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EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EXCOR Active Driving System for Pediatric VAD
Sponsored by
Berlin Heart, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Pediatric Ventricular Assist Device, Berlin Heart

Eligibility Criteria

undefined - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's Hospital of Los AngelesRecruiting
  • Lucile Packard Children's Hospital-StanfordRecruiting
  • Children's Hospital ColoradoRecruiting
  • Children's NationalRecruiting
  • Boston Children's HospitalRecruiting
  • St Louis Children's HospitalRecruiting
  • Levine Children's HospitalRecruiting
  • Cincinnati Children's Hospital Medical CenterRecruiting
  • Children's Hospital of PhiladelphiaRecruiting
  • Primary Children's HospitalRecruiting
  • Children's Hospital WisconsinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Active Driver Primary Arm

IKUS Comparator

Arm Description

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

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

Outcomes

Primary Outcome Measures

Rate of Device Malfunction adverse events
A Device Malfunction per protocol definition, and adjudicated by the Clinical Events Committee.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 14, 2022
Last Updated
February 6, 2023
Sponsor
Berlin Heart, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT05610787
Brief Title
EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study
Official Title
EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 14, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Berlin Heart, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Transplant; Failure, Heart, Congenital Heart Disease
Keywords
Pediatric Ventricular Assist Device, Berlin Heart

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Open Label, Single Arm, Prospective, Non-Randomized
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Driver Primary Arm
Arm Type
Experimental
Arm Description
Up to 40 patients whom receive the Active Driver from implant.
Arm Title
IKUS Comparator
Arm Type
No Intervention
Arm Description
All patients whom receive the (FDA approved) IKUS Driver from implant and are entered into the ACTION Registry.
Intervention Type
Device
Intervention Name(s)
EXCOR Active Driving System for Pediatric VAD
Intervention Description
The EXCOR Active Driving System - will be used with the EXCOR Pediatric VAD.
Primary Outcome Measure Information:
Title
Rate of Device Malfunction adverse events
Description
A Device Malfunction per protocol definition, and adjudicated by the Clinical Events Committee.
Time Frame
Up to 90 days
Title
Patient Outcome
Description
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.
Time Frame
Up to 90 days
Title
Serious Adverse Events
Description
Serious Adverse Event rates will be calculated as the rate per 100 patient-months for each individual event as defined in protocol.
Time Frame
Up to 90 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Beth Kepler
Phone
734-709-2080
Email
mkepler@berlinheartinc.com
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Kroslowitz
Phone
281-863-9700
Email
rkroslowitz@berlinheartinc.com
Facility Information:
Facility Name
Children's Hospital of Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donna Guadiz
Email
donna.guadiz@chla.edu
First Name & Middle Initial & Last Name & Degree
Jennifer Su, MD
Facility Name
Lucile Packard Children's Hospital-Stanford
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jenna Murray
Email
JeMurray@stanfordchildrens.org
First Name & Middle Initial & Last Name & Degree
John Dykes, MD
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megyn Gordon
Email
megyn.gordon@childrenscolorado.org
First Name & Middle Initial & Last Name & Degree
Scott Auerbach, MD
Facility Name
Children's National
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Carhuas
Email
ccarhuas@childrensnational.org
First Name & Middle Initial & Last Name & Degree
Sairah Khan, MD
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Courtney Ventresco
Email
Courtney.Ventresco@cardio.chboston.org
First Name & Middle Initial & Last Name & Degree
Christina Vanderpluym, MD
Facility Name
St Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alex Rosenow
Email
alexrosenow@wustl.edu
First Name & Middle Initial & Last Name & Degree
Deepa Mokshagundam, MD
Facility Name
Levine Children's Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Bartos
Email
susan.bartos@atriumhealth.org
First Name & Middle Initial & Last Name & Degree
Adam Morrison, MD
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chet Villa, MD
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julianne Leethe
Email
leethe@chop.edu
First Name & Middle Initial & Last Name & Degree
Matthew O'Connor, MD
Facility Name
Primary Children's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Hansen
Email
lisa.hansen@hsc.utah.edu
First Name & Middle Initial & Last Name & Degree
Lindsay May, MD
Facility Name
Children's Hospital Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regina Cole
Email
rcole@childrenswi.org
First Name & Middle Initial & Last Name & Degree
Alexander Raskin, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study

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