EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study

Part of paid clinical trials in Los Angeles, California.

Sponsor
Berlin Heart, Inc
Study ID
NCT05610787
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • EXCOR Active Driving System for Pediatric VAD — DEVICE
    The EXCOR Active Driving System - will be used with the EXCOR Pediatric VAD.

Study Details

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.

Key Dates

Start date
Nov 14, 2022
Status verified
Feb 2026
Primary completion
Nov 10, 2023
Completion
Jan 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active Driver Primary Arm
    Up to 40 patients whom receive the Active Driver from implant.
  • No Intervention: IKUS Comparator
    All patients whom receive the (FDA approved) IKUS Driver from implant and are entered into the ACTION Registry.

Primary Outcome Measure

Rate of Device Malfunction adverse events [ Time Frame: Up to 90 days ]

Locations (15)

FacilityCityStateZIPSite coordinators
Children's Hospital of Los AngelesLos AngelesCalifornia90027-
Lucile Packard Children's Hospital-StanfordPalo AltoCalifornia94304-
Children's Hospital ColoradoAuroraColorado80045-
Children's NationalWashington D.C.District of Columbia20010-
University of Florida - SHandsGainesvilleFlorida32610-
Ann&Robert H Lurie Children's HospitalChicagoIllinois60611-
Boston Children's HospitalBostonMassachusetts02115-
St Louis Children's HospitalSt LouisMissouri63110-
Columbia University Medical CenterNew YorkNew York10032-
Levine Children's HospitalCharlotteNorth Carolina28203-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
Texas Children's HospitalHoustonTexas77030-
Primary Children's HospitalSalt Lake CityUtah84113-
Children's Hospital WisconsinMilwaukeeWisconsin53201-

Find similar trials in Los Angeles, CA

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Children's Hospital of Los Angeles· Los Angeles, CALucile Packard Children's Hospital-Stanford· Palo Alto, CAChildren's Hospital Colorado· Aurora, COChildren's National· Washington D.C., DCUniversity of Florida - SHands· Gainesville, FLAnn&Robert H Lurie Children's Hospital· Chicago, IL

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