Product Surveillance Registry

Recruiting

• Conditions: Cardiovascular Disorders; Minimally Invasive Surgical Procedures; Neurovascular; Neurological Disorders; Intracranial Aneurysm; Mechanical Circulatory Support; Coronary Artery Disease; Ear, Nose and Throat Disorder; Cardiac Rhythm Disorders; Urological Disorders

• Registration Number: NCT01524276
• Lead Sponsor: Medtronic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-30
• Study First Submitted QC: 2012-01-30
• Study First Posted: 2012-02-01
• Status Verified: 2024-12
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-04
• Primary Completion: 2040-01
• Study Completion: 2040-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and Effectiveness of Market Released products	Every 6-12 months (Therapy-dependent)