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

Status unconfirmed · Not applicable

Conditions studied: Patent Foramen Ovale

In brief

The overarching goal of this study is to examine cardiopulmonary and respiratory physiology pre and post PFO/ASD closure in patients who are undergoing surgical closure of their PFO/ASD.

Key facts

Study ID

NCT03904290

Run by

University of Oregon

People needed

10

Starts

2018-04-05

Expected to finish

2024-12-31

Last updated by the study team

2024-02-01

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women aged 18-80
• Undergoing PFO/ASD closure.
• Subject's physician will determine inclusion in either exercise or non-exercise group, based on available medical information.

You may not qualify if…

• Previous history of coronary artery disease (ischemic heart disease such as angina, heart attack, myocardial infarction).
• Failure of Modified Allen's Test in both hands.
• Currently taking medications or herbal supplements for any heart or respiratory disease that they cannot stop taking for 48hrs prior to testing (seasonal allergy medication not included in exclusion medications).
• Lidocaine, nitroglycerine or heparin allergy.
• Women who are pregnant or trying to become pregnant.
• Previous history of any condition that would prevent the subject from performing cycle ergometer exercise (for exercise study only).
• Physician determination.
• PFO/ASD deemed by referring physician as not fully closed/endothelialized at 6 months post-PFO/ASD closure procedure.

Where it is running

• Cardiorespiratory and Pulmonary Physiology Lab — Eugene, Oregon, United States

Full record on ClinicalTrials.gov

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