Clinical trial NCT03441971: Evaluation of the GORE PV1 Device in Patients With Pulmonary Valve Dysfunction
Official title: Evaluation of the GORE PV1 Device for Replacement of the Pulmonary Valve and Reconstruction of Right Ventricular Outflow Tract
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Heart Defects, Congenital
Tetralogy of Fallot
Pulmonary Valve Insufficiency
Pulmonary Valve Stenosis
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2018-02-22
Enrollment: 15
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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).


Eligibility criteria: 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

Primary outcomes:
measure: Valve-related mortality and device-related re-intervention
timeFrame: 6 months
Secondary outcomes:
measure: MRI change in right ventricular end diastolic volume index
timeFrame: 6 months
measure: MRI change in right ventricular end systolic volume index at 6 months
timeFrame: 6 months
measure: MRI change in left ventricular diastolic volume index at 6 months
timeFrame: 6 months
measure: MRI change in right ventricular ejection fraction at 6 months
timeFrame: 6 months
measure: Echo change in right ventricular diastolic area at 12 months
timeFrame: 12 months
measure: Echo change in right ventricular systolic area at 12 months
timeFrame: 12 months
measure: Echo change in left ventricular end diastolic volume index at 12 months
timeFrame: 12 months
measure: Echo change in right ventricular fractional area change at 12 months
timeFrame: 12 months
measure: Six month mean pressure gradient <= 40 mmHG
timeFrame: 6 months
measure: Twelve month mean pressure gradient <= 40 mmHG
timeFrame: 12 months
measure: Six month pulmonary regurgitation < moderate
timeFrame: 6 months
measure: Twelve month pulmonary regurgitation < moderate
timeFrame: 12 months
measure: Device-related re-intervention at 1, 3, 6, 12, 24, 36, 48, and 60 months
timeFrame: 1, 3, 6, 12, 24, 36, 48, and 60 months
measure: All-cause mortality at 1, 3, 6, 12, 24, 36, 48, and 60 months
timeFrame: 1, 3, 6, 12, 24, 36, 48, and 60 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Lurie Children's Hospital
state: Illinois
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Boston Children's Hospital
name: Pedro del Nido, MD
role: PRINCIPAL_INVESTIGATOR
References: