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Mechanical Circulatory Support Device

EXCOR Active Driving System for Pediatric Heart Failure

Milwaukee, WI
N/A
Waitlist Available
Research Sponsored by Berlin Heart, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 90 days
Awards & highlights
No Placebo-Only Group

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.

See full description
Who is the study for?
This trial is for pediatric patients with severe heart dysfunction who need a bridge to heart transplantation. Candidates must meet the device's usage guidelines, agree to systemic anticoagulation therapy, and not require MRI scans. Pregnant females or those able to conceive without contraception are excluded.
What is being tested?
The study tests the Berlin Heart EXCOR Active Driving System used with the approved EXCOR Pediatric VAD in clinical settings. It aims to support children awaiting heart transplants by assisting their cardiac function mechanically.See study design
What are the potential side effects?
Potential side effects may include complications related to mechanical circulatory support devices such as bleeding due to anticoagulation therapy, infection risks at surgical sites or device interfaces, and possible device malfunction requiring emergency procedures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Patient Outcome
Rate of Device Malfunction adverse events
Serious Adverse Events

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Active Driver Primary ArmExperimental Treatment1 Intervention
Up to 40 patients whom receive the Active Driver from implant.
Group II: IKUS ComparatorActive Control1 Intervention
All patients whom receive the (FDA approved) IKUS Driver from implant and are entered into the ACTION Registry.

Find a Location

Closest Location:Children's Hospital Wisconsin· Milwaukee, WI

Who is running the clinical trial?

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

Media Library

EXCOR Pediatric VAD (Mechanical Circulatory Support Device) Clinical Trial Eligibility Overview. Trial Name: NCT05610787 — N/A
Congenital Heart Disease Research Study Groups: Active Driver Primary Arm, IKUS Comparator
Congenital Heart Disease Clinical Trial 2023: EXCOR Pediatric VAD Highlights & Side Effects. Trial Name: NCT05610787 — N/A
EXCOR Pediatric VAD (Mechanical Circulatory Support Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05610787 — N/A
~12 spots leftby Mar 2026
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