Recruiting

Observational Study

Sponsor:

Medtronic Cardiac Surgery

Code:

NCT04073420

Conditions

Valve Disease, Heart

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Surgical Heart Valve Repair Products

Surgical Heart Valve Replacement Products

Study Details

Brief summary:

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

Conditions

Valve Disease, Heart

Study ID

NCT04073420

Start date

Dec 2, 2019

Status verified date

Apr, 2026

Completion date

Dec 31, 2039

Anticipated

Primary completion date

Dec 31, 2039

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Enrollment

2700 participants

Anticipated

Interventions and Outcome Measures

Arms

Surgical Valve Replacement and/or Repair Patients

Interventions

Surgical Heart Valve Repair Products

Surgical heart valve repair products.

Surgical Heart Valve Replacement Products

Surgical heart valve replacement products.

Primary outcome measure

  • Identify unique failure modes [ Time Frame: 10 years ]
  • Identify trends in adverse device effects [ Time Frame: 10 years ]

Central Contacts and Locations

Locations

WellStar Kennestone Hospital

Recruiting

Marietta, Georgia, United States, 30060

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Mount Sinai Medical Center

Recruiting

New York, New York, United States, 10029

Saint Josephs Hospital Health Center

Recruiting

Syracuse, New York, United States, 13203

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

University Hospitals Cleveland

Recruiting

Cleveland, Ohio, United States, 44106

University of Pittsburgh Medical Center UPMC Presbyterian

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Baylor St. Luke's Medical Center

Recruiting

Houston, Texas, United States, 77030

The Heart Hospital Plano

Recruiting

Plano, Texas, United States, 75093

Inova

Recruiting

Falls Church, Virginia, United States, 22042

More Information

Sponsor

Medtronic Cardiac Surgery

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Medtronic Cardiac Surgery on 2026-04-13.