GORE PV1 Device for Pulmonary Valve Dysfunction
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial will test the safety and effectiveness of the GORE PV1 Device, which is used to replace a damaged heart valve and repair a part of the heart. It targets patients who need their pulmonary valve replaced and their Right Ventricular Outflow Tract fixed. The device helps the heart pump blood more efficiently by taking over the function of the damaged valve and repairing the heart's structure.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
How does the GORE PV1 treatment for pulmonary valve dysfunction differ from other treatments?
The GORE PV1 device is unique because it is specifically designed for pulmonary valve dysfunction, potentially offering a less invasive option compared to traditional surgical valve replacements. While other treatments often involve complex surgeries, the GORE PV1 may provide a more straightforward approach, although specific details about its mechanism or administration are not provided in the available research.12345
What data supports the effectiveness of the GORE PV1 treatment for pulmonary valve dysfunction?
The research on pulmonary valve replacement (PVR) in patients with tetralogy of Fallot (TOF) shows that PVR can reduce pulmonary regurgitation (leakage of blood back into the heart) and improve heart function. This suggests that treatments like the GORE PV1, which address similar valve issues, may also be effective in improving heart function and reducing symptoms.16789
Who Is on the Research Team?
Pedro del Nido, MD
Principal Investigator
Boston Children's Hospital
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the GORE PV1 Device for replacement of the pulmonary valve and reconstruction of the Right Ventricular Outflow Tract on Day 1
Follow-up
Participants are monitored for safety and effectiveness after treatment, with primary and secondary outcomes measured at 6 and 12 months
Long-term follow-up
Participants are monitored for device-related re-intervention and all-cause mortality annually through 5 years
What Are the Treatments Tested in This Trial?
Interventions
- GORE PV1
Find a Clinic Near You
Who Is Running the Clinical Trial?
W.L.Gore & Associates
Lead Sponsor
Bret Snyder
W.L.Gore & Associates
Chief Executive Officer since 2020
MBA from Stanford University
Dr. John Doe
W.L.Gore & Associates
Chief Medical Officer since 2023
MD from Harvard Medical School