Recruiting NCT04073420
Medtronic Cardiac Surgery PMCF Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Surgical Heart Valve Repair Products, Surgical Heart Valve Replacement Products.
- Who it may be relevant to
- Registry conditions: Valve Disease, Heart. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Austria, Belgium, France, Germany +5
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Medtronic Cardiac Surgery Post Market Clinical Follow-up Registry
Overview
This registry is being conducted to support ongoing post-market surveillance activities.
Interventions
- Device Surgical Heart Valve Repair Products
Surgical heart valve repair products. - Device Surgical Heart Valve Replacement Products
Surgical heart valve replacement products.
Primary outcome measures
- Identify unique failure modes [Time frame: 10 years]
- Identify trends in adverse device effects [Time frame: 10 years]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 11 centers
- WellStar Kennestone Hospital — Marietta
- University of Michigan — Ann Arbor
- Mount Sinai Medical Center — New York
- Saint Francis Hospital — Roslyn
- Saint Josephs Hospital Health Center — Syracuse
- Duke University Medical Center — Durham
- University Hospitals Cleveland — Cleveland
- University of Pittsburgh Medical Center UPMC Presbyterian — Pittsburgh
- … and 3 more centers
Germany · 6 centers
- Schüchtermann-Klinik — Bad Rothenfelde
- Herzzentrum Dresden GmbH Universitätsklinik — Dresden
- Universitätsklinikum Düsseldorf — Düsseldorf
- Albertinen-Herz- und Gefäßzentrum — Hamburg
- Herzzentrum Leipzig — Leipzig
- Deutsches Herzzentrum München Klinik an der TU München — München
Italy · 2 centers
- Ospedale Pasquinucci Massa — Massa
- IRCCS Policlinico — San Donato
Austria · 1 center
- Allgemeines Krankenhaus - Universitätskliniken Wien — Vienna
Belgium · 1 center
- UZ Leuven — Leuven
France · 1 center
- Hôpital Haut-Lévêque - CHU de Bordeaux — Pessac
Greece · 1 center
- Onassis Cardiac Surgery Center — Athens
Netherlands · 1 center
- Leids Universitair Medisch Centrum — Leiden
Spain · 1 center
- Hospital Regional Universitario Carlos Haya Málaga - Hospital General — Málaga
Switzerland · 1 center
- Inselspital - Universitätsspital Bern — Bern
Identifiers
NCT: NCT04073420 · MDT18061SUR003