Heart Defects, Congenital, Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis, Tetralogy of Fallot
Conditions
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).
Interventions
DEVICEGORE PV1
Implantation of GORE PV1 Device for procedure to replace the pulmonary valve and reconstruct the right ventricular outflow tract (RVOT).
Sponsors
W.L.Gore & Associates
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Valve-related mortality and device-related re-intervention | 6 months | The composite of valve-related mortality and device-related re-intervention measured at 6 months post-procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MRI change in right ventricular end diastolic volume index | 6 months | Six month change from baseline in right ventricular end diastolic volume index as measured from Magnetic Resonance Imaging |
| MRI change in right ventricular end systolic volume index at 6 months | 6 months | Six month change from baseline in right ventricular end systolic volume index as measured from Magnetic Resonance Imaging |
| MRI change in left ventricular diastolic volume index at 6 months | 6 months | Six month change from baseline in left ventricular diastolic volume index as measured from Magnetic Resonance Imaging |
| MRI change in right ventricular ejection fraction at 6 months | 6 months | Six month change from baseline in right ventricular ejection fraction index as measured from Magnetic Resonance Imaging |
| Echo change in right ventricular diastolic area at 12 months | 12 months | Twelve month change from baseline in right ventricular diastolic area as measured from echocardiography |
| Echo change in right ventricular systolic area at 12 months | 12 months | Twelve month change from baseline in right ventricular systolic area as measured from echocardiography |
| Echo change in left ventricular end diastolic volume index at 12 months | 12 months | Twelve month change from baseline in left ventricular end diastolic volume index as measured from echocardiography |
| Echo change in right ventricular fractional area change at 12 months | 12 months | Twelve month change from baseline in right ventricular fractional area change as measured from echocardiography |
| Six month mean pressure gradient <= 40 mmHG | 6 months | Number of subjects with mean pressure gradient across conduit (RV to PA) less than or equal to 40 mmHg at 6 months |
| Twelve month mean pressure gradient <= 40 mmHG | 12 months | Number of subjects with mean pressure gradient across conduit (RV to PA) less than or equal to 40 mmHg at 12 months |
| Six month pulmonary regurgitation < moderate | 6 months | Number of subjects with pulmonary regurgitation less than moderate at 6 months |
| Twelve month pulmonary regurgitation < moderate | 12 months | Number of subjects with pulmonary regurgitation less than moderate at 12 months |
| Device-related re-intervention at 1, 3, 6, 12, 24, 36, 48, and 60 months | 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 |
| All-cause mortality at 1, 3, 6, 12, 24, 36, 48, and 60 months | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPedro del Nido, MD
Boston Children's Hospital
Outcome results
None listed