Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03441971 · ClinicalTrials.gov registry record · NA
Evaluation of the GORE PV1 Device in Patients With Pulmonary Valve Dysfunction
A NA study of Heart Defects, Congenital and Tetralogy of Fallot, sponsored by W.L.Gore & Associates.
- Active
- Registry status
- NA
- Development phase
- 15
- Enrollment target
- 3
- Study locations
NCT03441971: Active NA study of Heart Defects, Congenital and Tetralogy of Fallot, sponsored by W.L.Gore & Associates.
NCT03441971 is a NA study of Heart Defects, Congenital and Tetralogy of Fallot that is active but no longer recruiting, run by W.L.Gore & Associates. The registered enrollment target is 15 participants, below the 362-participant average among 9 other Heart Defects, Congenital trials with a reported enrollment target (96% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03441971, a NA study of Heart Defects, Congenital and Tetralogy of Fallot, is active but no longer recruiting, sponsored by W.L.Gore & Associates.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
- 3
- Study locations
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).
Primary Outcome
The composite of valve-related mortality and device-related re-intervention measured at 6 months post-procedure
Conditions Studied
Interventions
- DEVICE GORE PV1
Study Locations (3)
Illinois
- Lurie Children's Hospital - Chicago
Massachusetts
- Boston Children's Hospital - Boston
Ohio
- Nationwide Children's Hospital - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2018-06-07 |
| Est. Completion | 2030-03 |
| Phase | NA |
What the registry record for NCT03441971 still lists
NCT03441971 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 362-participant average among 9 other Heart Defects, Congenital trials with a reported enrollment target (96% lower).
The record links to 4 conditions, with Heart Defects, Congenital appearing as the primary indexed condition, and to 1 intervention - of which GORE PV1 is the first listed.
NCT03441971 reports a single indexed study location in Illinois, Massachusetts, Ohio.
Frequently Asked Questions
What is clinical trial NCT03441971 about?
NCT03441971 is a clinical study titled "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).
What is the current status of trial NCT03441971?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 15 participants. The study started on 2018-06-07. Estimated completion is 2030-03.
What conditions does trial NCT03441971 study?
This clinical trial studies the following conditions: Heart Defects, Congenital, Tetralogy of Fallot, Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis.
What interventions are being tested in trial NCT03441971?
The interventions under investigation include: GORE PV1 (DEVICE).
Who is sponsoring clinical trial NCT03441971?
This trial is sponsored by W.L.Gore & Associates, which has 53 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03441971 being conducted?
This trial has 3 study locations across Illinois, Massachusetts, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Heart Defects, Congenital
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03441971's enrollment target sits among peer trials
15 10th of 9 the lowest of 9 other Heart Defects, Congenital trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Defects, Congenital trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
HeartGPS: A Study Exploring the Effects of a Psychological Intervention for Parents and Their Babies After Prenatal Cardiac Diagnosis
RECRUITING · NA
-
Congenital Heart Disease Physical Activity Lifestyle Study V.2
RECRUITING · NA
-
Safety and Efficacy Study of reSept ASD Occluder for Treating Secundum ASD
ACTIVE NOT RECRUITING · NA
-
Tuning in to Kids: An Online, Group Program Tailored for Parents of Children With Congenital Heart Disease
COMPLETED · NA
-
SPECS: Safe Pediatric Euglycemia in Cardiac Surgery
COMPLETED · NA
-
Parent Communication for Feeding an Infant With a Heart Defect
COMPLETED · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01889381 · 15 participants · Phase 2
Human Craniomaxillofacial Allotransplantation
- NCT02530073 · 15 participants · NA
Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH
- NCT02535936 · 15 participants · NA
Cortical Plasticity in Spastic Diplegia After Selective Dorsal Rhizotomy
- NCT02918474 · 15 participants · NA
Decision Making Tool in Supporting Decision Making in Contralateral Prophylactic Mastectomy in Patients With Newly Diagnosed Breast Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI