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NCT04956952 · ClinicalTrials.gov registry record · NA
Enhanced External Counterpulsation in Patients With Fontan Circulation
A NA study of Congenital Heart Disease and Single-ventricle, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 23
- Enrollment target
- 1
- Study location
NCT04956952: Completed NA study of Congenital Heart Disease and Single-ventricle, sponsored by Boston Children's Hospital.
NCT04956952 is a NA study of Congenital Heart Disease and Single-ventricle that has completed, run by Boston Children's Hospital. The registered enrollment target is 23 participants, below the 474-participant average among 63 other Congenital Heart Disease trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04956952, a NA study of Congenital Heart Disease and Single-ventricle, has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 23 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Measurement of cardiac output (pulmonary blood flow) in L/min using inert gas rebreathing method (Innocor CO device)
Conditions Studied
Interventions
- DEVICE EECP
Study Locations (1)
Massachusetts
- Boston Children's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2022-03-31 |
| Est. Completion | 2023-05-17 |
| Phase | NA |
What the finished NCT04956952 record still lists
NCT04956952 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 474-participant average among 63 other Congenital Heart Disease trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Congenital Heart Disease appearing as the primary indexed condition, and to 1 intervention - of which EECP is the first listed.
NCT04956952 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04956952 about?
NCT04956952 is a clinical study titled "Enhanced External Counterpulsation in Patients With Fontan Circulation". 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 myocard...
What is the current status of trial NCT04956952?
This trial is currently completed. It is a NA study. The enrollment target is 23 participants. The study started on 2022-03-31. Estimated completion is 2023-05-17.
What conditions does trial NCT04956952 study?
This clinical trial studies the following conditions: Congenital Heart Disease, Single-ventricle.
What interventions are being tested in trial NCT04956952?
The interventions under investigation include: EECP (DEVICE).
Who is sponsoring clinical trial NCT04956952?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04956952 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Congenital Heart Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04956952's enrollment target sits among peer trials
23 60th of 63 higher than 4 of 63 other Congenital Heart Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Congenital Heart Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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