Medtronic Cardiac Surgery PMCF Registry

Medtronic Cardiac Surgery Post Market Clinical Follow-up Registry

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04073420

Enrollment

2700

Registered

2019-08-29

Start date

2019-12-02

Completion date

2039-12-31

Last updated

2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Valve Disease, Heart

Brief summary

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

Interventions

DEVICESurgical Heart Valve Repair Products

Surgical heart valve repair products.

DEVICESurgical Heart Valve Replacement Products

Surgical heart valve replacement products.

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame
Identify unique failure modes	10 years
Identify trends in adverse device effects	10 years

Countries

Austria, Belgium, France, Germany, Greece, Italy, Netherlands, Spain, Switzerland, United States

Contacts

CONTACTLisa Slusser

rs.hvtpmcfregistry@medtronic.com1-800-328-2518

CONTACTJessica Halverson