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Melody Transcatheter Pulmonary Valve Study: Post Approval Study of the Investigational Device Exemption Cohort | Clinical Trials | Clareo Health

COMPLETEDNA

Melody Transcatheter Pulmonary Valve Study: Post Approval Study of the Investigational Device Exemption Cohort

Implantation of the Medtronic Melody Transcatheter Pulmonary Valve in Patients With Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduits: A Feasibility Study

NCT00740870•Medtronic Cardiovascular

View on ClinicalTrials.gov

Summary

The primary objective is to confirm the long-term functionality of implantation of the Medtronic Melody TPV at 5 years is no worse than the historical control established through literature review. The secondary objectives are to evaluate long-term functionality at 10 years and to assess safety, procedural success, and clinical utility of transcatheter implantation of the Melody TPV.

Detailed Description

The primary objective is to confirm the long-term functionality of implantation of the Medtronic Melody TPV at 5 years is no worse than the historical control established through literature review. The secondary objectives is to evaluate long-term functionality at 10 years and to assess safety, procedural success, and clinical utility of transcatheter implantation of the Melody TPV.

Eligibility

Age

5 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age greater than or equal to 5 years of age
•Weight greater than or equal to 30 kilograms
•Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16 mm in diameter when originally implanted, or a stented bioprosthesis with a rigid circumferential sewing ring in the RVOT that has an internal diameter greater than or equal to 18 mm and less than or equal to 22 mm when originally implanted.
•Any of the following by transthoracic echocardiography:
•For patients in New York Heart Association (NYHA) Classification II, III, or IV: Moderate (3+) or severe (4+) pulmonary regurgitation AND/OR Mean RVOT gradient greater than or equal to 35 mmHg
•For patients in NYHA Classification I:Severe (4+) pulmonary regurgitation with RV dilatation or dysfunction AND/OR Mean RVOT gradient greater or equal to 40 mmHg

Exclusion Criteria

•Active endocarditis
•Major or progressive non-cardiac disease (liver failure, renal failure, cancer)that has a life expectancy of less than one year
•Patient or guardian unwilling or unable to provide written informed consent or comply with follow-up requirements
•Obstruction of the central veins (including the superior and inferior vena cava, bilateral iliac veins) such that the delivery system cannot be advanced to the heart via transvenous approach from either femoral vein or internal jugular vein
•Positive urine or serum pregnancy test 24 hours prior to procedure in female patients of child bearing potential
•Known intravenous drug abuse

Locations (5)

Nicklaus Children's Hospital

Miami, Florida, United States

Children's Hospital Boston

Boston, Massachusetts, United States

Children's Hospital of NY-Presbyterian

New York, New York, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Seattle Children's and Regional Hospital

Seattle, Washington, United States

Key Dates

Start Date

January 1, 2007

Primary Completion Date

May 1, 2015

Completion Date

August 21, 2020

Last Updated

March 26, 2024

Enrollment

171

ACTUAL participants

Conditions

Congenital Heart DefectsDysfunctional Right Ventricular Outflow Tract Conduits

Interventions

Transcatheter Pulmonary Valve replacement

DEVICE

Bioabsorbable Occluder for Outlet VSD: Safety and Aortic Valve Effects

NCT07040579

Congenital Heart DefectsVSD

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NOT_YET_RECRUITING

Congenital Heart Defects

NCT06124443

Congenital Heart Defects

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COMPLETED

Investigation of Cardiopulmonary Parameters, Motor Development and Muscle Strength in DS With and Without CHD

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 26, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Melody Transcatheter Pulmonary Valve Study: Post Approval Study of the Investigational Device Exemption Cohort

Inclusion Criteria

Exclusion Criteria

Bioabsorbable Occluder for Outlet VSD: Safety and Aortic Valve Effects

Congenital Heart Defects

Investigation of Cardiopulmonary Parameters, Motor Development and Muscle Strength in DS With and Without CHD

An Evaluation of Routine Developmental Follow-Up in Infants and Children With Congenital Heart Disease

Preserved Umbilical Vein Use as Autologous Shunt Conduits in Neonatal Cardiac Surgery

Exercise Training Strategies for Children With Repaired Tetralogy of Fallot