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

Not Applicable

Active, not recruiting

• Conditions: Tetralogy of Fallot; Pulmonary Valve Insufficiency; Heart Defects, Congenital; Pulmonary Valve Stenosis
• Interventions: Device: GORE PV1

• Registration Number: NCT03441971
• Lead Sponsor: W.L.Gore & Associates

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-15
• Study First Submitted QC: 2018-02-15
• Study First Posted: 2018-02-22
• Study Start: 2018-06-07
• Primary Completion: 2020-04-13
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-27
• Study Completion: 2030-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	GORE PV1	Participants will receive the device on Day 1.

Primary Outcome Measures

Name	Time	Method
Valve-related mortality and device-related re-intervention	6 months	The composite of valve-related mortality and device-related re-intervention measured at 6 months post-procedure

Secondary Outcome Measures

Name	Time	Method
MRI change in right ventricular end diastolic volume index	6 months	Six month change from baseline in right ventricular end diastolic volume index as measured from Magnetic Resonance Imaging
MRI change in right ventricular end systolic volume index at 6 months	6 months	Six month change from baseline in right ventricular end systolic volume index as measured from Magnetic Resonance Imaging
MRI change in left ventricular diastolic volume index at 6 months	6 months	Six month change from baseline in left ventricular diastolic volume index as measured from Magnetic Resonance Imaging
MRI change in right ventricular ejection fraction at 6 months	6 months	Six month change from baseline in right ventricular ejection fraction index as measured from Magnetic Resonance Imaging
Echo change in right ventricular diastolic area at 12 months	12 months	Twelve month change from baseline in right ventricular diastolic area as measured from echocardiography
Six month pulmonary regurgitation < moderate	6 months	Number of subjects with pulmonary regurgitation less than moderate at 6 months
Echo change in right ventricular systolic area at 12 months	12 months	Twelve month change from baseline in right ventricular systolic area as measured from echocardiography
Echo change in left ventricular end diastolic volume index at 12 months	12 months	Twelve month change from baseline in left ventricular end diastolic volume index as measured from echocardiography
Echo change in right ventricular fractional area change at 12 months	12 months	Twelve month change from baseline in right ventricular fractional area change as measured from echocardiography
Six month mean pressure gradient <= 40 mmHG	6 months	Number of subjects with mean pressure gradient across conduit (RV to PA) less than or equal to 40 mmHg at 6 months
Twelve month mean pressure gradient <= 40 mmHG	12 months	Number of subjects with mean pressure gradient across conduit (RV to PA) less than or equal to 40 mmHg at 12 months
Twelve month pulmonary regurgitation < moderate	12 months	Number of subjects with pulmonary regurgitation less than moderate at 12 months
Device-related re-intervention at 1, 3, 6, 12, 24, 36, 48, and 60 months	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
All-cause mortality at 1, 3, 6, 12, 24, 36, 48, and 60 months	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

Trial Locations

Locations (3)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States

Lurie Children's Hospital; 🇺🇸 Chicago, Illinois, United States

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States