Clinical Trials in Spain / NCT04073420
Recruiting
Observational
Medtronic Cardiac Surgery PMCF Registry
NCT04073420 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Valve Disease, Heart
Investigational drug(s) / intervention(s)
Surgical Heart Valve Repair ProductsSurgical Heart Valve Replacement Products
Surgical Heart Valve Repair Products: Surgical heart valve repair products.
Surgical Heart Valve Replacement Products: Surgical heart valve replacement products.
Study summary
This registry is being conducted to support ongoing post-market surveillance activities.
Eligibility
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 outcome measure(s)
- Identify unique failure modes — 10 years
- Identify trends in adverse device effects — 10 years
Trial sites (26)
| Facility | City | Region | Status |
|---|---|---|---|
| WellStar Kennestone Hospital | Marietta | Georgia | Recruiting |
| University of Michigan | Ann Arbor | Michigan | Recruiting |
| Mount Sinai Medical Center | New York | New York | Recruiting |
| Saint Francis Hospital | Roslyn | New York | Withdrawn |
| Saint Josephs Hospital Health Center | Syracuse | New York | Recruiting |
| Duke University Medical Center | Durham | North Carolina | Recruiting |
| University Hospitals Cleveland | Cleveland | Ohio | Recruiting |
| University of Pittsburgh Medical Center UPMC Presbyterian | Pittsburgh | Pennsylvania | Recruiting |
| Baylor St. Luke's Medical Center | Houston | Texas | Recruiting |
| The Heart Hospital Plano | Plano | Texas | Recruiting |
| Inova | Falls Church | Virginia | Recruiting |
| Allgemeines Krankenhaus - Universitätskliniken Wien | Vienna | Austria | Recruiting |
| UZ Leuven | Leuven | Belgium | Recruiting |
| Hôpital Haut-Lévêque - CHU de Bordeaux | Pessac | France | Recruiting |
| Schüchtermann-Klinik | Bad Rothenfelde | Germany | Recruiting |
| Herzzentrum Dresden GmbH Universitätsklinik | Dresden | Germany | Recruiting |
| Universitätsklinikum Düsseldorf | Düsseldorf | Germany | Recruiting |
| Albertinen-Herz- und Gefäßzentrum | Hamburg | Germany | Recruiting |
| Herzzentrum Leipzig | Leipzig | Germany | Recruiting |
| Deutsches Herzzentrum München Klinik an der TU München | München | Germany | Recruiting |
| Onassis Cardiac Surgery Center | Athens | Greece | Recruiting |
| Ospedale Pasquinucci Massa | Massa | Italy | Recruiting |
| IRCCS Policlinico | San Donato | Italy | Recruiting |
| Leids Universitair Medisch Centrum | Leiden | Netherlands | Recruiting |
| Hospital Regional Universitario Carlos Haya Málaga - Hospital General | Málaga | Spain | Recruiting |
| Inselspital - Universitätsspital Bern | Bern | Switzerland | Recruiting |
More Medtronic Cardiac Surgery trials in Spain
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04073420 on ClinicalTrials.gov ↗ ← All trials in Spain