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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01076374
Recruitment Status : Completed
First Posted : February 26, 2010
Last Update Posted : April 26, 2018
Information provided by (Responsible Party):

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).

Condition or disease
Arrhythmia Bradycardia

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

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Study Type : Observational
Actual Enrollment : 2927 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Medtronic Adapta/Versa/Sensia Long Term Reliability Study
Study Start Date : July 2008
Actual Primary Completion Date : October 2015
Actual Study Completion Date : December 2015

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01076374

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Sponsors and Collaborators
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Study Chair: nEw3 PAS Clinical Trial Leader Medtronic
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Responsible Party: Medtronic Identifier: NCT01076374    
Other Study ID Numbers: nEw3 PAS
First Posted: February 26, 2010    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018
Keywords provided by Medtronic:
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes