Study Summary
This trial evaluates the safety & effectiveness of EXCOR Active Driving System when used with EXCOR Pediatric Ventricular Assist Device for patients needing mechanical circulatory support before transplant.
- Congenital Heart Disease
- Heart Failure
- Heart Transplant Failure
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 0 Secondary · Reporting Duration: Up to 90 days
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
IKUS Comparator
1 of 2
Active Driver Primary Arm
1 of 2
Active Control
Experimental Treatment
40 Total Participants · 2 Treatment Groups
Primary Treatment: Active Driver Primary Arm · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age < 65 · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
Is this research endeavor actively recruiting participants?
"This research project, which was first announced on November 14th 2022 is still searching for volunteers. The most recent update to the information hosted on clinicaltrials.gov occurred December 3rd 20202." - Anonymous Online Contributor
What is the cap on participant numbers for this experiment?
"Affirmative, the clinicaltrials.gov webpage states that this medical trial is currently seeking patients to enrol. This study was first published on November 14th 2022 and has been revised as of December 3rd 2022 with a target recruitment size of 40 persons at one site." - Anonymous Online Contributor