PFO Closure for Heart Hole (Patent Foramen Ovale)
(PFO CLOSE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to study heart and lung health before and after a procedure to close a heart hole, known as Patent Foramen Ovale (PFO). The researchers seek to understand how this closure affects breathing and heart function. Ideal participants are those scheduled for the PFO closure procedure and without a history of heart disease, such as heart attacks or angina. Researchers will assess participants before the procedure and again three months after to observe any changes. As an unphased trial, this study offers participants the opportunity to contribute to valuable research that could enhance future treatments for heart and lung health.
Do I need to stop taking my current medications for the trial?
Yes, you will need to stop taking any heart or respiratory medications or herbal supplements 48 hours before testing, unless it's for seasonal allergies.
What prior data suggests that PFO closure is safe?
Research has shown that closing a PFO, a small hole in the heart, is generally safe. Evidence suggests that this procedure effectively prevents strokes over time. Studies have found that most patients experience good results with a low risk of serious issues afterward. For instance, older patients tend to have low rates of new heart problems after the procedure. While some risks, such as irregular heartbeats, exist, they are uncommon. Overall, most patients tolerate PFO closure well.12345
Why are researchers excited about this trial?
PFO Closure is unique because it offers a direct solution to a common heart condition known as a patent foramen ovale, or PFO, which is essentially a hole in the heart. While most current treatments focus on managing symptoms or reducing risk factors, PFO Closure actually seals the hole with a minimally invasive procedure. This contrasts with standard medical management like blood thinners, which don't address the physical defect. Researchers are excited because this approach can potentially prevent strokes and other complications associated with PFO more effectively, offering a more targeted and permanent solution.
What evidence suggests that PFO closure might be an effective treatment for heart hole?
Research has shown that closing a patent foramen ovale (PFO), a small hole in the heart, can lower the risk of recurrent strokes. In this trial, participants will undergo PFO closure. Studies indicate that combining PFO closure with antiplatelet therapy (medicine that prevents blood cells from sticking together) significantly reduces the chance of another stroke. One study found that more than 90% of patients had successful PFO closure using various devices. This procedure is commonly performed and has proven safe over the long term. Overall, closing a PFO can effectively prevent future strokes in individuals with a history of strokes.56789
Who Is on the Research Team?
Andrew Lovering, PhD
Principal Investigator
University of Oregon
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-PFO closure evaluation
Subjects evaluated at 'baseline' prior to percutaneous closure of PFO
Post-PFO closure evaluation
Subjects re-evaluated at 3 months post percutaneous closure of PFO
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- PFO Closure
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Oregon
Lead Sponsor