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Search / Trial NCT03904290

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

Launched by UNIVERSITY OF OREGON · Apr 2, 2019

Trial Information

Current as of June 26, 2025

Enrolling by invitation

Keywords

ClinConnect Summary

A patent foramen ovale (PFO) is present in \~30% of the general population. The PFO has historically been considered to be trivial. However, recent work by the investigator's group and others has identified that, compared to individuals without a PFO, those with a PFO have a higher core body temperature, significantly worse pulmonary gas exchange efficiency, blunted ventilatory responses to chronic hypoxia and acute carbon dioxide and increased susceptibility to altitude illnesses such as acute mountain sickness, and high altitude pulmonary edema. Specific to this application, subjects with...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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.
  • Exclusion Criteria:
  • 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.

About University Of Oregon

The University of Oregon is a leading research institution dedicated to advancing scientific knowledge and improving public health through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, the university leverages its expertise in various fields, including psychology, neuroscience, and public health, to conduct rigorous studies that address critical health challenges. Committed to ethical research practices and participant welfare, the University of Oregon fosters an environment of academic excellence, driving forward the discovery of new treatments and interventions that enhance the quality of life for diverse populations.

Locations

Eugene, Oregon, United States

Patients applied

0 patients applied

Trial Officials

Andrew Lovering, PhD

Principal Investigator

University of Oregon

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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