Doppler Analysis of Patent Foramen Ovale
Overview
Tab Title Description
Study type
ObservationalDescribes 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.
Study IDs
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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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 the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Jae Oh, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available