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Enhanced External Counterpulsation (EECP) for Congenital Heart Disease
N/A
Waitlist Available
Led By Fred Wu, MD
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Individuals with Fontan physiology being seen in the Boston Children's Hospital cardiology clinic for outpatient care.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from completion of eecp treatment until patient discharge (30 to 60 minutes)
Awards & highlights
Study Summary
This trial will test whether a system for compressing the blood vessels in the legs in synchrony with an individual's cardiac rhythm is safe for Fontan patients and whether it has any acute effects on the Fontan circulation or endothelial function.
Eligible Conditions
- Congenital Heart Disease
- Single Ventricle Heart
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from completion of eecp treatment until patient discharge (30 to 60 minutes)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from completion of eecp treatment until patient discharge (30 to 60 minutes)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in cardiac output
Total number and type of adverse events during EECP treatment
Total number and type of adverse events immediately following EECP treatment
Secondary outcome measures
Change in qualitative ventricular systolic function
Change in ventricular strain analysis
Total nitrate/nitrite (NOx) levels
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Enhanced External Counterpulsation (EECP)Experimental Treatment1 Intervention
1 hour of treatment with EECP
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EECP
2017
N/A
~140
Find a Location
Who is running the clinical trial?
Boston Children's HospitalLead Sponsor
756 Previous Clinical Trials
5,579,141 Total Patients Enrolled
Fred Wu, MDPrincipal Investigator - Attending Cardiologist
Boston Children's Hospital
University Of Michigan Medical Sch (Medical School)
Fairview-University Medical Center (Residency)
1 Previous Clinical Trials
12 Total Patients Enrolled
Frequently Asked Questions
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