtronic Adapta/Versa/Sensia Long Term Reliability Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01076374
• Other study ID #: nEw3 PAS
• Status: Completed
• First received: February 24, 2010
• Last updated: April 24, 2018
• Start date: July 2008
• Est. completion date: December 2015

Study information

• Verified date: April 2018
• Source: Medtronic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2927
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmia
• Bradycardia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of device malfunctions		5 years