Natural History of Melody Valve in the Mitral and Tricuspid Position

Summary

The Melody valve has historically been used for pulmonary valve replacements; however it has been more recently used in the mitral and tricuspid positions. This multi-center, retrospective, observational study will review the durability of the Melody valve inserted into the mitral or tricuspid positions.

Patients who have undergone Melody valve insertion into either the mitral or tricuspid positions prior to December, 2014 will be eligible for the study. Basic de-identified patient demographics will be collected as well as select clinical data. Ventricular function and valvar function of the affected valve will be retrospectively reviewed both prior to surgery and following, as well as review of operative data. The investigators will also review the most recent follow up data and any subsequent re-interventions on the Melody valve. Data from all sites will be entered into an external REDCap database, using only de-identified data.

Conditions

• Diseases of Mitral Valve
• Tricuspid Valve Disorder

Interventions

PROCEDURE

Valve replacement with the Melody valve

This study will only review patients who have had the Melody valve surgically inserted into the Mitral and/or Tricuspid positions. We will not be reviewing any other intervention type.

Sponsors & Collaborators

• MOUNT SINAI HOSPITAL

  collaborator OTHER

• Children's Hospital and Medical Center

  collaborator UNKNOWN

• University of California, San Francisco

  collaborator OTHER

• NewYork Presbyterian Hospital

  collaborator UNKNOWN

• The Monroe Carell Jr. Children's Hospital at Vanderbilt

  collaborator UNKNOWN

• Northwell Health

  collaborator OTHER

• Primary Children's Hospital

  collaborator OTHER

• Seattle Children's Hospital

  collaborator OTHER

• Gruppo Ospedaliero San Donato

  collaborator UNKNOWN

• University Hospital Munich

  collaborator OTHER

• University Children's Hospital, Zurich

  collaborator OTHER

• Fondation IUCPQ

  collaborator OTHER

• Hospital for Sick Kids

  collaborator UNKNOWN

• Boston Children's Hospital

  lead OTHER

Principal Investigators

• Sitaram Emani, MD · Cardiovascular Surgeon

Eligibility

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-12-31

Primary Completion

2024-12-31

Completion

2025-06-30