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

Not Applicable

Completed

Conditions: Dysfunctional Right Ventricular Outflow Tract Conduits
Congenital Heart Defects

Interventions: Device: Transcatheter Pulmonary Valve replacement

Registration Number: NCT00740870

Lead Sponsor: Medtronic Cardiovascular

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 171

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Melody TPV Implant	Transcatheter Pulmonary Valve replacement	Melody Transcatheter Pulmonary Valve implanted into a dysfunctional RVOT Conduit.

Primary Outcome Measures

Name	Time	Method
Kaplan-Meier Freedom From TPV Dysfunction	5 years	To assess whether long-term functionality of implantation of the Medtronic Melody TPV at 5 years is no worse than the historical control established through literature review. This study is designed to test the null hypothesis that the true freedom from TPV dysfunction at 5 years after Melody implantation (PMelody) is less than or equal to 36% (PControl). To reject the null hypothesis means that freedom from TPV dysfunction at 5 years after Melody implantation (PMelody) is greater than 36% (PControl). The null (H0) and alternative (HA) hypotheses are written as follows:H0: PMelody ≤ PControl and HA: PMelody \> PControl. TPV dysfunction is a composite outcome defined as the following: * Hemodynamic dysfunction of the TPV * Moderate or greater pulmonary regurgitation, and/or * Mean Right Ventricular Outflow Tract (RVOT) gradient greater than 40 mmHg * RVOT reoperation for conduit dysfunction or device-related reasons * Catheter re-intervention on the TPV

Secondary Outcome Measures

Name	Time	Method
Kaplan-Meier Freedom From Major Stent Fracture at 10 Years	10 years	Major stent fracture is defined as a stent fracture requiring intervention to prevent permanent impairment of a body function or permanent damage to a body structure.
Procedural Success	Within 24 Hours post implant	Procedural success is a composite outcome defined as: * Melody TPV fixated within the desired location * Right Ventricle (RV) - Pulmonary Artery (PA) peak-to-peak gradient (measured in the catheterization lab) less than 35 mmHg post-implant * Less than mild pulmonary regurgitation by angiography post-implant * Free of explant at 24 hours post-implant
Kaplan-Meier Freedom From Major Stent Fracture at 5 Years	5 years	Major stent fracture is defined as a stent fracture requiring intervention to prevent permanent impairment of a body function or permanent damage to a body structure.
Kaplan-Meier Freedom From Surgical Replacement of the RVOT Conduit	10 years	Surgical Replacement of the RVOT Conduit is defined as any surgical procedure to repair, alter, or explant the TPV
Kaplan-Meier Freedom From Death (All-cause, Procedural and Device-related)	10 years	Deaths is defined as all-cause, procedural and device-related events at 10 years
Freedom From TPV Dysfunction at 10 Years	10 years	The outcome measure for this objective is TPV dysfunction, which is a composite outcome defined as RVOT reoperation for conduit dysfunction or device-related reasons, catheter re-intervention on the TPV, or hemodynamic dysfunction of the TPV (moderate or greater pulmonary regurgitation, and/or a mean RVOT gradient greater than 40 mmHg).
Serious Procedural Adverse Event (AE)	10 years	A procedure-related event is defined as an event that is associated with the implant procedure by the chronology or physiology and was caused by the implant procedure (e.g. rupture of the conduit or damage to an intra-cardiac or intravascular structure by the delivery system).
Serious Device-related Adverse Event	10 years	A device-related event is defined as an event that is associated with the TPV by the chronology or physiology and was caused by the the TPV (e.g. embolization of the TPV and any adverse events which follow).
Kaplan-Meier Freedom From Catheter Re-intervention on TPV	10 years	Catheter Re-intervention is defined as: any catheter-based intervention involving the TPV, including balloon dilatation, stenting, or placement of a second TPV
Functional Assessment (NYHA Classification)	6 Months	Improvement in Functional Assessment (NYHA Classification) at 6 months post implant.

Trial Locations

Locations (5): Seattle Children's and Regional Hospital
🇺🇸
Seattle, Washington, United States
Nicklaus Children's Hospital
🇺🇸
Miami, Florida, United States
Children's Hospital Boston
🇺🇸
Boston, Massachusetts, United States
Nationwide Children's Hospital
🇺🇸
Columbus, Ohio, United States
Children's Hospital of NY-Presbyterian
🇺🇸
New York, New York, United States