ClinicalTrials.gg
RecruitingNCT04073420Updated Sep 25, 2026

Medtronic Cardiac Surgery PMCF Registry

An observational study in Valve Disease, Heart, sponsored by Medtronic Cardiac Surgery. Recruiting at 26 sites in 10 countries. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Medtronic Cardiac Surgery (part of Medtronic) · Observational

From the registry’s dates

  • Started Dec 2019; still recruiting 6 years 11 months later.
Updated Sep 25, 2026Study contact changedGo to Updates ↓

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Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
2,700
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 17 studies in Heart Valve Diseases by Medtronic — 3 open to participants now, 3 under way, none of them phase 3. Heart Valve Diseases · Medtronic.

Started
2019
the only one that year
Observational
6 of 17
1 open now
Registered
16th of 17
by date

Among the 17 studies in Heart Valve Diseases by Medtronic, this one is the only one that started in 2019, is one of 6 observational ones, and was the 16th registered.

Heart Valve Diseases

554 studies on the registry are indexed under Heart Valve Diseases; 164 are open to participants now.

Browse Heart Valve Diseases studies →

Open to participants now

3 of the 17 studies in Heart Valve Diseases by Medtronic are open now, in 12 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 3 open studies →

Who these studies take

Of the 118 Heart Valve Diseases studies recruiting now, 93 (79%) set no upper age limit and 10 (8%) stop at 75 or younger; 16 take children under 18; 15 take healthy volunteers.

This study: all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 17 studies in Heart Valve Diseases by Medtronic, or all of them as a file.
02

Study summary

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

03

Conditions studied

  • Valve Disease, Heart

Browse trials for

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Subjects requiring heart valve therapy replacement and/or repair.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 drug and/or device study that may confound results
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
2,700 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes

Groups and cohorts

  • Surgical Valve Replacement and/or Repair Patients

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

Interventions

  • DeviceSurgical Heart Valve Repair Products

    Surgical heart valve repair products.

  • DeviceSurgical Heart Valve Replacement Products

    Surgical heart valve replacement products.

06

What researchers measure

Primary outcomes

  1. Identify unique failure modes

    Time frame: 10 years

  2. Identify trends in adverse device effects

    Time frame: 10 years

07

Study locations

25 of 26 sites recruiting
  • WellStar Kennestone Hospital
    Marietta, Georgia 30060, United States
    Recruiting
    • Richard Myung, MD · Contact
  • University of Michigan
    Ann Arbor, Michigan 48109, United States
    Recruiting
    • Bolling Steven, MD · Contact
  • Mount Sinai Medical Center
    New York, New York 10029, United States
    Recruiting
    • Ahmed El-Eshmawi, MD · Contact
  • Saint Francis Hospital
    Roslyn, New York 11576, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • Saint Josephs Hospital Health Center
    Syracuse, New York 13203, United States
    Recruiting
    • Karikehalli Dilip, MD · Contact
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
    Recruiting
    • Andrew Vekstein, MD · Contact
  • University Hospitals Cleveland
    Cleveland, Ohio 44106, United States
    Recruiting
    • Yasir Abu-Omar, MD · Contact
  • University of Pittsburgh Medical Center UPMC Presbyterian
    Pittsburgh, Pennsylvania 15213, United States
    Recruiting
    • Johannes Bonatti, MD · Contact
  • Baylor St. Luke's Medical Center
    Houston, Texas 77030, United States
    Recruiting
    • Kenneth Liao, MD · Contact
  • The Heart Hospital Plano
    Plano, Texas 75093, United States
    Recruiting
    • Timothy George, MD · Contact
  • Inova
    Falls Church, Virginia 22042, United States
    Recruiting
    • Eric Sarin, MD · Contact
  • Allgemeines Krankenhaus - Universitätskliniken Wien
    Vienna, 1090, Austria
    Recruiting
    • Martin Andreas, Prof · Contact
  • UZ Leuven
    Leuven, 3000, Belgium
    Recruiting
    • Tom Verbelen, MD · Contact
  • Hôpital Haut-Lévêque - CHU de Bordeaux
    Pessac, 33604, France
    Recruiting
    • Louis Labrousse, Prof · Contact
  • Schüchtermann-Klinik
    Bad Rothenfelde, 49214, Germany
    Recruiting
    • Nicolas Doll, Prof · Contact
  • Herzzentrum Dresden GmbH Universitätsklinik
    Dresden, 01307, Germany
    Recruiting
    • Klaus Matschke, MD · Contact
  • Universitätsklinikum Düsseldorf
    Düsseldorf, 40225, Germany
    Recruiting
    • Christina Ballazs, MD · Contact
  • Albertinen-Herz- und Gefäßzentrum
    Hamburg, 22457, Germany
    Recruiting
    • Friedrich-Christian Rieβ, Prof · Contact
  • Herzzentrum Leipzig
    Leipzig, Germany
    Recruiting
    • Michael Borger, MD · Contact
  • Deutsches Herzzentrum München Klinik an der TU München
    München, 80636, Germany
    Recruiting
    • Keti Vitanova, MD · Contact
  • Onassis Cardiac Surgery Center
    Athens, 17674, Greece
    Recruiting
    • George Stavridis, MD · Contact
  • Ospedale Pasquinucci Massa
    Massa, 54100, Italy
    Recruiting
    • Marco Solinas, MD · Contact
  • IRCCS Policlinico
    San Donato, Italy
    Recruiting
    • Dr. Andrea Daprati · Contact
  • Leids Universitair Medisch Centrum
    Leiden, Netherlands
    Recruiting
    • Jerry Braun, MD · Contact
  • Hospital Regional Universitario Carlos Haya Málaga - Hospital General
    Málaga, 29010, Spain
    Recruiting
    • Enrique Ruiz Alonso, Dr. · Contact
  • Inselspital - Universitätsspital Bern
    Bern, 3010, Switzerland
    Recruiting
    • Matthias Siepe, Prof. Dr. · Contact
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2019 (actual). Primary completion is estimated for Dec 2039, 240 months after the start.

Of 115 observational studies under Heart Valve Diseases, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 212. This study's planned 240 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 19, 2019
First posted
Aug 29, 2019
StartActual
Dec 2, 2019
Primary completionEst.
Dec 31, 2039
CompletionEst.
Dec 31, 2039
Last update
Sep 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Contact
Study contact changed: r•••@medtronic.com · •••2518→r•••@medtronic.com · •••2518. See the current contact
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    Contact Study contact changed: r•••@medtronic.com · •••2518→r•••@medtronic.com · •••2518. See the current contact

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT04073420
Responsible party
Sponsor
First posted
Aug 29, 2019
Start date
Dec 2, 2019
Primary completion
Dec 31, 2039 (estimated)
Completion
Dec 31, 2039 (estimated)
Last update
Sep 25, 2026

Study contacts

Franceen Maroney
Contact
rs.hvtpmcfregistry@medtronic.com
1-800-328-2518
Jessica Halverson
Contact
rs.hvtpmcfregistry@medtronic.com
1-800-328-2518

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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Discussion

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