Doppler Analysis of Patent Foramen Ovale

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: 13-006148
    Sponsor Protocol Number: 13-006148

About this study

AIMS:

1. Determine the feasibility of measuring velocity of flow across a patent foramen ovale and using this Doppler spectrum to estimate left atrial pressures.

2. Correlate PFO velocity Doppler profile with the degree of diastolic dysfunction.

3. To Correlated PFO velocity and Doppler derived left atrial pressure with left atrial pressure measured during cardiac catheterization in a subset of (n=20) subjects for validation of this methodology.

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:

  • All patients > 18 years old and clinically stable patients presenting to the Mayo Echocardiography Laboratory for comprehensive transthoracic echocardiogram.
  • In those patients found to have a PFO on screening examination, further interrogation of the PFO with continuous wave Doppler will be performed.
  • This should not involve any further physical maneuvers for the patient and should not delay study time in the clinical study pods.

Exclusion criteria:

  • Difficult echocardiographic 2D images.
  • Patients presenting specifically for limited transthoracic echocardiograms where obtaining subcostal images and performing Doppler interrogation of possible PFO will cause undue delay
  • More than moderate mitral valve disease
  • Frequent ectopic beats

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Jae Oh, M.D.

Contact us for the latest status

Contact information:

Jae Oh M.D.

(507)284-6055

oh.jae@mayo.edu