EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study

NCT05610787 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: G200252
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 15

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.

Conditions

Heart Failure; Transplant; Failure, Heart; Congenital Heart Disease

Keywords

Pediatric Ventricular Assist Device; Berlin Heart

Outcome Measures

Primary Outcomes (3)

• Rate of Device Malfunction adverse events

  A Device Malfunction per protocol definition, and adjudicated by the Clinical Events Committee.

  Up to 90 days

• Patient Outcome

  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

  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

Study Arms (2)

Active Driver Primary Arm

EXPERIMENTAL

Up to 40 patients whom receive the Active Driver from implant.

Device: EXCOR Active Driving System for Pediatric VAD

IKUS Comparator

NO INTERVENTION

All patients whom receive the (FDA approved) IKUS Driver from implant and are entered into the ACTION Registry.

Interventions

EXCOR Active Driving System for Pediatric VAD DEVICE

The EXCOR Active Driving System - will be used with the EXCOR Pediatric VAD.

Active Driver Primary Arm

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Berlin Heart, Inc: lead

Study Sites (15)

Children's Hospital of Los Angeles

Los Angeles, California, 90027, United States

Location

Lucile Packard Children's Hospital-Stanford

Palo Alto, California, 94304, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Children's National

Washington D.C., District of Columbia, 20010, United States

Location

University of Florida - SHands

Gainesville, Florida, 32610, United States

Location

Ann&Robert H Lurie Children's Hospital

Chicago, Illinois, 60611, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

St Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Levine Children's Hospital

Charlotte, North Carolina, 28203, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

Location

Children's Hospital Wisconsin

Milwaukee, Wisconsin, 53201, United States

Location

MeSH Terms

Conditions

Heart Failure; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open Label, Single Arm, Prospective, Non-Randomized

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: November 9, 2022
• Study Start: November 14, 2022
• Primary Completion: November 10, 2023
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)