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

NCT03904290 | Unknown

• 1 other identifier: 12132016.027
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Patent Foramen Ovale

Outcome Measures

Primary Outcomes (7)

• Change in quantified pulmonary gas exchange efficiency

  Quantify pulmonary gas exchange efficiency (alveolar to arterial O2 difference) and arterial oxygenation at rest and during exercise.

  Baseline and 3 months post percutaneous closure

• change in maximal aerobic exercise capacity (Vo2max)

  Quantify aerobic exercise capacity as measured by oxygen consumption

  Baseline and 3 months post percutaneous closure

• change in maximal aerobic exercise capacity

  Distance walked in 6 minutes (6 minute walk test)

  Baseline and 3 months post percutaneous closure

• Change in minute flow of intrapulmonary arterio-venuous anastamoses (QIPAVA)

  Quantify QIPAVA at rest and assess recurrence of stroke or TIA at 3 months.

  Baseline and 3 months post percutaneous closure

• Change in plasma inflammatory markers

  Quantify plasma inflammatory markers (TNFa, IL-1, 6 \& CRP)

  Baseline and 3 months post percutaneous closure

• Change in hypercapnic ventilatory response

  Measure hypercapnic ventilatory response

  Baseline and 3 months post percutaneous closure

• change in core body temperature measured via ingestible thermometer pill

  Quantify core body temperature

  Baseline and 3 months post percutaneous closure

Study Arms (1)

Pre-PFO closure

OTHER

Subjects evaluated at 'baseline' prior to percutaneous closure of PFO, and re-evaluated at 3 months post percutaneous closure of PFO

Other: PFO Closure

Interventions

PFO Closure OTHER

Subject will undergo percutaneous closure of PFO/ASD utilizing FDA-approved PFO/ASD closure device(s).

Pre-PFO closure

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 18-80
• Undergoing PFO/ASD closure.

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.
• 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.

Sponsors & Collaborators

• University of Oregon: lead

Study Sites (1)

Cardiorespiratory and Pulmonary Physiology Lab

Eugene, Oregon, 97403, United States

Location

MeSH Terms

Conditions

Foramen Ovale, Patent

Condition Hierarchy (Ancestors)

Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Andrew Lovering, PhD

  University of Oregon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects brought in for testing prior to PFO closure, then testing repeated 3 months post PFO closure

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 5, 2019
• Study Start: April 5, 2018
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)