Medtronic Cardiac Surgery PMCF Registry

Part of paid clinical trials in Marietta, Georgia.

Sponsor
Medtronic Cardiac Surgery
Study ID
NCT04073420
Status
Recruiting

Conditions

  • Valve Disease, Heart

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Surgical Heart Valve Repair Products — DEVICE
    Surgical heart valve repair products.
  • Surgical Heart Valve Replacement Products — DEVICE
    Surgical heart valve replacement products.

Study Details

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

Key Dates

Start date
Dec 2, 2019
Status verified
Apr 2026
Primary completion
Dec 31, 2039
Completion
Dec 31, 2039

Study Design

Enrollment
2,700 participants (estimated)

Arms

  • Arm: Surgical Valve Replacement and/or Repair Patients

Primary Outcome Measure

Identify unique failure modes [ Time Frame: 10 years ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
WellStar Kennestone HospitalMariettaGeorgia30060
Richard Myung, MD
University of MichiganAnn ArborMichigan48109
Bolling Steven, MD
Mount Sinai Medical CenterNew YorkNew York10029
Ahmed El-Eshmawi, MD
Saint Francis HospitalRoslynNew York11576-
Saint Josephs Hospital Health CenterSyracuseNew York13203
Karikehalli Dilip, MD
Duke University Medical CenterDurhamNorth Carolina27710
Andrew Vekstein, MD
University Hospitals ClevelandClevelandOhio44106
Yasir Abu-Omar, MD
University of Pittsburgh Medical Center UPMC PresbyterianPittsburghPennsylvania15213
Johannes Bonatti, MD
Baylor St. Luke's Medical CenterHoustonTexas77030
Kenneth Liao, MD
The Heart Hospital PlanoPlanoTexas75093
Timothy George, MD
InovaFalls ChurchVirginia22042
Eric Sarin, MD

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