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

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Defects, Congenital; Tetralogy of Fallot; Pulmonary Valve Insufficiency; Pulmonary Valve Stenosis
• Intervention / Treatment: Device: GORE PV1

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Lurie Children's Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm; Participants will receive the device on Day 1.	Device: GORE PV1; Implantation of GORE PV1 Device for procedure to replace the pulmonary valve and reconstruct the right ventricular outflow tract (RVOT).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
Six month pulmonary regurgitation < moderate	Number of subjects with pulmonary regurgitation less than moderate at 6 months	6 months
Twelve month pulmonary regurgitation < moderate	Number of subjects with pulmonary regurgitation less than moderate at 12 months	12 months
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
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

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates
• Investigators: Principal Investigator: Pedro del Nido, MD, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2018
• Primary Completion (Actual): April 13, 2020
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: February 15, 2018
• First Submitted That Met QC Criteria: February 15, 2018
• First Posted (Actual): February 22, 2018

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Cardiovascular Abnormalities; Congenital Abnormalities; Tetralogy of Fallot; Heart Defects, Congenital; Pulmonary Valve Insufficiency; Pulmonary Valve Stenosis
• Other Study ID Numbers: Gore PVC 17-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No