Medtronic Cardiac Surgery PMCF Registry

Recruiting

• Conditions: Valve Disease, Heart
• Interventions: Device: Surgical Heart Valve Repair Products; Device: Surgical Heart Valve Replacement Products

• Registration Number: NCT04073420
• Lead Sponsor: Medtronic Cardiac Surgery

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-19
• Study First Submitted QC: 2019-08-28
• Study First Posted: 2019-08-29
• Study Start: 2019-12-02
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-10
• Primary Completion: 2039-12-31
• Study Completion: 2039-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2700

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgical Valve Replacement and/or Repair Patients	Surgical Heart Valve Repair Products	-
Surgical Valve Replacement and/or Repair Patients	Surgical Heart Valve Replacement Products	-

Primary Outcome Measures

Name	Time	Method
Identify unique failure modes	10 years
Identify trends in adverse device effects	10 years

Trial Locations

Locations (26)

WellStar Kennestone Hospital; 🇺🇸 Marietta, Georgia, United States

Saint Josephs Hospital Health Center; 🇺🇸 Syracuse, New York, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Mount Sinai Medical Center; 🇺🇸 New York, New York, United States

Saint Francis Hospital; 🇺🇸 Roslyn, New York, United States

University Hospitals Cleveland; 🇺🇸 Cleveland, Ohio, United States

University of Pittsburgh Medical Center UPMC Presbyterian; 🇺🇸 Pittsburgh, Pennsylvania, United States

Baylor St. Luke's Medical Center; 🇺🇸 Houston, Texas, United States

The Heart Hospital Plano; 🇺🇸 Plano, Texas, United States

Inova; 🇺🇸 Falls Church, Virginia, United States

Allgemeines Krankenhaus - Universitätskliniken Wien; 🇦🇹 Wien, Austria

UZ Leuven; 🇧🇪 Leuven, Belgium

Hôpital Haut-Lévêque - CHU de Bordeaux; 🇫🇷 Pessac, France

Schüchtermann-Klinik; 🇩🇪 Bad Rothenfelde, Germany

Herzzentrum Dresden GmbH Universitätsklinik; 🇩🇪 Dresden, Germany

Universitätsklinikum Düsseldorf; 🇩🇪 Düsseldorf, Germany

Onassis Cardiac Surgery Center; 🇬🇷 Athens, Greece

Ospedale Pasquinucci Massa; 🇮🇹 Massa, Italy

Albertinen-Herz- und Gefäßzentrum; 🇩🇪 Hamburg, Germany

Herzzentrum Leipzig; 🇩🇪 Leipzig, Germany

Deutsches Herzzentrum München Klinik an der TU München; 🇩🇪 München, Germany

Leids Universitair Medisch Centrum; 🇳🇱 Leiden, Netherlands

IRCCS Policlinico; 🇮🇹 San Donato, Italy

Hospital Regional Universitario Carlos Haya Málaga - Hospital General; 🇪🇸 Málaga, Spain

Inselspital - Universitätsspital Bern; 🇨🇭 Bern, Switzerland