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Prosthetic Device

GORE PV1 Device for Pulmonary Valve Dysfunction

N/A

Waitlist Available

Led By Pedro del Nido, MD

Research Sponsored by W.L.Gore & Associates

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥5 years at the time of informed consent signature.

A symptomatic or appropriate asymptomatic subject with a native or repaired right ventricular outflow tract requiring reconstruction with a valved conduit

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1, 3, 6, 12, 24, 36, 48, and 60 months

Awards & highlights

Study Summary

This trial will study whether the GORE PV1 Device is safe and works well to replace a diseased pulmonary valve and reconstruct the right ventricular outflow tract.

Who is the study for?

This trial is for individuals aged 5 or older with a congenital heart defect requiring pulmonary valve replacement or RVOT reconstruction. It's not suitable for those with artificial valves elsewhere, pacemakers, or severe non-cardiac diseases like liver failure, renal failure, or cancer with a life expectancy under one year.Check my eligibility

What is being tested?

The GORE PV1 Device is being tested in this study to see if it's safe and effective for replacing the pulmonary valve and reconstructing the Right Ventricular Outflow Tract (RVOT) in patients with certain heart conditions.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may include complications related to device implantation such as infection, bleeding, arrhythmia, or issues specific to heart valve devices like clotting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 5 years old or older.

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I need surgery for a heart valve issue due to symptoms or a doctor's advice.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1, 3, 6, 12, 24, 36, 48, and 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1, 3, 6, 12, 24, 36, 48, and 60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 3, 6, 12, 24, 36, 48, and 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Valve-related mortality and device-related re-intervention

Secondary outcome measures

All-cause mortality at 1, 3, 6, 12, 24, 36, 48, and 60 months

Device-related re-intervention at 1, 3, 6, 12, 24, 36, 48, and 60 months

Echo change in left ventricular end diastolic volume index at 12 months

+11 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment1 Intervention

Participants will receive the device on Day 1.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

W.L.Gore & AssociatesLead Sponsor

95 Previous Clinical Trials

28,318 Total Patients Enrolled

Pedro del Nido, MDPrincipal InvestigatorBoston Children's Hospital

Media Library

GORE PV1 (Prosthetic Device) Clinical Trial Eligibility Overview. Trial Name: NCT03441971 — N/A

Tetralogy of Fallot Research Study Groups: Single Arm

Tetralogy of Fallot Clinical Trial 2023: GORE PV1 Highlights & Side Effects. Trial Name: NCT03441971 — N/A

GORE PV1 (Prosthetic Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03441971 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings to join this research endeavor?

"According to the data on clinicaltrials.gov, this trial has ceased recruitment efforts; having initially posted on June 7th 2018 and last edited on 6/6/2022. However, 372 alternative trials are as of now actively searching for patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2018. "Evaluation of the GORE PV1 Device in Patients With Pulmonary Valve Dysfunction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03441971.