RECRUITING
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Medtronic Cardiac Surgery PMCF Registry
This registry is being conducted to support ongoing post-market surveillance activities.
Conditions:
🦠 Valve Disease, Heart
🗓️ Study Start (Actual) 2 December 2019
🗓️ Primary Completion (Estimated) 31 December 2039
✅ Study Completion (Estimated) 31 December 2039
👥 Enrollment (Estimated) 2700
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Marietta, Georgia, United States
📍 Ann Arbor, Michigan, United States
📍 New York, New York, United States
📍 Roslyn, New York, United States
📍 Syracuse, New York, United States
📍 Durham, North Carolina, United States
📍 Cleveland, Ohio, United States
📍 Pittsburgh, Pennsylvania, United States
📍 Houston, Texas, United States
📍 Plano, Texas, United States
📍 Falls Church, Virginia, United States
📍 Wien, Austria
📍 Leuven, Belgium
📍 Pessac, France
📍 Bad Rothenfelde, Germany
📍 Dresden, Germany
📍 Düsseldorf, Germany
📍 Hamburg, Germany
📍 Leipzig, Germany
📍 München, Germany
📍 Athens, Greece
📍 Massa, Italy
📍 San Donato, Italy
📍 Leiden, Netherlands
📍 Málaga, Spain
📍 Bern, Switzerland
More locations available...

📋 Eligibility Criteria

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
Ages Eligible for Study: N/A to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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 Registration Dates

  • First Submitted 19 August 2019
  • First Submitted that Met QC Criteria 28 August 2019
  • First Posted 29 August 2019

Study Record Updates

  • Last Update Submitted that Met QC Criteria 10 July 2024
  • Last Update Posted 11 July 2024
  • Last Verified July 2024
I'm interested ...!!