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

W.L. Gore & Associates

Status: Active, not recruiting

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

Treatments: Device: GORE PV1

Study type: Interventional

Funder types: Industry

Identifiers

NCT03441971

Gore PVC 17-02

Details and patient eligibility

About

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).

Enrollment: 15 estimated patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

15 participants in 1 patient group

Single Arm

Experimental group

Description:

Participants will receive the device on Day 1.

Treatment:

Device: GORE PV1