What is the mechanism of action of this treatment?

The most common treatment for Patent Foramen Ovale (PFO) is physical closure, either through surgical or percutaneous methods. This procedure involves sealing the abnormal opening between the atria of the heart, which prevents the abnormal shunting of blood from the right atrium to the left atrium. By closing the PFO, the treatment aims to improve blood flow and reduce the risk of paradoxical embolism, which can lead to strokes or other complications. This is particularly important for PFO patients as it addresses the underlying cause of their symptoms and reduces the risk of future cardiovascular events.

What side effects are associated with this type of intervention?

The most common treatments for Patent Foramen Ovale (PFO) involve surgical closure, either through catheter-based techniques or open-heart surgery. Common side effects of these procedures include infection, bleeding, arrhythmias, and complications related to anesthesia. If a closure device is used, there may also be risks of device migration or erosion. These side effects are generally associated with the physical closure of abnormal heart openings to improve blood flow and reduce shunting.

What prior FDA approvals exist?

The FDA has approved several devices for the physical closure of Patent Foramen Ovale (PFO) to improve blood flow and reduce shunting. Notably, the Amplatzer PFO Occluder and the Gore Cardioform Septal Occluder are among the devices approved for this purpose. These devices are implanted via a catheter-based procedure to close the PFO, thereby preventing abnormal blood flow between the atria. These treatments are similar to those being studied in trials focusing on the surgical closure of PFO/ASD.

What other types of research exist?

Promising novel alternatives to surgical closure of PFO/ASD for Patent Foramen Ovale patients include transcatheter device closure, which is a minimally invasive procedure using a catheter to place a closure device in the heart. Additionally, advancements in medical management, such as the use of anticoagulants and antiplatelet therapy, are being explored to reduce the risk of stroke and other complications associated with PFO. These alternatives offer less invasive options with potentially lower risks and quicker recovery times compared to traditional surgery.

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Procedure

PFO Closure for Heart Hole (Patent Foramen Ovale) (PFO CLOSE Trial)

N/A

Waitlist Available

Led By Andrew Lovering, PhD

Research Sponsored by University of Oregon

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Men and women aged 18-80 undergoing PFO/ASD closure.

Be older than 18 years old

Must not have

Previous history of coronary artery disease (ischemic heart disease such as angina, heart attack, myocardial infarction).

Women who are pregnant or trying to become pregnant.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 3 months post percutaneous closure

Awards & highlights

Summary

This trial examines how closing a small hole in the heart can help patients with certain heart defects. The procedure aims to improve blood oxygen levels, reduce stroke risk, and enhance exercise capacity.

Who is the study for?

This trial is for men and women aged 18-80 who are undergoing surgical closure of a heart defect called Patent Foramen Ovale (PFO) or Atrial Septal Defect (ASD). Candidates should not be on heart or respiratory disease meds that can't be paused, nor pregnant. Those with coronary artery disease or unable to perform cycle exercise (for the exercise study group) are excluded.

What is being tested?

The study aims to understand changes in heart and lung function before and after the surgical procedure to close PFO/ASD. Participants will be assessed based on their cardiopulmonary response during exercises like cycling, as well as at rest.

What are the potential side effects?

While specific side effects aren't listed here, generally, PFO/ASD closure procedures may include risks such as bleeding, infection at the incision site, allergic reactions to medications used during surgery like Lidocaine or Heparin, and complications related to heart function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 80 years old and am having a procedure to close a hole in my heart.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had heart problems like angina or a heart attack before.

Select...

I am currently pregnant or trying to conceive.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 3 months post percutaneous closure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 3 months post percutaneous closure

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 3 months post percutaneous closure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in hypercapnic ventilatory response

Change in minute flow of intrapulmonary arterio-venuous anastamoses (QIPAVA)

Change in plasma inflammatory markers

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pre-PFO closureExperimental Treatment1 Intervention

Subjects evaluated at 'baseline' prior to percutaneous closure of PFO, and re-evaluated at 3 months post percutaneous closure of PFO

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatment for Patent Foramen Ovale (PFO) is physical closure, either through surgical or percutaneous methods. This procedure involves sealing the abnormal opening between the atria of the heart, which prevents the abnormal shunting of blood from the right atrium to the left atrium. By closing the PFO, the treatment aims to improve blood flow and reduce the risk of paradoxical embolism, which can lead to strokes or other complications. This is particularly important for PFO patients as it addresses the underlying cause of their symptoms and reduces the risk of future cardiovascular events.