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Active, not recruitingNCT03441971Updated Feb 5, 2026

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

An interventional study of GORE PV1 in Heart Defects, Congenital, Tetralogy of Fallot and Pulmonary Valve Insufficiency, sponsored by W.L.Gore & Associates. Active, not recruiting at 3 sites in United States. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2026-02-05.

Sponsored by W.L.Gore & Associates · Not applicable, Interventional, and Device feasibility

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
5 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Heart Defects, Congenital
  • Tetralogy of Fallot
  • Pulmonary Valve Insufficiency
  • Pulmonary Valve Stenosis
03

Who can participate

Ages eligible
5 Years and older
Sexes eligible
All
Accepts 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

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

04

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Single Arm

    Participants will receive the device on Day 1.

    Device: GORE PV1

Interventions

  • DeviceGORE PV1

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

05

What researchers measure

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

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

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

    Time frame: 12 months

  7. 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

    Time frame: 12 months

  8. 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

    Time frame: 12 months

  9. 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

    Time frame: 6 months

  10. 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

    Time frame: 12 months

  11. Six month pulmonary regurgitation < moderate

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

    Time frame: 6 months

  12. Twelve month pulmonary regurgitation < moderate

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

    Time frame: 12 months

  13. 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

    Time frame: 1, 3, 6, 12, 24, 36, 48, and 60 months

  14. 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

    Time frame: 1, 3, 6, 12, 24, 36, 48, and 60 months

06

Study locations

3 sites
  • Lurie Children's Hospital
    Chicago, Illinois 60611, United States
  • Boston Children's Hospital
    Boston, Massachusetts 02115, United States
  • Nationwide Children's Hospital
    Columbus, Ohio 43205, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03441971
Lead sponsor
W.L.Gore & Associates
Responsible party
Sponsor
First posted
Feb 22, 2018
Start date
Jun 7, 2018
Primary completion
Apr 13, 2020
Completion
Mar 2030 (estimated)
Last update
Feb 5, 2026

Study contacts

Pedro del Nido, MD
principal investigator · Boston Children's Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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