Medtronic Cardiac Surgery PMCF Registry

NCT04073420 | Recruiting FDA Device

• 1 other identifier: MDT18061SUR003
• Study Type: observational
• Target: 2,700
• Locations: 10 countries
• Sites: 26

Brief Summary

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

Conditions

Valve Disease, Heart

Outcome Measures

Primary Outcomes (2)

• Identify unique failure modes

  10 years

• Identify trends in adverse device effects

  10 years

Study Arms (1)

Surgical Valve Replacement and/or Repair Patients

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

Interventions

Surgical Heart Valve Repair Products DEVICE

Surgical heart valve repair products.

Surgical Valve Replacement and/or Repair Patients

Surgical Heart Valve Replacement Products DEVICE

Surgical heart valve replacement products.

Surgical Valve Replacement and/or Repair Patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects requiring heart valve therapy replacement and/or repair.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Surgery: lead

Study Sites (26)

WellStar Kennestone Hospital

Marietta, Georgia, 30060, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Mount Sinai Medical Center

New York, New York, 10029, United States

RECRUITING

Saint Francis Hospital

Roslyn, New York, 11576, United States

WITHDRAWN

Saint Josephs Hospital Health Center

Syracuse, New York, 13203, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

University Hospitals Cleveland

Cleveland, Ohio, 44106, United States

RECRUITING

University of Pittsburgh Medical Center UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Baylor St. Luke's Medical Center

Houston, Texas, 77030, United States

RECRUITING

The Heart Hospital Plano

Plano, Texas, 75093, United States

RECRUITING

Inova

Falls Church, Virginia, 22042, United States

RECRUITING

Allgemeines Krankenhaus - Universitätskliniken Wien

Vienna, 1090, Austria

RECRUITING

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

Hôpital Haut-Lévêque - CHU de Bordeaux

Pessac, 33604, France

RECRUITING

Schüchtermann-Klinik

Bad Rothenfelde, 49214, Germany

RECRUITING

Herzzentrum Dresden GmbH Universitätsklinik

Dresden, 01307, Germany

RECRUITING

Universitätsklinikum Düsseldorf

Düsseldorf, 40225, Germany

RECRUITING

Albertinen-Herz- und Gefäßzentrum

Hamburg, 22457, Germany

RECRUITING

Herzzentrum Leipzig

Leipzig, Germany

RECRUITING

Deutsches Herzzentrum München Klinik an der TU München

München, 80636, Germany

RECRUITING

Onassis Cardiac Surgery Center

Athens, 17674, Greece

RECRUITING

Ospedale Pasquinucci Massa

Massa, 54100, Italy

RECRUITING

IRCCS Policlinico

San Donato, Italy

RECRUITING

Leids Universitair Medisch Centrum

Leiden, Netherlands

RECRUITING

Hospital Regional Universitario Carlos Haya Málaga - Hospital General

Málaga, 29010, Spain

RECRUITING

Inselspital - Universitätsspital Bern

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Lisa Slusser

CONTACT

1-800-328-2518; rs.hvtpmcfregistry@medtronic.com

Jessica Halverson

CONTACT

1-800-328-2518; rs.hvtpmcfregistry@medtronic.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 10 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 29, 2019
• Study Start: December 2, 2019
• Primary Completion (Estimated): December 31, 2039
• Study Completion (Estimated): December 31, 2039
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

DE (6); FR (1); US (11); BE (1); NL (1); ES (1); CH (1); IT (2); GR (1); AU (1)