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

Congenital Heart Defects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00740870
• Other study ID #: G050186
• Status: Completed
• Phase: N/A
• Start date: January 2007
• Est. completion date: August 21, 2020

Study information

• Verified date: March 2024
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: August 21, 2020
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Defects
• Dysfunctional Right Ventricular Outflow Tract Conduits
• Heart Defects, Congenital

Intervention

Device:
• Transcatheter Pulmonary Valve replacement
Transcatheter valve implantation into a RVOT conduit in patients with complex congenital heart defects where the conduit has become dysfunctional and where the patient needs invasive intervention.

Locations

Country	Name	City	State
United States	Children's Hospital Boston	Boston	Massachusetts
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Nicklaus Children's Hospital	Miami	Florida
United States	Children's Hospital of NY-Presbyterian	New York	New York
United States	Seattle Children's and Regional Hospital	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiovascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kaplan-Meier Freedom From TPV Dysfunction	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	5 years
Secondary	Freedom From TPV Dysfunction at 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).	10 years
Secondary	Procedural Success	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	Within 24 Hours post implant
Secondary	Serious Procedural Adverse Event (AE)	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).	5 years
Secondary	Serious Procedural Adverse Event (AE)	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).	10 years
Secondary	Serious Device-related Adverse Event	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).	5 years
Secondary	Serious Device-related Adverse Event	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).	10 years
Secondary	Kaplan-Meier Freedom From Major Stent Fracture at 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.	5 years
Secondary	Kaplan-Meier Freedom From Major Stent Fracture at 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.	10 years
Secondary	Kaplan-Meier Freedom From Catheter Re-intervention on TPV	Catheter Re-intervention is defined as: any catheter-based intervention involving the TPV, including balloon dilatation, stenting, or placement of a second TPV	5 years
Secondary	Kaplan-Meier Freedom From Catheter Re-intervention on TPV	Catheter Re-intervention is defined as: any catheter-based intervention involving the TPV, including balloon dilatation, stenting, or placement of a second TPV	10 years
Secondary	Kaplan-Meier Freedom From Surgical Replacement of the RVOT Conduit	Surgical Replacement of the RVOT Conduit is defined as any surgical procedure to repair, alter, or explant the TPV	5 years
Secondary	Kaplan-Meier Freedom From Surgical Replacement of the RVOT Conduit	Surgical Replacement of the RVOT Conduit is defined as any surgical procedure to repair, alter, or explant the TPV	10 years
Secondary	Kaplan-Meier Freedom From Death (All-cause, Procedural and Device-related)	Deaths is defined as all-cause, procedural and device-related events at 5 years	5 years
Secondary	Kaplan-Meier Freedom From Death (All-cause, Procedural and Device-related)	Deaths is defined as all-cause, procedural and device-related events at 10 years	10 years
Secondary	Functional Assessment (NYHA Classification)	Improvement in Functional Assessment (NYHA Classification) at 6 months post implant.	6 Months