Medtronic Cardiac Surgery PMCF Registry

April 11, 2024 updated by: Medtronic Cardiac Surgery

Medtronic Cardiac Surgery Post Market Clinical Follow-up Registry

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
      • Wien, Austria, 1090
        • Recruiting
        • Allgemeines Krankenhaus - Universitätskliniken Wien
        • Contact:
          • Martin Andreas, Prof
  • Belgium
      • Leuven, Belgium, 3000
        • Recruiting
        • UZ Leuven
        • Contact:
          • Wouter Oosterlinck, Prof
  • France
      • Pessac, France, 33604
        • Recruiting
        • Hôpital Haut-Lévêque - CHU de Bordeaux
        • Contact:
          • Louis Labrousse, Prof
  • Germany
      • Bad Rothenfelde, Germany, 49214
        • Recruiting
        • Schüchtermann-Klinik
        • Contact:
          • Nicolas Doll, Prof
      • Dresden, Germany, 01307
        • Recruiting
        • Herzzentrum Dresden GmbH Universitätsklinik
        • Contact:
          • Klaus Matschke, MD
      • Düsseldorf, Germany, 40225
        • Recruiting
        • Universitatsklinikum Dusseldorf
        • Contact:
          • Payam Akhyari, Prof. Dr.
      • Hamburg, Germany, 22457
        • Recruiting
        • Albertinen-Herz- und Gefäßzentrum
        • Contact:
          • Friedrich-Christian Reiss, Prof
      • Leipzig, Germany
        • Recruiting
        • Herzzentrum Leipzig
        • Contact:
          • Michael Borger, MD
      • München, Germany, 80636
        • Recruiting
        • Deutsches Herzzentrum München Klinik an der TU München
        • Contact:
          • Markus Krane, Prof
  • Greece
      • Athens, Greece, 17674
        • Recruiting
        • Onassis Cardiac Surgery Center
        • Contact:
          • George Stavridis, MD
  • Italy
      • Massa, Italy, 54100
        • Recruiting
        • Ospedale Pasquinucci Massa
        • Contact:
          • Marco Solinas, MD
      • San Donato, Italy
        • Recruiting
        • IRCCS Policlinico
        • Contact:
          • Dr. Andrea Garatti
  • Netherlands
      • Leiden, Netherlands
        • Recruiting
        • Leids Universitair Medisch Centrum
        • Contact:
          • Jerry Braun, MD
  • Spain
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Regional Universitario Carlos Haya Málaga - Hospital General
        • Contact:
          • Enrique Ruiz Alonso, Dr.
  • Switzerland
      • Bern, Switzerland, 3010
        • Recruiting
        • Inselspital - Universitätsspital Bern
        • Contact:
          • Matthias Siepe, Prof. Dr.
  • United States
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Recruiting
        • Wellstar Kennestone Hospital
        • Contact:
          • Richard Myung, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Contact:
          • Bolling Steven, MD
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai Medical Center
        • Contact:
          • Ahmed El-Eshmawi, MD
      • Roslyn, New York, United States, 11576
        • Recruiting
        • Saint Francis Hospital
        • Contact:
          • Newell Robinson, MD
      • Syracuse, New York, United States, 13203
        • Recruiting
        • Saint Josephs Hospital Health Center
        • Contact:
          • Karikehalli Dilip, MD
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Contact:
          • Donald Glower, MD
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland
        • Contact:
          • Alan Markowitz, MD
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh Medical Center UPMC Presbyterian
        • Contact:
          • Johannes Bonatti, MD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor St. Luke's Medical Center
        • Contact:
          • Kenneth Liao, MD
      • Plano, Texas, United States, 75093
        • Recruiting
        • The Heart Hospital Plano
        • Contact:
          • Timothy George, MD
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Recruiting
        • Inova
        • Contact:
          • Eric Sarin, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects requiring heart valve therapy replacement and/or repair.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surgical Valve Replacement and/or Repair Patients
Device: Surgical Heart Valve Repair Products
Surgical heart valve repair products.
Device: Surgical Heart Valve Replacement Products
Surgical heart valve replacement products.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Identify unique failure modes
Time Frame: 10 years
10 years
Identify trends in adverse device effects
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2019

Primary Completion (Estimated)

December 31, 2039

Study Completion (Estimated)

December 31, 2039

Study Registration Dates

First Submitted

August 19, 2019

First Submitted That Met QC Criteria

August 28, 2019

First Posted (Actual)

August 29, 2019

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDT18061SUR003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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