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Recruiting

NCT Number: NCT04073420

Medtronic Cardiac Surgery PMCF Registry

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

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Allgemeines Krankenhaus - Universitätskliniken Wien, Vienna, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 product
  • 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

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

Treatment and study plan

Surgical Heart Valve Repair Products

Device

Surgical heart valve repair products.

Surgical Heart Valve Replacement Products

Device

Surgical heart valve replacement products.

Primary outcomes

  1. Identify unique failure modes

    Time frame: 10 years

  2. Identify trends in adverse device effects

    Time frame: 10 years

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Halverson

CONTACT

[email protected]

1-800-328-2518

Lisa Slusser

CONTACT

[email protected]

1-800-328-2518

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Surgery

Industry

Registry information

Official study title

Medtronic Cardiac Surgery Post Market Clinical Follow-up Registry

Important dates

Study start
2019
Primary completion
2039
Study completion
2039
First posted
Aug 29, 2019
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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