Heart Defects, Congenital Clinical Trial
Official title:
Evaluation of the GORE PV1 Device for Replacement of the Pulmonary Valve and Reconstruction of Right Ventricular Outflow Tract
Verified date | February 2024 |
Source | W.L.Gore & Associates |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Active, not recruiting |
Enrollment | 15 |
Est. completion date | March 2025 |
Est. primary completion date | April 13, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Boston Children's Hospital | Boston | Massachusetts |
United States | Lurie Children's Hospital | Chicago | Illinois |
United States | Nationwide Children's Hospital | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
W.L.Gore & Associates |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | 6 months | |
Secondary | 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 | 6 months | |
Secondary | 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 | 6 months | |
Secondary | 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 | 6 months | |
Secondary | Echo change in right ventricular diastolic area at 12 months | Twelve month change from baseline in right ventricular diastolic area as measured from echocardiography | 12 months | |
Secondary | Echo change in right ventricular systolic area at 12 months | Twelve month change from baseline in right ventricular systolic area as measured from echocardiography | 12 months | |
Secondary | Echo change in left ventricular end diastolic volume index at 12 months | Twelve month change from baseline in left ventricular end diastolic volume index as measured from echocardiography | 12 months | |
Secondary | Echo change in right ventricular fractional area change at 12 months | Twelve month change from baseline in right ventricular fractional area change as measured from echocardiography | 12 months | |
Secondary | Six month mean pressure gradient <= 40 mmHG | Number of subjects with mean pressure gradient across conduit (RV to PA) less than or equal to 40 mmHg at 6 months | 6 months | |
Secondary | Twelve month mean pressure gradient <= 40 mmHG | Number of subjects with mean pressure gradient across conduit (RV to PA) less than or equal to 40 mmHg at 12 months | 12 months | |
Secondary | Six month pulmonary regurgitation < moderate | Number of subjects with pulmonary regurgitation less than moderate at 6 months | 6 months | |
Secondary | Twelve month pulmonary regurgitation < moderate | Number of subjects with pulmonary regurgitation less than moderate at 12 months | 12 months | |
Secondary | Device-related re-intervention at 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 | 1, 3, 6, 12, 24, 36, 48, and 60 months | |
Secondary | All-cause mortality at 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 | 1, 3, 6, 12, 24, 36, 48, and 60 months |
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