EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study

February 6, 2023 updated by: Berlin Heart, Inc

The purpose of this study is to evaluate the device performance and monitor the safety and effectiveness of the Berlin Heart EXCOR Active Driving System while being used with the approved EXCOR Pediatric Ventricular Assist Device.

EXCOR Active Driving System is intended for use with the approved EXCOR Pediatric VAD.

The EXCOR Pediatric VAD is intended to provide mechanical circulatory support as a bridge to cardiac transplantation for pediatric patients. Pediatric candidates with severe isolated left ventricular or biventricular dysfunction who are candidates for cardiac transplant and require circulatory support may be treated using the EXCOR Pediatric.

EXCOR Active is intended for use in a clinical setting. EXCOR Active can be used in any kind of hospital unit (e.g. OR, ICU, intermediate care unit or general care unit). The driving unit may be moved between clinical units using the caddy or baby buggy; however, a patient must always be accompanied by a person trained in the use of the manual pump and emergency procedures during transport in the event of an emergency.

The driving unit can be transported during operation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective study of subjects implanted with the EXCOR Pediatric VAD supported by the EXCOR Active Driving System and patients recently implanted with EXCOR Pediatric supported on the Ikus Driving Unit as reported in the ACTION Registry database.

Children who are transplant eligible in need of mechanical circulatory support and are supported with the EXCOR® Pediatric VAD will be included in this study. All patients must meet the indications and contraindication as indicated in the device labelling. There are no known additional indications or contraindications associated with the EXCOR® Active Driving System beyond those already established in the EXCOR® Pediatric VAD labeling.

The objective of this study is to evaluate device performance and monitor safety and effectiveness of the Berlin Heart EXCOR® Active Driving System while being used with the approved EXCOR® Pediatric Ventricular Assist Device.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Children's Hospital of Los Angeles
        • Contact:
        • Principal Investigator:
          • Jennifer Su, MD
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Lucile Packard Children's Hospital-Stanford
        • Contact:
        • Principal Investigator:
          • John Dykes, MD
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Children's Hospital Colorado
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • St Louis Children's Hospital
        • Contact:
        • Principal Investigator:
          • Deepa Mokshagundam, MD
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Recruiting
        • Levine Children's Hospital
        • Principal Investigator:
          • Adam Morrison, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Children's Hospital of Philadelphia
        • Contact:
        • Principal Investigator:
          • Matthew O'Connor, MD
    • Utah
      • Salt Lake City, Utah, United States, 84113
        • Recruiting
        • Primary Children's Hospital
        • Contact:
        • Principal Investigator:
          • Lindsay May, MD
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53201
        • Recruiting
        • Children's Hospital Wisconsin
        • Contact:
        • Principal Investigator:
          • Alexander Raskin, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient meets all indications as specified in the current version of the Instructions for Use (IFU) of the EXCOR® Pediatric VAD system as shown below:

"EXCOR is intended to provide mechanical circulatory support as a bridge to cardiac transplantation for pediatric patients. Pediatric patients with severe isolated left ventricular or biventricular dysfunction who are candidates for cardiac transplant and require circulatory support may be treated using EXCOR."

• Patient and/or legal representative has signed the study informed consent form.

Exclusion Criteria:

• Patient has any contraindication as specified in the current version of the IFU of the EXCOR® Pediatric VAD system as shown below:

"Patients unable to tolerate systemic anticoagulation therapy should not be implanted with EXCOR components.

Magnetic Resonance Imaging (MRI) is contraindicated in patients after being implanted with EXCOR.

Patients with aortic valve regurgitation that is more than moderate that cannot be re- paired at the time of implantation should not be implanted with EXCOR. If repair of the aortic valve regurgitation requires surgical closure of the aortic valve, EXCOR should not be implanted. EXCOR is not intended to be used as a total artificial heart and should not be used in this configuration."

  • Patient and/or legal representative has not given written consent to participate in the study (non-consent).
  • Females of childbearing age who are not on contraceptives or surgically sterile or pregnant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Active Driver Primary Arm
Up to 40 patients whom receive the Active Driver from implant.
Device: EXCOR Active Driving System for Pediatric VAD
The EXCOR Active Driving System - will be used with the EXCOR Pediatric VAD.
NO_INTERVENTION: IKUS Comparator
All patients whom receive the (FDA approved) IKUS Driver from implant and are entered into the ACTION Registry.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Device Malfunction adverse events
Time Frame: Up to 90 days
A Device Malfunction per protocol definition, and adjudicated by the Clinical Events Committee.
Up to 90 days
Patient Outcome
Time Frame: Up to 90 days

Patient outcomes will be summarized as the proportion of subjects experiencing each outcome and the overall successful outcome. Successful outcome is defined as:

  • survival to recovery/successful weaning -or-
  • survival to explantation not attributed to device malfunction -or-
  • survival on EXCOR® Pediatric at 90 days post-implant

Patients who are removed from support followed by death or for escalation to other therapy (such as another VAD or ECMO) due to major device malfunction attributed to the Active Driving System will be considered failures.
Up to 90 days
Serious Adverse Events
Time Frame: Up to 90 days
Serious Adverse Event rates will be calculated as the rate per 100 patient-months for each individual event as defined in protocol.
Up to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Berlin Heart, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 14, 2022

Primary Completion (ANTICIPATED)

September 1, 2023

Study Completion (ANTICIPATED)

January 1, 2024

Study Registration Dates

First Submitted

September 14, 2022

First Submitted That Met QC Criteria

November 8, 2022

First Posted (ACTUAL)

November 9, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G200252

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

Clinical Trials on EXCOR Active Driving System for Pediatric VAD

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe