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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 belowSelect...
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
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 moreTrial 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
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.
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Who is running the clinical trial?
University of OregonLead Sponsor
82 Previous Clinical Trials
47,292 Total Patients Enrolled
Andrew Lovering, PhDPrincipal InvestigatorUniversity of Oregon
1 Previous Clinical Trials
82 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 80 years old and am having a procedure to close a hole in my heart.You are allergic to lidocaine, nitroglycerine, or heparin.I have had heart problems like angina or a heart attack before.Both of your hands did not pass a test to check blood flow.If your doctor says that a hole in your heart is not fully closed or healed 6 months after a procedure to close it, you cannot participate in the study.My doctor will decide if I should be in the exercise or non-exercise group.I am on heart or lung medication that I can't stop for 2 days.I am currently pregnant or trying to conceive.
Research Study Groups:
This trial has the following groups:- Group 1: Pre-PFO closure
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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