MEDTRONIC ADAPTA, VERSA AND SENSIA nEw3 POST APPROVAL STUDY

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01076374
• Date of registration: 24/02/2010
• Prospective Registration: No
• Primary sponsor: Medtronic
• Public title: MEDTRONIC ADAPTA, VERSA AND SENSIA nEw3 POST APPROVAL STUDY
• Scientific title: Medtronic Adapta/Versa/Sensia Long Term Reliability Study
• Date of first enrolment: July 2008
• Target sample size: 2927
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01076374
• Study type: Observational

Countries of recruitment

Australia, Austria, Belgium, Canada, Denmark, Former Serbia and Montenegro, France, Germany, Italy, Netherlands, Serbia, Spain, Sweden, Switzerland, United States

Contacts

• Name: nEw3 PAS Clinical Trial Leader
• Affiliation: Medtronic

Key inclusion & exclusion criteria

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



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Bradycardia

Arrhythmia

Primary Outcome(s)

Rate of device malfunctions [Time Frame: 5 years]

Secondary ID(s)

nEw3 PAS

Source(s) of Monetary Support

Please refer to primary and secondary sponsors