Evaluation of the GORE PV1 Device in Patients With Pulmonary Valve Dysfunction

Heart Defects, Congenital Clinical Trial

Official title:

Evaluation of the GORE PV1 Device for Replacement of the Pulmonary Valve and Reconstruction of Right Ventricular Outflow Tract

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03441971
• Other study ID #: Gore PVC 17-02
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 7, 2018
• Est. completion date: March 2025

Study information

• Verified date: February 2024
• Source: W.L.Gore & Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will assess the safety and performance of the GORE PV1 Device for replacement of the pulmonary valve and reconstruction of the Right Ventricular Outflow Tract (RVOT).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: March 2025
• Est. primary completion date: April 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

Inclusion Criteria:

1. A symptomatic or appropriate asymptomatic subject with a native or repaired right ventricular outflow tract requiring reconstruction with a valved conduit

2. Age =5 years at the time of informed consent signature. Note: Additional Inclusion Criteria may apply

Exclusion Criteria:

1. An artificial valve at another position or will need an artificial valve at another position (i.e. replacement at the time of index procedure or anticipated within 3 years).

2. Subjects with previously implanted pacemaker (including defibrillators).

3. Major or progressive non-cardiac disease (liver failure, renal failure, cancer) that has a life expectancy of less than one year. Note: Additional Exclusion Criteria may apply

Related Conditions & MeSH terms

• Congenital Abnormalities
• Heart Defects, Congenital
• Pulmonary Valve Insufficiency
• Pulmonary Valve Stenosis
• Tetralogy of Fallot

Intervention

Device:
• GORE PV1
Implantation of GORE PV1 Device for procedure to replace the pulmonary valve and reconstruct the right ventricular outflow tract (RVOT).

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Lurie Children's Hospital	Chicago	Illinois
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Valve-related mortality and device-related re-intervention	The composite of valve-related mortality and device-related re-intervention measured at 6 months post-procedure	6 months
Secondary	MRI change in right ventricular end diastolic volume index	Six month change from baseline in right ventricular end diastolic volume index as measured from Magnetic Resonance Imaging	6 months
Secondary	MRI change in right ventricular end systolic volume index at 6 months	Six month change from baseline in right ventricular end systolic volume index as measured from Magnetic Resonance Imaging	6 months
Secondary	MRI change in left ventricular diastolic volume index at 6 months	Six month change from baseline in left ventricular diastolic volume index as measured from Magnetic Resonance Imaging	6 months
Secondary	MRI change in right ventricular ejection fraction at 6 months	Six month change from baseline in right ventricular ejection fraction index as measured from Magnetic Resonance Imaging	6 months
Secondary	Echo change in right ventricular diastolic area at 12 months	Twelve month change from baseline in right ventricular diastolic area as measured from echocardiography	12 months
Secondary	Echo change in right ventricular systolic area at 12 months	Twelve month change from baseline in right ventricular systolic area as measured from echocardiography	12 months
Secondary	Echo change in left ventricular end diastolic volume index at 12 months	Twelve month change from baseline in left ventricular end diastolic volume index as measured from echocardiography	12 months
Secondary	Echo change in right ventricular fractional area change at 12 months	Twelve month change from baseline in right ventricular fractional area change as measured from echocardiography	12 months
Secondary	Six month mean pressure gradient <= 40 mmHG	Number of subjects with mean pressure gradient across conduit (RV to PA) less than or equal to 40 mmHg at 6 months	6 months
Secondary	Twelve month mean pressure gradient <= 40 mmHG	Number of subjects with mean pressure gradient across conduit (RV to PA) less than or equal to 40 mmHg at 12 months	12 months
Secondary	Six month pulmonary regurgitation < moderate	Number of subjects with pulmonary regurgitation less than moderate at 6 months	6 months
Secondary	Twelve month pulmonary regurgitation < moderate	Number of subjects with pulmonary regurgitation less than moderate at 12 months	12 months
Secondary	Device-related re-intervention at 1, 3, 6, 12, 24, 36, 48, and 60 months	Kaplan-Meier estimates of device-related re-intervention summarized at 1, 3, 6, 12 months, and annually through 5 years	1, 3, 6, 12, 24, 36, 48, and 60 months
Secondary	All-cause mortality at 1, 3, 6, 12, 24, 36, 48, and 60 months	Kaplan-Meier estimates of all-cause mortality summarized at 1, 3, 6, 12 months, and annually through 5 years	1, 3, 6, 12, 24, 36, 48, and 60 months