Encore PFO Closure Device for Patent Foramen Ovale

Recruiting at 7 trial locations

Overseen By Joseph Marino

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Encore Medical Inc.

Must not be taking: Anticoagulants, Aspirin, Clopidogrel

Disqualifiers: Age, Hypertension, Diabetes, Atrial fibrillation, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, the Encore PFO closure device, to determine its safety and effectiveness compared to other FDA-approved devices. It targets individuals with a patent foramen ovale (PFO), a heart defect where a hole fails to close after birth, who have experienced an unexplained stroke within the last nine months. Participants must have this heart condition confirmed by a test and have had a recent stroke. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future treatment options.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have a hypercoagulable disorder requiring anticoagulation therapy or a contraindication to aspirin or clopidogrel, you may not be eligible to participate.

What prior data suggests that the Encore PFO closure device is safe for patent foramen ovale closure?

Research shows that the Encore PFO closure device is designed to be safe and effective. Early tests revealed no breaks or separations in the device, suggesting dependability in use. However, more long-term studies are needed to fully confirm its safety in people.

Additionally, data from similar devices used to close a hole in the heart for stroke prevention have generally shown these procedures to be safe and effective. This provides context for the potential safety of the Encore device, as it aims for similar results. Remember, each device and study can have different outcomes, so discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Encore PFO closure device because it offers a potentially more effective method to treat Patent Foramen Ovale (PFO), a heart condition that can lead to strokes. Unlike standard PFO closure devices, the Encore device might provide improved sealing capabilities and a more streamlined implantation process, which could reduce procedure time and increase patient comfort. Additionally, its design may allow for better adaptability to various heart anatomies, improving outcomes for a wider range of patients. These features make the Encore device a promising option in the field of PFO treatment.

What evidence suggests that the Encore PFO closure device is effective for patent foramen ovale?

Research has shown that the Encore PFO closure device, which participants in this trial may receive, safely and effectively closes a patent foramen ovale (PFO), a small hole in the heart. This trial will compare the Encore device to any FDA-approved PFO closure device, such as the Amplatzer PFO Occluder, which studies have found to be effective and safe in real-world use. The Encore device is a new option, and early results suggest it is slim and removable if needed. These features may make it a promising choice for patients requiring PFO closure. ^{2 3 6 7 8}

Who Is on the Research Team?

Christopher D Nielsen, MD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

Adults aged 18-60 with a recent cryptogenic stroke and diagnosed Patent Foramen Ovale (PFO) can join. They must have had a stroke within the last 270 days confirmed by MRI or CT, without other known causes of stroke, no severe heart issues, uncontrolled blood pressure or diabetes, clotting disorders, nickel allergy, or severe kidney/liver disease.

Inclusion Criteria

I had a stroke with unknown cause in the last 270 days, confirmed by MRI or CT.

You have a heart condition where there is a hole between the left and right atrium that causes blood to flow in the wrong direction.

Exclusion Criteria

I have a blood clot or tumor in my heart.

My kidney function is very low or I am on dialysis.

My heart has a weakened or bulging area.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Encore PFO closure device or any FDA-approved PFO closure device

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Encore PFO closure device
• FDA-approved PFO closure device

Trial Overview The trial is testing the safety and effectiveness of the Encore PFO closure device compared to any FDA-approved PFO closure device for preventing strokes in people with PFO. Participants will be randomly assigned to receive either the Encore device or another approved device.

How Is the Trial Designed?

Group I: Encore PFO closure device Experimental Treatment 1 Intervention

Group II: Any FDA-approved PFO closure device chosen by the investigator Active Control 1 Intervention

Who Is Running the Clinical Trial?

Encore Medical Inc.

Lead Sponsor

Trials

1

Recruited

500+

Bright Research Partners

Industry Sponsor

Trials

18

Recruited

2,700+

Yale Cardiovascular Research Group

Collaborator

Trials

11

Recruited

4,000+

Published Research Related to This Trial

In a study of 50 patients undergoing transcatheter closure of patent foramen ovale (PFO) using the Amplatzer device, the procedure was successful in 49 cases, demonstrating immediate effectiveness in preventing paradoxical emboli with no major complications related to the device.

At a mean follow-up of 16.5 months, there were no deaths or recurrent embolic events, indicating that PFO closure is a safe and effective alternative to anticoagulation therapy for patients with a history of ischemic stroke or transient ischemic attacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter closure of patent foramen ovale associated with paradoxical embolism using the amplatzer PFO occluder: initial and intermediate-term results of the U.S. multicenter clinical trial. Hong, TE., Thaler, D., Brorson, J., et al.[2012]

The second-generation Encore PFO closure device was successfully implanted in six swine, demonstrating good safety and feasibility over a 140-day period, with no complications such as thrombus formation or device dislodgment.

