Clinical trial NCT05610787: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Transplant; Failure, Heart
Congenital Heart Disease
Keywords: Pediatric Ventricular Assist Device
Berlin Heart
Lead sponsor: Berlin Heart, Inc
Sponsor class: INDUSTRY
First posted: 2022-11-09
Enrollment: 40
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open Label, Single Arm, Prospective, Non-Randomized
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Rate of Device Malfunction adverse events
timeFrame: Up to 90 days
measure: Patient Outcome
timeFrame: Up to 90 days
measure: Serious Adverse Events
timeFrame: Up to 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital-Stanford
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Washington
country: United States
facility: Children's National
state: District of Columbia
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Saint Louis
country: United States
facility: St Louis Children's Hospital
state: Missouri
city: Charlotte
country: United States
facility: Levine Children's Hospital
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Salt Lake City
country: United States
facility: Primary Children's Hospital
state: Utah
city: Milwaukee
country: United States
facility: Children's Hospital Wisconsin
state: Wisconsin
Study officials:
References: