Enhanced External Counterpulsation in Patients With Fontan Circulation (NCT04956952) | Clinical Trial Compass
CompletedNot Applicable
Enhanced External Counterpulsation in Patients With Fontan Circulation
United States23 participantsStarted 2022-03-31
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Individuals with Fontan physiology being seen in the Boston Children's Hospital cardiology clinic for outpatient care.
Exclusion Criteria:
* Current pregnancy
* Decompensated heart failure/pulmonary edema
* Severe aortic insufficiency
* Active tachyarrhythmias
* Frequent atrial or ventricular ectopy
* Symptomatic peripheral vascular disease
* Thrombophlebitis or history of deep vein thrombosis or stasis ulcer
* Aortic aneurysm
* Uncontrolled hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure\>110 mmHg)
* Systolic blood pressure \<90 mmHg
* Active femoral site bleeding or hematoma
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
2
Total number and type of adverse events during EECP treatment
Timeframe: During EECP treatment (duration 60 minutes)
3
Total number and type of adverse events immediately following EECP treatment
Timeframe: From completion of EECP treatment until patient discharge (30 to 60 minutes)