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Clinical Trials in the USA / NCT03441971
Active, not recruiting Not applicable

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

NCT03441971 · tracked via the Priya Life Science USA tracker
Sponsor
W.L.Gore & Associates
Phase
Not applicable
Started
2018-06-07
Last updated
2026-02-05

Condition(s) studied

Heart Defects, CongenitalTetralogy of FallotPulmonary Valve InsufficiencyPulmonary Valve Stenosis

Investigational drug(s) / intervention(s)

GORE PV1

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

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).

Eligibility

Sex
ALL
Min age
5 Years
Max age
—
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: 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

Primary outcome measure(s)

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

Trial sites (3)

FacilityCityRegionStatus
Lurie Children's Hospital Chicago Illinois
Boston Children's Hospital Boston Massachusetts
Nationwide Children's Hospital Columbus Ohio

More W.L.Gore & Associates trials in the USA

Long-term Characterization of GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System Performance Recruiting
Global Registry for Endovascular Aortic Treatment (GREAT) Active, not recruiting
Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms Active, not recruiting
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study Recruiting
Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis Recruiting

Other trials for the same condition

COMPASSION S3 Post-Approval Study Active, not recruiting
ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent Active, not recruiting
ALTERRA Post-Approval Study Active, not recruiting
Global Utilization And Registry Database for Improved heArt preservatioN Enrolling by invitation
Safety and Efficacy Study of reSept ASD Occluder for Treating Secundum ASD Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03441971 on ClinicalTrials.gov ↗ ← All trials in the USA