The purpose of the proposed study is to determine the safety of enhanced external counterpulsation (EECP), a system for compressing the blood vessels in the legs in synchrony with an individual's cardiac rhythm, in clinically well, adult Fontan patients, to document the acute hemodynamic and myocardial effects of EECP on the Fontan circulation, and to demonstrate acute changes in endothelial function after one hour of the procedure.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Change in cardiac output
Timeframe: Immediately prior to starting EECP treatment, during each 20-minute phase of EECP treatment, and 30 minutes after EECP treatment
Total number and type of adverse events during EECP treatment
Timeframe: During EECP treatment (duration 60 minutes)
Total number and type of adverse events immediately following EECP treatment
Timeframe: From completion of EECP treatment until patient discharge (30 to 60 minutes)