Medtronic Cardiac Surgery PMCF Registry

Medtronic

Status: Enrolling

Conditions: Valve Disease, Heart

Treatments: Device: Surgical Heart Valve Repair Products; Device: Surgical Heart Valve Replacement Products

Study type: Observational

Funder types: Industry

Identifiers

NCT04073420

MDT18061SUR003

Details and patient eligibility

About

This registry is being conducted to support ongoing post-market surveillance activities.

Enrollment: 2,700 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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 product
3. Patient is within enrollment window of treatment/therapy received at the time of their initial Registry enrollment, or meets criteria for retrospective enrollment

Exclusion criteria

1. Patient who is, or is expected to be, inaccessible for follow-up
2. Patient prohibited from participation by local law
3. Patient is currently enrolled in or plans to enroll in any concurrent investigational drug and/or device study that may confound results

Trial design

2,700 participants in 1 patient group

Surgical Valve Replacement and/or Repair Patients

Treatment:

Device: Surgical Heart Valve Replacement Products

Device: Surgical Heart Valve Repair Products