Valve Disease, HeartNCT04073420
Medtronic Cardiac Surgery PMCF Registry
An observational study of Valve Disease, Heart, run by Medtronic Cardiac Surgery at 26 sites in 10 countries.
Trial summary
This registry is being conducted to support ongoing post-market surveillance activities. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Valve Disease, Heart
- What is being tested?
- Surgical Heart Valve Repair Products and Surgical Heart Valve Replacement Products
- Type of treatment
- Medical device
- How many people
- 2,700 participants
- Where
- 26 sitesin 10 countries
- Study dates
- 2 Dec 2019to 31 Dec 2039
- How long will I take part?
- 10 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects requiring heart valve therapy replacement and/or repair.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
26 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
26 sites in 10 countries
United States11 sites, 10 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Bolling Steven, MD
- Recruiting
University Hospitals Cleveland
Cleveland, Ohio, 44106
Yasir Abu-Omar, MD
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Andrew Vekstein, MD
- Recruiting
Inova
Falls Church, Virginia, 22042
Eric Sarin, MD
- Recruiting
Baylor St. Luke's Medical Center
Houston, Texas, 77030
Kenneth Liao, MD
- Recruiting
WellStar Kennestone Hospital
Marietta, Georgia, 30060
Richard Myung, MD
- Recruiting
Mount Sinai Medical Center
New York, New York, 10029
Ahmed El-Eshmawi, MD
- Recruiting
University of Pittsburgh Medical Center UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213
Johannes Bonatti, MD
- Recruiting
The Heart Hospital Plano
Plano, Texas, 75093
Timothy George, MD
- Withdrawn
Saint Francis Hospital
Roslyn, New York, 11576
- Recruiting
Saint Josephs Hospital Health Center
Syracuse, New York, 13203
Karikehalli Dilip, MD
Germany6 sites, 6 recruiting
- Recruiting
Schüchtermann-Klinik
Bad Rothenfelde, 49214
Nicolas Doll, Prof
- Recruiting
Herzzentrum Dresden GmbH Universitätsklinik
Dresden, 01307
Klaus Matschke, MD
- Recruiting
Universitätsklinikum Düsseldorf
Düsseldorf, 40225
Christina Ballazs, MD
- Recruiting
Albertinen-Herz- und Gefäßzentrum
Hamburg, 22457
Friedrich-Christian Rieβ, Prof
- Recruiting
Herzzentrum Leipzig
Leipzig
Michael Borger, MD
- Recruiting
Deutsches Herzzentrum München Klinik an der TU München
München, 80636
Keti Vitanova, MD
Italy2 sites, 2 recruiting
- Recruiting
Ospedale Pasquinucci Massa
Massa, 54100
Marco Solinas, MD
- Recruiting
IRCCS Policlinico
San Donato
Dr. Andrea Daprati
Austria1 site, 1 recruiting
- Recruiting
Allgemeines Krankenhaus - Universitätskliniken Wien
Vienna, 1090
Martin Andreas, Prof
France1 site, 1 recruiting
- Recruiting
Hôpital Haut-Lévêque - CHU de Bordeaux
Pessac, 33604
Louis Labrousse, Prof
Greece1 site, 1 recruiting
- Recruiting
Onassis Cardiac Surgery Center
Athens, 17674
George Stavridis, MD
Netherlands1 site, 1 recruiting
- Recruiting
Leids Universitair Medisch Centrum
Leiden
Jerry Braun, MD
Spain1 site, 1 recruiting
- Recruiting
Hospital Regional Universitario Carlos Haya Málaga - Hospital General
Málaga, 29010
Enrique Ruiz Alonso, Dr.
Switzerland1 site, 1 recruiting
- Recruiting
Inselspital - Universitätsspital Bern
Bern, 3010
Matthias Siepe, Prof. Dr.
About this study
Official title: Medtronic Cardiac Surgery Post Market Clinical Follow-up Registry
This registry is being conducted to support ongoing post-market surveillance activities.
- Conditions
- Valve Disease, Heart
- Being tested
- Surgical Heart Valve Repair Products, Surgical Heart Valve Replacement Products
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical Heart Valve Repair ProductsDevice
Surgical heart valve repair products.
Surgical Heart Valve Replacement ProductsDevice
Surgical heart valve replacement products.
| Study group | Role | What they receive |
|---|---|---|
| Surgical Valve Replacement and/or Repair Patients | Not described Receives: Device: Surgical Heart Valve Repair Products; Device: Surgical Heart Valve Replacement Products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify unique failure modes
Measured: 10 years
Identify trends in adverse device effects
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study start2 Dec 2019
- Primary completion31 Dec 2039 (estimated)
- Study completion31 Dec 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valve Disease, HeartStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,700 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Surgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04073420
- Sponsor's protocol ID
- MDT18061SUR003
- Status last verified
- Apr 2026
- First submitted
- 19 Aug 2019
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes