Medtronic Cardiac Surgery PMCF Registry

Valve Disease, Heart Clinical Trial

Official title:

Medtronic Cardiac Surgery Post Market Clinical Follow-up Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04073420
• Other study ID #: MDT18061SUR003
• Status: Recruiting
• Start date: December 2, 2019
• Est. completion date: December 31, 2039

Study information

• Verified date: April 2024
• Source: Medtronic Cardiac Surgery
• Contact: Lisa Slusser
• Phone: 1-800-328-2518
• Email: rs.hvtpmcfregistry[@]medtronic.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2700
• Est. completion date: December 31, 2039
• Est. primary completion date: December 31, 2039
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

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

Related Conditions & MeSH terms

• Heart Valve Diseases
• Valve Disease, Heart

Intervention

Device:
• Surgical Heart Valve Repair Products
Surgical heart valve repair products.
• Surgical Heart Valve Replacement Products
Surgical heart valve replacement products.

Locations

Country	Name	City	State
Austria	Allgemeines Krankenhaus - Universitätskliniken Wien	Wien
Belgium	UZ Leuven	Leuven
France	Hôpital Haut-Lévêque - CHU de Bordeaux	Pessac
Germany	Schüchtermann-Klinik	Bad Rothenfelde
Germany	Herzzentrum Dresden GmbH Universitätsklinik	Dresden
Germany	Universitätsklinikum Düsseldorf	Düsseldorf
Germany	Albertinen-Herz- und Gefäßzentrum	Hamburg
Germany	Herzzentrum Leipzig	Leipzig
Germany	Deutsches Herzzentrum München Klinik an der TU München	München
Greece	Onassis Cardiac Surgery Center	Athens
Italy	Ospedale Pasquinucci Massa	Massa
Italy	IRCCS Policlinico	San Donato
Netherlands	Leids Universitair Medisch Centrum	Leiden
Spain	Hospital Regional Universitario Carlos Haya Málaga - Hospital General	Málaga
Switzerland	Inselspital - Universitätsspital Bern	Bern
United States	University of Michigan	Ann Arbor	Michigan
United States	University Hospitals Cleveland	Cleveland	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Inova	Falls Church	Virginia
United States	Baylor St. Luke's Medical Center	Houston	Texas
United States	WellStar Kennestone Hospital	Marietta	Georgia
United States	Mount Sinai Medical Center	New York	New York
United States	University of Pittsburgh Medical Center UPMC Presbyterian	Pittsburgh	Pennsylvania
United States	The Heart Hospital Plano	Plano	Texas
United States	Saint Francis Hospital	Roslyn	New York
United States	Saint Josephs Hospital Health Center	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Surgery

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  France,  Germany,  Greece,  Italy,  Netherlands,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify unique failure modes		10 years
Primary	Identify trends in adverse device effects		10 years