Encore PFO Closure Device for Patent Foramen Ovale

Recruiting at7 trial locations

Overseen by Christopher D Nielsen, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Encore Medical Inc.

Must not be taking: Anticoagulants, Aspirin, Clopidogrel

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

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial tests the safety and effectiveness of the Encore PFO closure device, which is used to close a small hole in the heart. It targets patients who have had strokes with no clear cause, likely due to blood clots passing through this hole. The device is inserted through a thin tube, avoiding the need for open-heart surgery.

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.

How is the Encore PFO Closure Device treatment different from other treatments for patent foramen ovale?

The Encore PFO Closure Device is unique because it features an articulating frame structure that allows it to better fit the heart's anatomy, has a lower profile with reduced metal mass, and is fully retrievable during the procedure, addressing limitations of earlier devices like bulkiness and risk of dislodgment. ^{1 2 3 4 5}

Research Team

Christopher D Nielsen, MD

Principal Investigator

Medical University of South Carolina

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Encore PFO closure device (PFO Closure Device)
• FDA-approved PFO closure device (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.

Participant Groups

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+

Findings from Research

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 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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Performance, safety, and biocompatibility of a novel PFO closure device in a long-term porcine model. [2023]

2. United States 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. [2012]

3. Germany pubmed.ncbi.nlm.nih.gov

PFO closuRE and CryptogenIc StrokE (PRECISE) registry: a multi-center, international registry. [2021]

4. Netherlands 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. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Long-term risk of atrial fibrillation or flutter after transcatheter patent foramen ovale closure: a nationwide Danish study. [2023]