Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT02505074

Natural History of Melody Valve in the Mitral and Tricuspid Position

Sponsor: Boston Children's Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

Any - 18 Years

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2014-12

Completion Date

2025-06

Last Updated

2026-07-15

Healthy Volunteers

No

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.