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

NCT03441971 | Active Not Recruiting DMC FDA Device

• 1 other identifier: Gore PVC 17-02
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 3

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).

Conditions

Heart Defects, Congenital; Tetralogy of Fallot; Pulmonary Valve Insufficiency; Pulmonary Valve Stenosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• MRI change in right ventricular end diastolic volume index

  6 months

• MRI change in right ventricular end systolic volume index at 6 months

  6 months

• MRI change in left ventricular diastolic volume index at 6 months

  6 months

• MRI change in right ventricular ejection fraction at 6 months

  6 months

• Echo change in right ventricular diastolic area at 12 months

  12 months

Study Arms (1)

Single Arm

EXPERIMENTAL

Participants will receive the device on Day 1.

Device: GORE PV1

Interventions

GORE PV1 DEVICE

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

Single Arm

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• A symptomatic or appropriate asymptomatic subject with a native or repaired right ventricular outflow tract requiring reconstruction with a valved conduit
• Age ≥5 years at the time of informed consent signature.

You may not qualify if:

• 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).
• Subjects with previously implanted pacemaker (including defibrillators).
• Major or progressive non-cardiac disease (liver failure, renal failure, cancer) that has a life expectancy of less than one year.

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Study Sites (3)

Lurie Children's Hospital

Chicago, Illinois, 60611, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital; Tetralogy of Fallot; Pulmonary Valve Insufficiency; Pulmonary Valve Stenosis

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Valve Diseases; Ventricular Outflow Obstruction

Study Officials

• Pedro del Nido, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: February 22, 2018
• Study Start: June 7, 2018
• Primary Completion: April 13, 2020
• Study Completion (Estimated): March 1, 2030
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)