This trial is active, not recruiting.

Conditions complex congenital heart defect, dysfunctional rvot conduits
Treatment transcatheter pulmonary valve replacement
Sponsor Medtronic Heart Valves
Start date January 2007
End date May 2015
Trial size 150 participants
Trial identifier NCT00740870, G050186


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 assess safety, procedural success, and clinical utility of transcatheter implantation of the Melody TPV.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Melody Transcatheter Pulmonary Valve implanted into a dysfunctional RV-PA Conduit.
transcatheter pulmonary valve replacement Melody Transcatheter Pulmonary Valve
Transcatheter valve implantation into a RV-PA conduit in patients with complex congenital heart defects where the conduit has become dysfunctional and where the patient needs invasive intervention.

Primary Outcomes

Long-Term Functionality of Melody
time frame: Five years

Secondary Outcomes

Percent of Subjects with Procedural Success
time frame: 10 years
Procedural Adverse Events
time frame: 10 years
Serious Device-related Adverse Events
time frame: 10 years
Stent fracture
time frame: 10 years
Catheter Re-intervention on TPV
time frame: 10 years
Surgical Replacement of the RVOT Conduit
time frame: 10 years
Death (all-cause, procedural and device-related)
time frame: 10 years
Functional Assessment (NYHA Classification)
time frame: 10 years

Eligibility Criteria

Male or female participants from 5 years up to 80 years old.

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 16mm 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 18mm and less than or equal to 22mm when originally implanted. - Any of the following by transthoracic echocardiography: - Patient in NYHA Classification II, III, or IV: - Moderate (3+) or severe (4+) pulmonary regurgitation - Mean RVOT gradient greater than or equal to 35mmHg - Patients in NYHA Classification I: - Severe (4+) pulmonary regurgitation with RV dilatation or dysfunction - Mean RVOT gradient greater or equal to 40mmHg 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

Additional Information

Official title Implantation of the Medtronic Melody Transcatheter Pulmonary Valve in Patients With Dysfunctional RVOT Conduits: A Feasibility Study
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Medtronic Cardiovascular.