Medtronic Cardiac Surgery PMCF Registry

NCT ID: NCT04073420

Last Updated: 2025-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-02

Study Completion Date

2039-12-31

Brief Summary

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

Detailed Description

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Conditions

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Valve Disease, Heart

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Surgical Valve Replacement and/or Repair Patients

Surgical Heart Valve Repair Products

Intervention Type DEVICE

Surgical heart valve repair products.

Surgical Heart Valve Replacement Products

Intervention Type DEVICE

Surgical heart valve replacement products.

Interventions

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Surgical Heart Valve Repair Products

Surgical heart valve repair products.

Intervention Type DEVICE

Surgical Heart Valve Replacement Products

Surgical heart valve replacement products.

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Cardiac Surgery

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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WellStar Kennestone Hospital

Marietta, Georgia, United States

Site Status RECRUITING

University of Michigan

Ann Arbor, Michigan, United States

Site Status RECRUITING

Mount Sinai Medical Center

New York, New York, United States

Site Status RECRUITING

Saint Francis Hospital

Roslyn, New York, United States

Site Status WITHDRAWN

Saint Josephs Hospital Health Center

Syracuse, New York, United States

Site Status RECRUITING

Duke University Medical Center

Durham, North Carolina, United States

Site Status RECRUITING

University Hospitals Cleveland

Cleveland, Ohio, United States

Site Status RECRUITING

University of Pittsburgh Medical Center UPMC Presbyterian

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Baylor St. Luke's Medical Center

Houston, Texas, United States

Site Status RECRUITING

The Heart Hospital Plano

Plano, Texas, United States

Site Status RECRUITING

Inova

Falls Church, Virginia, United States

Site Status RECRUITING

Allgemeines Krankenhaus - Universitätskliniken Wien

Vienna, , Austria

Site Status RECRUITING

UZ Leuven

Leuven, , Belgium

Site Status RECRUITING

Hôpital Haut-Lévêque - CHU de Bordeaux

Pessac, , France

Site Status RECRUITING

Schüchtermann-Klinik

Bad Rothenfelde, , Germany

Site Status RECRUITING

Herzzentrum Dresden GmbH Universitätsklinik

Dresden, , Germany

Site Status RECRUITING

Universitätsklinikum Düsseldorf

Düsseldorf, , Germany

Site Status RECRUITING

Albertinen-Herz- und Gefäßzentrum

Hamburg, , Germany

Site Status RECRUITING

Herzzentrum Leipzig

Leipzig, , Germany

Site Status RECRUITING

Deutsches Herzzentrum München Klinik an der TU München

München, , Germany

Site Status RECRUITING

Onassis Cardiac Surgery Center

Athens, , Greece

Site Status RECRUITING

Ospedale Pasquinucci Massa

Massa, , Italy

Site Status RECRUITING

IRCCS Policlinico

San Donato, , Italy

Site Status RECRUITING

Leids Universitair Medisch Centrum

Leiden, , Netherlands

Site Status RECRUITING

Hospital Regional Universitario Carlos Haya Málaga - Hospital General

Málaga, , Spain

Site Status RECRUITING

Inselspital - Universitätsspital Bern

Bern, , Switzerland

Site Status RECRUITING

Countries

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United States Austria Belgium France Germany Greece Italy Netherlands Spain Switzerland

Central Contacts

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Lisa Slusser

Role: CONTACT

1-800-328-2518

Jessica Halverson

Role: CONTACT

1-800-328-2518

Facility Contacts

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Richard Myung, MD

Role: primary

Bolling Steven, MD

Role: primary

Ahmed El-Eshmawi, MD

Role: primary

Karikehalli Dilip, MD

Role: primary

Brittany Zwishchenberger, MD

Role: primary

Yasir Abu-Omar, MD

Role: primary

Johannes Bonatti, MD

Role: primary

Kenneth Liao, MD

Role: primary

Timothy George, MD

Role: primary

Eric Sarin, MD

Role: primary

Martin Andreas, Prof

Role: primary

Tom Verbelen, MD

Role: primary

Louis Labrousse, Prof

Role: primary

Nicolas Doll, Prof

Role: primary

Klaus Matschke, MD

Role: primary

Christina Ballazs, MD

Role: primary

Friedrich-Christian Rieβ, Prof

Role: primary

Michael Borger, MD

Role: primary

Keti Vitanova, MD

Role: primary

George Stavridis, MD

Role: primary

Marco Solinas, MD

Role: primary

Dr. Andrea Daprati

Role: primary

Jerry Braun, MD

Role: primary

Enrique Ruiz Alonso, Dr.

Role: primary

Matthias Siepe, Prof. Dr.

Role: primary

Other Identifiers

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MDT18061SUR003

Identifier Type: -

Identifier Source: org_study_id

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