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
Among 32 studies in Tetralogy of Fallot with a site in United States — 7 open to participants now, 12 under way, none of them phase 3. Tetralogy of Fallot · United States.
Among the 32 studies in Tetralogy of Fallot with a site in United States, this one is the 17th largest by planned enrollment of the 20 interventional ones that give a count, is one of 2 that started in 2018, is one of 14 with no phase, reaches primary completion later than 0 of the 11 other live ones, and was the 20th registered.
92 studies on the registry are indexed under Tetralogy of Fallot; 25 are open to participants now.
Browse Tetralogy of Fallot studies →7 of the 32 studies in Tetralogy of Fallot with a site in United States are open now. Recruiting first, the newest first:
Boston Children's Hospital · Sites in United States
Ages 1 days–17 yrs
PECA Labs · Sites in United States
Ages 0–22
Leiden University Medical Center · Sites in United States, Germany, Netherlands and 2 more countries
Ages 18+
Weill Medical College of Cornell University · Sites in United States
Ages 30 days–100 days
Mayo Clinic · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 17 Tetralogy of Fallot studies recruiting now, 8 (47%) set no upper age limit and 9 (53%) stop at 75 or younger; 13 take children under 18; 1 takes healthy volunteers.
This study: 5 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
32 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 2 · Phase 4 1
First in 2004; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 15 is below the median of 50 across 50 interventional studies indexed under Tetralogy of Fallot.
Median enrollment 35 across the 20 interventional studies, 152 across the 12 observational. Of the 19 that completed or were terminated, 7 (37%) have results posted.
This tab as a report to print or save as PDF → With an account.
10 of 32 have an industry lead sponsor. The 10 most frequent:
W.L.Gore & Associates is the lead sponsor of 96 studies on the registry; 20 are open to participants now.
W.L.Gore & Associates has 1 study filed under Tetralogy of Fallot — fewer than ten, so there is no comparison to draw.
3 of the studies in Tetralogy of Fallot with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05077774Medtronic CardiovascularHarmony TPV Post-Approval Study | 2026-11 |
| NCT02744677Edwards LifesciencesCOMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction | 2026-12 |
| NCT07184476Boston Children's HospitalAssessment of Microvascular Circulation in the Pediatric Cardiac Surgery Patient | 2027-03-17 |
Add all 3 to your calendar (.ics) → With an account.
Among the 32 studies in Tetralogy of Fallot with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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).
92 studies on the registry are indexed under Tetralogy of Fallot; 25 are open to participants now.
This study's planned enrollment of 15 is below the median of 50 across 50 interventional studies indexed under Tetralogy of Fallot.
Browse Tetralogy of Fallot studies →W.L.Gore & Associates is the lead sponsor of 96 studies on the registry; 20 are open to participants now.
Compared within Tetralogy of Fallot, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Heart Defects, Congenital. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Note: Additional Inclusion Criteria may apply
Exclusion Criteria:
Note: Additional Exclusion Criteria may apply
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive the device on Day 1.
Device: GORE PV1
Implantation of GORE PV1 Device for procedure to replace the pulmonary valve and reconstruct the right ventricular outflow tract (RVOT).
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
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
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
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
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
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
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
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
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
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
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
Six month pulmonary regurgitation < moderate
Number of subjects with pulmonary regurgitation less than moderate at 6 months
Time frame: 6 months
Twelve month pulmonary regurgitation < moderate
Number of subjects with pulmonary regurgitation less than moderate at 12 months
Time frame: 12 months
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
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
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2018 to primary completion in Apr 2020, 22 months.
Of 25 interventional studies with no phase under Tetralogy of Fallot, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 61. This study's 22 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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