Post-implantation evaluations showed complete integration of the device into the heart tissue and favorable biocompatibility, indicating that the design modifications, including reduced metal mass, did not compromise the device's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance, safety, and biocompatibility of a novel PFO closure device in a long-term porcine model. Kachel, M., Melo, P., Van Wygerden, K., et al.[2023]

In a study involving 267 patients across 23 centers, the Premere™ PFO closure device demonstrated effective closure of patent foramen ovale (PFO), with 71% of patients showing no residual shunt after implantation.

The study reported no occurrences of stroke or transient ischemic attack (TIA) during an average follow-up of 11 months, indicating a strong safety profile for the device in patients with a history of stroke or TIA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PFO closuRE and CryptogenIc StrokE (PRECISE) registry: a multi-center, international registry. Wöhrle, J., Bertrand, B., Søndergaard, L., et al.[2021]

The study found that using the Amplatzer device for PFO closure, combined with medical therapy, is cost-effective, providing an additional 0.16 quality-adjusted life years (QALYs) at an incremental cost of 7301€, resulting in an incremental cost-effectiveness ratio (ICER) of 46,288€/QALY compared to medical therapy alone.

In patients with atrial septal aneurysm or a large shunt, the Amplatzer device plus medical therapy yielded even better results, with an additional 0.20 QALYs at a lower incremental cost of 5818€, leading to an ICER of 28,624€/QALY, and significantly reduced the number of recurrent strokes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness analysis of patent foramen ovale closure with Amplatzer plus medical therapy compared to medical therapy in patients with a history of stroke in France. Allou, A., Baschet, L., Sabourin, C., et al.[2022]

In a study of 817 patients who underwent patent foramen ovale (PFO) closure, the 5-year risk of developing atrial fibrillation (AF) was found to be 7.8%, which is higher than the 3.1% risk in those diagnosed with PFO but not closed, and 1.2% in a matched general population cohort.

While there is a significant short-term risk of AF following PFO closure (HR of 51 in the first 3 months compared to the general population), the long-term risk appears to be similar to that of individuals with a PFO diagnosis, indicating that the procedure does not substantially increase long-term AF risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term risk of atrial fibrillation or flutter after transcatheter patent foramen ovale closure: a nationwide Danish study. Skibsted, CV., Korsholm, K., Pedersen, L., et al.[2023]

Citations

1. clinicaltrial.be clinicaltrial.be/en/details/262847?per_page=100&only_recruiting=0&only_eligible=0

Encore PFO Closure Device - The PerFOrm Trial This is a prospective, multicenter, randomized clinical study to determine the safety and effectiveness of the Encore PFO closure device, ...

2. journal-of-cardiology.com journal-of-cardiology.com/article/S0914-5087(23)00223-X/fulltext

Performance, safety, and biocompatibility of a novel PFO ... The aim of the study was to evaluate the feasibility and safety of a novel low-profile, fully retrievable, Encore PFO closure device in the animal model.

3. trialx.com trialx.com/clinical-trials/listings/253632/encore-pfo-closure-device-the-perform-trial/

Encore PFO Closure Device - The PerFOrm Trial The objective of this study is to establish reasonable assurance of safety, effectiveness, and noninferiority of the Encore PFO closure device ...

4. app.trialscreen.org app.trialscreen.org/trials/patent-foramen-ovale-encore-pfo-closure-device-perform-trial-nct05537753

Encore PFO Closure Device - The PerFOrm Trial The primary goal of this study is to determine if the Encore PFO closure device is safe and effective in closing a patent foramen ovale (PFO) in patients who ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36165815/

Real world long-term outcomes among adults undergoing ... We observed excellent safety and effectiveness outcomes for PFO closure conducted with Amplatzer PFO Occluder, similar to randomized controlled trials.

6. sciencedirect.com sciencedirect.com/science/article/pii/S091450872300223X

Performance, safety, and biocompatibility of a novel PFO ... The Encore PFO Closure Device implants showed no fractures or disconnections in our preclinical study, although the long-term clinical data would be necessary ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37684005/

Performance, safety, and biocompatibility of a novel PFO ... The aim of the study was to evaluate the feasibility and safety of a novel low-profile, fully retrievable, Encore PFO closure device in the ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5699514/

Safety Outcomes After Percutaneous Transcatheter ... Observational data suggest that percutaneous transcatheter closure of PFO for secondary stroke prevention is safe and effective; however, three recent ...