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

N/AActive Not RecruitingNCT03441971

W.L.Gore & Associates15 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

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

Interventions

GORE PV1DEVICE

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

Eligibility

Sex: ALLMin age: 5 Years

Medical Language ↔ Plain English

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

Locations (3)

Lurie Children's Hospital

Chicago, Illinois, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Outcomes

Primary Outcomes

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

Time frame: 6 months

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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