Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

nEw3 Post-approval Study

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2014 by Medtronic Cardiac Rhythm and Heart Failure.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure Identifier:
First received: February 24, 2010
Last updated: July 25, 2014
Last verified: July 2014
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).


Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Medtronic Adapta/Versa/Sensia Long Term Reliability Study

Further study details as provided by Medtronic Cardiac Rhythm and Heart Failure:

Primary Outcome Measures:
  • Rate of device malfunctions [ Time Frame: 5 years ]

Estimated Enrollment: 336
Study Start Date: July 2008
Estimated Study Completion Date: March 2016
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Detailed Description:
The rate of device malfunctions will be determined and a comparison to historical controls will be done.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects implanted with a Medtronic Adapta®, Sensia™, or Versa™ IPG.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01076374

  Show 129 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Study Chair: nEw3 PAS Clinical Trial Leader Medtronic
  More Information

Responsible Party: Medtronic Cardiac Rhythm and Heart Failure Identifier: NCT01076374     History of Changes
Other Study ID Numbers: nEw3 PAS
Study First Received: February 24, 2010
Last Updated: July 25, 2014

Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on May 25, 2017