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NCT Number: NCT03441971

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

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Diseases Heart Valve Diseases Pulmonary Valve Insufficiency Pulmonary Valve Stenosis Tetralogy of Fallot Ventricular Outflow Obstruction

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lurie Children's Hospital, Chicago, Illinois, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A symptomatic or appropriate asymptomatic subject with a native or repaired right ventricular outflow tract requiring reconstruction with a valved conduit
  • Age ≥5 years at the time of informed consent signature.

Note: Additional Inclusion Criteria may apply

Exclusion criteria

  • 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).
  • Subjects with previously implanted pacemaker (including defibrillators).
  • 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

Treatment and study plan

GORE PV1

Device

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

Primary outcomes

  1. Valve-related mortality and device-related re-intervention

    Time frame: 6 months

    The composite of valve-related mortality and device-related re-intervention measured at 6 months post-procedure

Secondary outcomes

  1. MRI change in right ventricular end diastolic volume index

    Time frame: 6 months

    Six month change from baseline in right ventricular end diastolic volume index as measured from Magnetic Resonance Imaging

  2. MRI change in right ventricular end systolic volume index at 6 months

    Time frame: 6 months

    Six month change from baseline in right ventricular end systolic volume index as measured from Magnetic Resonance Imaging

  3. MRI change in left ventricular diastolic volume index at 6 months

    Time frame: 6 months

    Six month change from baseline in left ventricular diastolic volume index as measured from Magnetic Resonance Imaging

  4. MRI change in right ventricular ejection fraction at 6 months

    Time frame: 6 months

    Six month change from baseline in right ventricular ejection fraction index as measured from Magnetic Resonance Imaging

  5. Echo change in right ventricular diastolic area at 12 months

    Time frame: 12 months

    Twelve month change from baseline in right ventricular diastolic area as measured from echocardiography

  6. Echo change in right ventricular systolic area at 12 months

    Time frame: 12 months

    Twelve month change from baseline in right ventricular systolic area as measured from echocardiography

  7. Echo change in left ventricular end diastolic volume index at 12 months

    Time frame: 12 months

    Twelve month change from baseline in left ventricular end diastolic volume index as measured from echocardiography

  8. Echo change in right ventricular fractional area change at 12 months

    Time frame: 12 months

    Twelve month change from baseline in right ventricular fractional area change as measured from echocardiography

  9. Six month mean pressure gradient <= 40 mmHG

    Time frame: 6 months

    Number of subjects with mean pressure gradient across conduit (RV to PA) less than or equal to 40 mmHg at 6 months

  10. Twelve month mean pressure gradient <= 40 mmHG

    Time frame: 12 months

    Number of subjects with mean pressure gradient across conduit (RV to PA) less than or equal to 40 mmHg at 12 months

  11. Six month pulmonary regurgitation < moderate

    Time frame: 6 months

    Number of subjects with pulmonary regurgitation less than moderate at 6 months

  12. Twelve month pulmonary regurgitation < moderate

    Time frame: 12 months

    Number of subjects with pulmonary regurgitation less than moderate at 12 months

  13. Device-related re-intervention at 1, 3, 6, 12, 24, 36, 48, and 60 months

    Time frame: 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

  14. All-cause mortality at 1, 3, 6, 12, 24, 36, 48, and 60 months

    Time frame: 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

Sponsors and collaborators

Lead sponsor

W.L.Gore & Associates

Industry

Registry information

Official study title

Evaluation of the GORE PV1 Device for Replacement of the Pulmonary Valve and Reconstruction of Right Ventricular Outflow Tract

Important dates

Study start
2018
Primary completion
2020
Study completion
2030
First posted
Feb 22, 2018
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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