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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medtronic Cardiac Surgery Post Market Clinical Follow-up Registry
- ClinicalTrials.gov ID
- NCT04073420
- Acronym / sponsor ID
- MDT18061SUR003
- Conditions
- Valve Disease, Heart
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,700 participants (estimated)
- Lead sponsor
- Medtronic Cardiac SurgeryIndustry (pharma, biotech, devices)
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 31 Dec 2039 (estimated)
- Study completion
- 31 Dec 2039 (estimated)
- First posted
- 29 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This registry is being conducted to support ongoing post-market surveillance activities.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical Valve Replacement and/or Repair Patients | – | Device: Surgical Heart Valve Repair Products, Device: Surgical Heart Valve Replacement Products |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects requiring heart valve therapy replacement and/or repair.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical Heart Valve Repair ProductsSurgical heart valve repair products. | Device | Surgical Valve Replacement and/or Repair Patients |
| Surgical Heart Valve Replacement ProductsSurgical heart valve replacement products. | Device | Surgical Valve Replacement and/or Repair Patients |
Primary outcome
Identify unique failure modes
Time frame: 10 years
Identify trends in adverse device effects
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
26 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Valve Disease, Heart, run by Medtronic Cardiac Surgery at 26 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Germany, Italy, Austria, Belgium and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Franceen Maroney (1-800-328-2518, rs.hvtpmcfregistry@medtronic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify unique failure modes (time frame: 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.