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Heart Defects, CongenitalNCT03441971

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

A study testing GORE PV1 in people with Heart Defects, Congenital and Tetralogy of Fallot, run by W.L.Gore & Associates at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 5 years and older
What is being tested?
GORE PV1
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
3 sitesUnited States
Study dates
7 Jun 2018to Mar 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Boston Children's Hospital

    Boston, Massachusetts, 02115

  • Lurie Children's Hospital

    Chicago, Illinois, 60611

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

Other trials in United States

About this study

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

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).

Being tested
GORE PV1
Medical subject headings
Heart Defects, Congenital, Tetralogy of Fallot, Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GORE PV1Device

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

Study groups in NCT03441971
Study groupRoleWhat they receive
Single ArmExperimentalParticipants will receive the device on Day 1.
Receives: Device: GORE PV1

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 months

Secondary outcomes (14)

  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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 12 months

  11. Six month pulmonary regurgitation < moderate

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

    Measured: 6 months

  12. Twelve month pulmonary regurgitation < moderate

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

    Measured: 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

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2018
  2. Study start7 Jun 2018
  3. Primary completion13 Apr 2020
  4. Study completionMar 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03441971
Sponsor's protocol ID
Gore PVC 17-02
Status last verified
Feb 2026
First submitted
15 Feb 2018
Last updated
5 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing GORE PV1 in people with Heart Defects, Congenital and Tetralogy of Fallot, run by W.L.Gore & Associates at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Valve-related mortality and device-related re-intervention (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03441971.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.

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