PFO Closure for Heart Hole (Patent Foramen Ovale)
(PFO CLOSE Trial)
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Oregon
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
What is the purpose of this trial?
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.
Research Team
AL
Andrew Lovering, PhD
Principal Investigator
University of Oregon
Eligibility Criteria
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
My doctor will decide if I should be in the exercise or non-exercise group.
Exclusion Criteria
You are allergic to lidocaine, nitroglycerine, or heparin.
I have had heart problems like angina or a heart attack before.
Previous history of any condition that would prevent the subject from performing cycle ergometer exercise (for exercise study only).
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Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Pre-PFO closure evaluation
Subjects evaluated at 'baseline' prior to percutaneous closure of PFO
Baseline
1 visit (in-person)
Post-PFO closure evaluation
Subjects re-evaluated at 3 months post percutaneous closure of PFO
3 months
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- PFO Closure
Trial Overview 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.
Participant Groups
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
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Who Is Running the Clinical Trial?
University of Oregon
Lead Sponsor
Trials
91
Recruited
46,700+
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