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Mechanical Circulatory Support Device
EXCOR Active Driving System for Pediatric Heart Failure
N/A
Recruiting
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
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.
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.Check my eligibility
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 90 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patient Outcome
Rate of Device Malfunction adverse events
Serious Adverse Events
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.
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Who is running the clinical trial?
Berlin Heart, IncLead Sponsor
4 Previous Clinical Trials
159 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are a pediatric patient with severe heart problems who needs a mechanical heart support device as a bridge to a heart transplant.
Research Study Groups:
This trial has the following groups:- Group 1: Active Driver Primary Arm
- Group 2: IKUS Comparator
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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