Non-Invasive Cardiac Output Monitoring (NICOM) in Adult Congenital Heart Disease Patients with Fontan Palliation

W
W Aaron Kay, MD

Primary Investigator

Not Recruiting
18 years - 100 years
All
Phase N/A
1 Location

Brief description of study

The purpose of this study is to compare information collected for the purpose of this study to information collected during your routine, scheduled heart procedure.

Detailed description of study

In adults with normal anatomy, hearts experiencing failure (most often due to coronary artery disease, uncontrolled hypertension, or non-ischemic cardiomyopathy) the use of a FDA approved non-invasive cardiac output monitoring (NICOM, Starling SV model, Cheetah Medical) to assist in monitoring and management on fluid status and response to therapy is becoming a promising method. Previously, placement of a Swan-Ganz catheter in the SVC to the pulmonary vasculature was considered standard in monitoring heart failure patients, however this method is invasive and prohibitive in Fontan patients due to an excessive risk of complications, such as thrombosis or Fontan occlusion. Right Heart Catheterization (RHC) is considered the gold standard for measurement of Cardiac Output (CO) and Cardiac Index (CI) in both normal anatomy and Fontan physiology patients, however this method is invasive, requires contrast exposure, and requires a team of physicians and technicians experienced in cardiac catheterization, especially in the adult congenital population. This method is also not always feasible in unstable patients or patients with acutely decompensated heart failure.

By using a NICOM device at the same time as RHC, we aim to correlate NICOM measurements with the ?gold standard? in this unique population. We predict that this will provide evidence and support the routine use of NICOM in managing adults with Fontan palliation admitted for heart failure. Long term, we believe this will improve care and reduce costs, length of stay, morbidity (including AKI, congestive hepatopathy, or worsening heart failure) and mortality in our patients. These factors will need to be addressed in subsequent studies once the use of NICOM is incorporated into management of adult Fontan heart failure.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: congenital heart disease,adult congenital heart disease
  • Age: 18 years - 100 years
  • Gender: All

Inclusion Criteria
Adults over age 18 who are status post-Fontan complete palliation and referred for routine outpatient cardiac catheterization as part of their clinical care
Exclusion Criteria
Incomplete Fontan (hemi-Fontan) correction
Developmental delay and/or otherwise unable to provide consent
Prisoner or ward of the state
Pregnancy


Additional Information:

Updated on 01 Aug 2024. Study ID: 1805574385

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