Product Surveillance Registry (PSR)

Medtronic

Status: Enrolling

Conditions: Aortic, Peripheral Vascular and Venous Disorders; Coronary Artery Disease; Cardiovascular Disorders; Urological Disorders; Digestive Disorders; Neurovascular; Intracranial Aneurysm; Mechanical Circulatory Support; Surgical Procedures, Operative; Ear, Nose and Throat Disorder; Minimally Invasive Surgical Procedures; Cardiac Rhythm Disorders; Neurological Disorders; Respiratory Therapy; Diagnostic Techniques and Procedures; Renal Insufficiency

Study type: Observational

Funder types: Industry

Identifiers

NCT01524276

PSR

Details and patient eligibility

About

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.

Enrollment: 100,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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