Clinical trial NCT04073420: Medtronic Cardiac Surgery PMCF Registry
Official title: Medtronic Cardiac Surgery Post Market Clinical Follow-up Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Valve Disease, Heart
Lead sponsor: Medtronic Cardiac Surgery
Sponsor class: INDUSTRY
First posted: 2019-08-29
Enrollment: 2700
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects requiring heart valve therapy replacement and/or repair.

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


Eligibility criteria: 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

Primary outcomes:
measure: Identify unique failure modes
timeFrame: 10 years
measure: Identify trends in adverse device effects
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Marietta
country: United States
facility: WellStar Kennestone Hospital
state: Georgia
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Roslyn
country: United States
facility: Saint Francis Hospital
state: New York
city: Syracuse
country: United States
facility: Saint Josephs Hospital Health Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center UPMC Presbyterian
state: Pennsylvania
city: Houston
country: United States
facility: Baylor St. Luke's Medical Center
state: Texas
city: Plano
country: United States
facility: The Heart Hospital Plano
state: Texas
city: Falls Church
country: United States
facility: Inova
state: Virginia
city: Wien
country: Austria
facility: Allgemeines Krankenhaus - Universitätskliniken Wien
city: Leuven
country: Belgium
facility: UZ Leuven
city: Pessac
country: France
facility: Hôpital Haut-Lévêque - CHU de Bordeaux
city: Bad Rothenfelde
country: Germany
facility: Schüchtermann-Klinik
city: Dresden
country: Germany
facility: Herzzentrum Dresden GmbH Universitätsklinik
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Hamburg
country: Germany
facility: Albertinen-Herz- und Gefäßzentrum
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig
city: München
country: Germany
facility: Deutsches Herzzentrum München Klinik an der TU München
city: Athens
country: Greece
facility: Onassis Cardiac Surgery Center
city: Massa
country: Italy
facility: Ospedale Pasquinucci Massa
city: San Donato
country: Italy
facility: IRCCS Policlinico
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum
city: Málaga
country: Spain
facility: Hospital Regional Universitario Carlos Haya Málaga - Hospital General
city: Bern
country: Switzerland
facility: Inselspital - Universitätsspital Bern
Study officials:
References: