Current Environment:

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.

Conditions

Congenital Heart Defects, Dysfunctional Right Ventricular Outflow Tract Conduits

Recruitment Status

Completed

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 Criteria

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

Intervention

Intervention Type

Intervention Name

Device

Transcatheter Pulmonary Valve replacement

Phase

Not Applicable

Gender

All

Minimum Age

5 Years

Maximum Age

N/A

Download Date

April 13, 2021

Principal Investigator

N/A

Primary Contact Information

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team: