Active Driver Primary Arm for Congenital Heart Disease

Phase-Based Progress Estimates
Children's Hospital Wisconsin, Milwaukee, WICongenital Heart Disease+2 MoreEXCOR Active Driving System for Pediatric VAD - Device
< 65
All Sexes
What conditions do you have?

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.

Eligible Conditions
  • Congenital Heart Disease
  • Heart Failure
  • Heart Transplant Failure

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

3 Primary · 0 Secondary · Reporting Duration: Up to 90 days

Up to 90 days
Patient Outcome
Rate of Device Malfunction adverse events
Serious Adverse Events

Trial Safety

Safety Progress

1 of 3

Similar Trials

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

Active Driver Primary Arm
Experimental Group · 1 Intervention: EXCOR Active Driving System for Pediatric VAD · Intervention Types: Device
IKUS ComparatorNoIntervention Group · 1 Intervention: IKUS Comparator · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 90 days

Who is running the clinical trial?

Berlin Heart, IncLead Sponsor
4 Previous Clinical Trials
159 Total Patients Enrolled

Eligibility Criteria

Age < 65 · All Participants · 2 Total Inclusion Criteria

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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 occurred December 3rd 20202." - Anonymous Online Contributor

Unverified Answer

What is the cap on participant numbers for this experiment?

"Affirmative, the 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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.