Medtronic Cardiac Surgery PMCF Registry

Recruiting

• Conditions: Valve Disease, Heart

• 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

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

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

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

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

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