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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 3 months post percutaneous closure

Awards & highlights

PFO CLOSE Trial Summary

This triallooks at how heart & lung function change after surgery to fix a hole in the heart.

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.Check my eligibility

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.See study design

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.

PFO CLOSE Trial 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.

PFO CLOSE Trial 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

PFO CLOSE 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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of OregonLead Sponsor

80 Previous Clinical Trials

46,749 Total Patients Enrolled

Andrew Lovering, PhDPrincipal InvestigatorUniversity of Oregon

1 Previous Clinical Trials

82 Total Patients Enrolled

Media Library

PFO Closure (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03904290 — N/A

Patent Foramen Ovale Research Study Groups: Pre-PFO closure

Patent Foramen Ovale Clinical Trial 2023: PFO Closure Highlights & Side Effects. Trial Name: NCT03904290 — N/A

PFO Closure (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03904290 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research accommodate individuals aged 55 and over?

"As indicated by the inclusion criteria, enrollees must be at least 18 years old and no more than 80 years of age."

Answered by AI

What type of individuals are eligible for enrollment in this research program?

"For an individual to qualify for the study, they must exhibit a patent foramen ovale and be between 18-80 years old. Approximately 10 participants are sought after."

Answered by AI

Are there any available vacancies for participation in this research project?

"According to clinicaltrials.gov, this medical study is no longer actively enrolling participants. Despite its initial posting on April 5th 2018 and last update in October 12th 2022, there are 23 other trials currently seeking patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Does Patent Foramen Ovale Closure Improve Exercise Capacity & Prevent Blood Flow Through Intrapulmonary Shunt

2018. "Does Patent Foramen Ovale Closure Improve Exercise Capacity & Prevent Blood Flow Through Intrapulmonary Shunt". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03904290.