Cardiac Rhythm Disorders, Urological Disorders, Neurological Disorders, Cardiovascular Disorders, Digestive Disorders, Intracranial Aneurysm, Mechanical Circulatory Support, Respiratory Therapy, Aortic, Peripheral Vascular and Venous Disorders (WIRB-19-0018)

Baptist Health Louisville

John M Mandrola

Principal Investigator

Karin Cryan

Overview

Medtronic Product Surveillance Registry (PSR)

Description

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.

Learn more at clinicaltrials.gov

Eligibility Criteria

Inclusion

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

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