GORE PV1 Device for Pulmonary Valve Dysfunction

Recruiting at 2 trial locations

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: W.L.Gore & Associates

Disqualifiers: Artificial valve, Pacemaker, Liver failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 1 day

15 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 6 7 8 9}

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.

Research Team

Pedro del Nido, MD

Principal Investigator

Boston Children's Hospital

Eligibility Criteria

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

I am 5 years old or older.

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

Exclusion Criteria

You have a pacemaker or defibrillator implanted in your body.

I do not have a major illness with a life expectancy of less than one year.

I have or will need an artificial valve replacement soon.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the GORE PV1 Device for replacement of the pulmonary valve and reconstruction of the Right Ventricular Outflow Tract on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with primary and secondary outcomes measured at 6 and 12 months

12 months

Multiple visits (in-person and virtual) 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

5 years

Treatment Details

Interventions

• GORE PV1

Trial Overview 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.

Participant Groups

Group I: Single Arm Experimental Treatment 1 Intervention

Participants will receive the device on Day 1.

Who Is Running the Clinical Trial?

W.L.Gore & Associates

Lead Sponsor

Trials

103

Recruited

32,900+

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

References

1. Germany pubmed.ncbi.nlm.nih.gov

Long-term results of pulmonary valve annular enlargement with valve repair in tetralogy of Fallot. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Pulmonary valve replacement in tetralogy of Fallot: impact on survival and ventricular tachycardia. [2022]

3. Iran pubmed.ncbi.nlm.nih.gov

The Effect of Pulmonary Valve Replacement (PVR) Surgery on Hemodynamics of Patients Who Underwent Repair of Tetralogy of Fallot (TOF). [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Pulmonary valve replacement after tetralogy of Fallot repair in preadolescent patients. [2010]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Impact of pulmonary valve replacement in tetralogy of Fallot with pulmonary regurgitation: a comparison of intervention and nonintervention. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Mid- to long-term follow-up of pulmonary valve replacement with BioIntegral injectable valve. [2020]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Expanding the indications for pulmonary valve replacement after repair of tetralogy of fallot. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Late pulmonary valve replacement in patients with pulmonary atresia and intact ventricular septum: a case-matched study. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Outcomes of pulmonary valve replacement using a bioprosthetic valve and polytetrafluoroethylene bicuspid valve for pulmonary valve regurgitation after intracardiac repair of tetralogy of Fallot. [2021]