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Lead Evaluation for Defibrillation and Reliability Post Approval Study
Lead Evaluation for Defibrillation and Reliability Post Approval Study

NCT07005232

Enrolling By InvitationN/A

Sponsor: Medtronic

Conditions: Tachyarrhythmia

Interventions: defibrillation lead

Countries: United States, Austria, Canada, France, Germany, Spain, United Kingdom

Medtronic is sponsoring the LEADR PAS to provide continuing evaluation and periodic reporting of safety and effectiveness of the OmniaSecure™ defibrillation lead following commercial release. The LEADR PAS is conducted within Medtronic's Product Surveillance Registry Platform (NCT01524276).

Eligibility overview

Sex: ALL

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
Inclusion Criteria:

* Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
* Patient has, or is intended to receive or be treated with an OmniaSecure™ defibrillation lead.
* Patient is consented prior to or within 30 days of the therapy received or consented as continuation from the LEADR Pivotal study

Exclusion Criteria:

* Patient who is, or is expected to be, inaccessible for follow-up
* Patient is excluded by local local law
* Patient is currently enrolled or plans to enroll in any concurrent drug and/or device study that may confound the Product Surveillence Registyr (PSR) results
Locations (73)
  • Birmingham, Alabama, United States
  • Stanford, California, United States
  • Torrance, California, United States
  • Aurora, Colorado, United States
  • Hartford, Connecticut, United States
  • Washington D.C., District of Columbia, United States
  • Hollywood, Florida, United States
  • Panama City, Florida, United States
  • Safety Harbor, Florida, United States
  • Sarasota, Florida, United States
  • Tampa, Florida, United States
  • Marietta, Georgia, United States
  • Newburgh, Indiana, United States
  • West Des Moines, Iowa, United States
  • Kansas City, Kansas, United States
  • Edgewood, Kentucky, United States
  • Louisville, Kentucky, United States
  • Lansing, Michigan, United States
  • Ypsilanti, Michigan, United States
  • Coon Rapids, Minnesota, United States
  • Minneapolis, Minnesota, United States
  • Minneapolis, Minnesota, United States
  • Robbinsdale, Minnesota, United States
  • Rochester, Minnesota, United States
  • Columbia, Missouri, United States
  • Kansas City, Missouri, United States
  • St Louis, Missouri, United States
  • Omaha, Nebraska, United States
  • Marlton, New Jersey, United States
  • Albuquerque, New Mexico, United States
  • + 43 more on CT.gov