GORE PV1 Device for Pulmonary Valve Dysfunction

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of the GORE PV1 Device, a medical device for heart valve replacement, in addressing issues with the pulmonary valve and the right ventricular outflow tract (the path blood takes from the heart to the lungs). It targets individuals with symptoms or conditions affecting this heart area. Participants will receive the device on the first day of the trial. Ideal candidates have experienced issues with the heart's right side and require a new valve to improve blood flow. This trial excludes those who already have or will soon need another artificial heart valve or have a pacemaker. As an unphased trial, it offers a unique opportunity to contribute to medical research and potentially benefit from a novel treatment.

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 prior data suggests that the GORE PV1 Device is safe for pulmonary valve replacement?

Research has shown that the GORE PV1 device is likely safe. Early studies tested this device for replacing the pulmonary valve and rebuilding the Right Ventricular Outflow Tract (RVOT). These studies, conducted at several locations, focused on patient responses to the device.

Initial results are positive, with no major safety issues identified. Researchers observed a group of patients who received the GORE PV1 device and monitored for any unwanted side effects. So far, the device appears safe for humans, and patients generally tolerate it well.

Overall, evidence suggests that the GORE PV1 device is a safe option for those needing pulmonary valve replacement and RVOT reconstruction. Confidence in the treatment's safety is crucial when considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The GORE PV1 device is unique because it offers a novel approach to treating pulmonary valve dysfunction. Unlike traditional surgical valve replacement or repair, which can be invasive and require significant recovery time, the GORE PV1 is a minimally invasive device. This means it can be delivered through a catheter, reducing the need for open-heart surgery and potentially speeding up recovery. Researchers are excited about this treatment because it could provide a safer and more efficient option for patients, with the possibility of fewer complications and shorter hospital stays.

What evidence suggests that the GORE PV1 Device is effective for pulmonary valve dysfunction?

Research has shown that the GORE PV1 Device holds promise for treating pulmonary valve issues in the heart. Early studies found that this device, made from expanded polytetrafluoroethylene, functions effectively as a new valve. Patients experienced good valve function without major issues like blood clots. Heart ultrasound scans before and after surgery demonstrated improved blood flow through the valve. Initial results also suggest positive outcomes in patient care with this device. Overall, these findings indicate that the GORE PV1 Device could effectively address heart valve problems. ^{1 2 4 5 6}

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. annalsthoracicsurgery.org annalsthoracicsurgery.org/article/S0003-4975(21)01981-0/fulltext

Preliminary Results With a Novel Expanded ... This preliminary evaluation of a novel expanded polytetrafluoroethylene–based valved conduit suggests promising valve function with no thromboembolic or ...

2. clinicaltrial.be clinicaltrial.be/en/details/7681?per_page=100&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Evaluation of the GORE PV1 Device in Patients With ... This study will assess the safety and performance of the GORE PV1 Device for replacement of the pulmonary valve and reconstruction of the ...

3. annalsthoracicsurgery.org annalsthoracicsurgery.org/article/S0003-4975(21)01981-0/pdf

Preliminary Results With a Novel Expanded ... (B) Pulmonary valve and GORE PV1 device mean pressure gradients evaluated by echocardiogram before and after surgery. Ann Thorac Surg. 2022;114:2314-22. BAIRD ...

4. nature.com nature.com/articles/s41598-024-82336-4

Mid-term outcomes of percutaneous pulmonary valve ... This study assesses mid-term outcomes in 76 patients who underwent PPVR between 2016 and 2022, comparing native (40.8%) and non-native (59.2%) RVOTs.

5. goremedical.com goremedical.com/en-emea/about-us/news/novel-biosynthetic-tissue-valve-six-month-results-2020-11-18

Gore announces encouraging 6-Month Results with ... The early study results on Gore's biosynthetic tissue valve presented at the AHA indicate encouraging outcomes for patient care.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003497521019810

Preliminary Results With a Novel Expanded ... This was a prospective, multicenter, single-arm study evaluating safety ... GORE PV1 device for replacement of the pulmonary valve and reconstruction of the RVOT.