Actively Recruiting
Medtronic Cardiac Surgery Post Market Clinical Follow-up Registry for Surgical Heart Valve Repair and Replacement
Led by Medtronic Cardiac Surgery · Updated on 2026-04-13
2700
Participants Needed
26
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This registry observes patients with heart valve disease who have undergone or are planned to undergo surgical heart valve repair or replacement. The purpose is to support ongoing post-market surveillance of these devices by monitoring their performance and safety over time. Participants receive surgical heart valve repair or replacement products as part of their standard care. This study collects information about patients treated with these devices, either prospectively at the time of surgery or retrospectively if treated earlier. The registry follows patients long-term to identify any unique failure modes or adverse device effects. During the study, patients are monitored for up to 10 years to assess device performance and safety trends. Researchers collect data through follow-up visits and medical records to track outcomes related to the surgical valve products. The study helps improve understanding of device durability and safety in real-world patient use.
CONDITIONS
Brief Title
Medtronic Cardiac Surgery PMCF Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 day
Participants undergo surgical heart valve repair or replacement with the device.
1 surgical procedure visit
Duration - Up to 10 years
Participants are followed over time to monitor device performance and identify any adverse effects.
Periodic follow-up visits based on local practice
Trial Site Locations
Total: 26 locations
1
WellStar Kennestone Hospital
Marietta, Georgia, United States, 30060
Actively Recruiting
2
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
3
Mount Sinai Medical Center
New York, New York, United States, 10029
Actively Recruiting
4
Saint Francis Hospital
Roslyn, New York, United States, 11576
Withdrawn
5
Saint Josephs Hospital Health Center
Syracuse, New York, United States, 13203
Actively Recruiting
6
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
7
University Hospitals Cleveland
Cleveland, Ohio, United States, 44106
Actively Recruiting
8
University of Pittsburgh Medical Center UPMC Presbyterian
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
9
Baylor St. Luke's Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
10
The Heart Hospital Plano
Plano, Texas, United States, 75093
Actively Recruiting
11
Inova
Falls Church, Virginia, United States, 22042
Actively Recruiting
12
Allgemeines Krankenhaus - Universitätskliniken Wien
Vienna, Austria, 1090
Actively Recruiting
13
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
14
Hôpital Haut-Lévêque - CHU de Bordeaux
Pessac, France, 33604
Actively Recruiting
15
Schüchtermann-Klinik
Bad Rothenfelde, Germany, 49214
Actively Recruiting
16
Herzzentrum Dresden GmbH Universitätsklinik
Dresden, Germany, 01307
Actively Recruiting
17
Universitätsklinikum Düsseldorf
Düsseldorf, Germany, 40225
Actively Recruiting
18
Albertinen-Herz- und Gefäßzentrum
Hamburg, Germany, 22457
Actively Recruiting
19
Herzzentrum Leipzig
Leipzig, Germany
Actively Recruiting
20
Deutsches Herzzentrum München Klinik an der TU München
München, Germany, 80636
Actively Recruiting
21
Onassis Cardiac Surgery Center
Athens, Greece, 17674
Actively Recruiting
22
Ospedale Pasquinucci Massa
Massa, Italy, 54100
Actively Recruiting
23
IRCCS Policlinico
San Donato, Italy
Actively Recruiting
24
Leids Universitair Medisch Centrum
Leiden, Netherlands
Actively Recruiting
25
Hospital Regional Universitario Carlos Haya Málaga - Hospital General
Málaga, Spain, 29010
Actively Recruiting
26
Inselspital - Universitätsspital Bern
Bern, Switzerland, 3010
Actively Recruiting
Research Team
L
Lisa Slusser
J
Jessica Halverson
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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