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EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05610787
Recruitment Status : Recruiting
First Posted : November 9, 2022
Last Update Posted : February 8, 2023
Sponsor:
Information provided by (Responsible Party):
Berlin Heart, Inc

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Heart Failure Transplant; Failure, Heart Congenital Heart Disease Device: EXCOR Active Driving System for Pediatric VAD Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open Label, Single Arm, Prospective, Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study
Actual Study Start Date : November 14, 2022
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : January 2024
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05610787


Contacts
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Contact: Mary Beth Kepler 734-709-2080 mkepler@berlinheartinc.com
Contact: Robert Kroslowitz 281-863-9700 rkroslowitz@berlinheartinc.com

Locations
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United States, California
Children's Hospital of Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Donna Guadiz       donna.guadiz@chla.edu   
Principal Investigator: Jennifer Su, MD         
Lucile Packard Children's Hospital-Stanford Recruiting
Palo Alto, California, United States, 94304
Contact: Jenna Murray       JeMurray@stanfordchildrens.org   
Principal Investigator: John Dykes, MD         
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Megyn Gordon       megyn.gordon@childrenscolorado.org   
Principal Investigator: Scott Auerbach, MD         
United States, District of Columbia
Children's National Recruiting
Washington, District of Columbia, United States, 20010
Contact: Carlos Carhuas       ccarhuas@childrensnational.org   
Principal Investigator: Sairah Khan, MD         
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Courtney Ventresco       Courtney.Ventresco@cardio.chboston.org   
Principal Investigator: Christina Vanderpluym, MD         
United States, Missouri
St Louis Children's Hospital Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Alex Rosenow       alexrosenow@wustl.edu   
Principal Investigator: Deepa Mokshagundam, MD         
United States, North Carolina
Levine Children's Hospital Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Susan Bartos       susan.bartos@atriumhealth.org   
Principal Investigator: Adam Morrison, MD         
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Principal Investigator: Chet Villa, MD         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Julianne Leethe       leethe@chop.edu   
Principal Investigator: Matthew O'Connor, MD         
United States, Utah
Primary Children's Hospital Recruiting
Salt Lake City, Utah, United States, 84113
Contact: Lisa Hansen       lisa.hansen@hsc.utah.edu   
Principal Investigator: Lindsay May, MD         
United States, Wisconsin
Children's Hospital Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53201
Contact: Regina Cole       rcole@childrenswi.org   
Principal Investigator: Alexander Raskin, MD         
Sponsors and Collaborators
Berlin Heart, Inc
More Information
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Responsible Party: Berlin Heart, Inc
ClinicalTrials.gov Identifier: NCT05610787    
Other Study ID Numbers: G200252
First Posted: November 9, 2022    Key Record Dates
Last Update Posted: February 8, 2023
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Berlin Heart, Inc:
Pediatric Ventricular Assist Device
Berlin Heart
Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities