nEw3 Post-approval Study

This study is currently recruiting participants.
Verified June 2013 by Medtronic Cardiac Rhythm Disease Management
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT01076374
First received: February 24, 2010
Last updated: June 27, 2013
Last verified: June 2013
  Purpose

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 part of the Product Performance Platform (PPP).


Condition
Arrhythmia
Bradycardia

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

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • Rate of device malfunctions [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 336
Study Start Date: July 2008
Estimated Study Completion Date: October 2014
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects implanted with a Medtronic Adapta®, Sensia™, or Versa™ IPG.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01076374

Contacts
Contact: nEw3 PAS Clinical Trial Leader medtronicCRMtrials@medtronic.com

  Show 129 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Investigators
Study Chair: nEw3 PAS Clinical Trial Leader Medtronic
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT01076374     History of Changes
Other Study ID Numbers: nEw3 PAS
Study First Received: February 24, 2010
Last Updated: June 27, 2013
Health Authority: United States: Institutional Review Board
Canada: Ethics Review Committee
Australia: Human Research Ethics Committee
France: Conseil National de l'Ordre des Médecins
Germany: Federal Institute for Drugs and Medical Devices
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Serbia: Ethics Committee
Austria: Ethikkommission
Denmark: Ethics Committee
Switzerland: Swissmedic
Switzerland: Ethikkommission
Sweden: Regional Ethical Review Board
Italy: Ethics Committee

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
pacemaker

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Bradycardia
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 14, 2014