HVP_MDT1987434 - Medtronic Surveillance

Product Surveillance Registry Base Protocol

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.

Key Inclusion Criteria:

1. Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements.
2. Patient has or is intended to receive or be treated with an eligible Medtronic product.
3. Patient within enrollment window relative to therapy initiation or meets criteria for retrospective enrollment.

See clinicaltrials.gov for full details.
Heart and Vascular
Ashkan Babaie, M.D.
Gerald Leonard
  • Providence Portland Medical Center
  • Providence St. Vincent Medical Center