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Enhanced External Counterpulsation in Patients With Fontan Circulation

NCT04956952 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2023-06-13

No results posted yet for this study

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.

Conditions

  • Single-ventricle
  • Congenital Heart Disease

Interventions

DEVICE

EECP

1 hour of treatment with EECP

Sponsors & Collaborators

Principal Investigators

  • Fred Wu, MD · Attending Cardiologist

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-31
Primary Completion
2023-05-17
Completion
2023-05-17
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04956952 on ClinicalTrials.gov