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Product Surveillance Registry
Product Surveillance Registry

NCT01524276

RecruitingN/A

Sponsor: Medtronic

Conditions: Cardiac Rhythm Disorders, Urological Disorders, Neurological Disorders, Cardiovascular Disorders, Digestive Disorders

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, China

The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.

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 eligible Medtronic product
* Patient within enrollment window relative to therapy initiation or meets criteria for retrospective enrollment

Exclusion Criteria:

* Patient who is, or will be, inaccessible for follow-up
* Patient with exclusion criteria required by local law
* Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
Locations (400)
  • Birmingham, Alabama, United States
  • Huntsville, Alabama, United States
  • Chandler, Arizona, United States
  • Phoenix, Arizona, United States
  • Little Rock, Arkansas, United States
  • Aliso Viejo, California, United States
  • Chula Vista, California, United States
  • Colton, California, United States
  • La Jolla, California, United States
  • Los Angeles, California, United States
  • Napa, California, United States
  • Redwood City, California, United States
  • Salinas, California, United States
  • San Diego, California, United States
  • Stanford, California, United States
  • Torrance, California, United States
  • Ventura, California, United States
  • Aurora, Colorado, United States
  • Colorado Springs, Colorado, United States
  • Lakewood, Colorado, United States
  • Darien, Connecticut, United States
  • Hartford, Connecticut, United States
  • New Haven, Connecticut, United States
  • Washington D.C., District of Columbia, United States
  • Bradenton, Florida, United States
  • Clearwater, Florida, United States
  • Davie, Florida, United States
  • Jacksonville, Florida, United States
  • Naples, Florida, United States
  • Panama City, Florida, United States
  • + 370 more on CT.gov