A Study of Pulmonary Artery Angioplasty on Exercise Capacity and Symptoms in Children and Adults with Unilateral Proximal Pulmonary Artery Stenosis

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 12-008649
    Sponsor Protocol Number: 12-008649

About this study

The purpose of this study is to find out the effect of opening up a narrowed blood vessel supplying the lungs (pulmonary artery) on the exercise capacity of these subjects.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  1. Children 13 years of age and older and adults with known or suspected unilateral proximal pulmonary artery stenosis referred to participating institutions for elective cardiac catheterization and who undergo unilateral proximal PA angioplasty (with or without stenting) will be enrolled in the study.

Exclusion Criteria:

  1. Children under 13 years of age
  2. Patients who are incapable of performing a maximal exercise test with expiratory gas analysis
  3. Patients who are unable/unwilling to return for follow up exercise/lung perfusion scan testing
  4. Patients who undergo multiple vessel dilations
  5. Patients with distal /multiple branch PA stenosis
  6. Patients who have other interventions during the catheterization such as a percutaneous pulmonary valve replacement that could significantly confound the results of exercise testing and symptoms post procedure. 
  7. Patients with non-cardiac medical conditions that could affect ventilation such as neuromuscular disorders, myopathies, airway obstruction, chronic metabolic acidosis
  8. Patients who have not had cardiopulmonary exercise testing and lung perfusion scan/cardiac MRI to assess differential pulmonary blood flow before the catheterization

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Nathaniel Taggart, M.D.

Closed for enrollment

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CLS-20325799

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