Heart FailureNCT05610787
EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study
A study testing EXCOR Active Driving System for Pediatric VAD in people with Heart Failure and Transplant; Failure, Heart, run by Berlin Heart, Inc at 17 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Heart Failure, Transplant; Failure, Heart, Congenital Heart Disease
- What is being tested?
- EXCOR Active Driving System for Pediatric VAD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 17 sitesUnited States
- Study dates
- 14 Nov 2022to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
United States17 sites
CS Mott Children's Hospital
Ann Arbor, Michigan, 48109
Children's Hospital Colorado
Aurora, Colorado, 80045
Dell Children's Medical Center
Austin, Texas, 78723
Boston Children's Hospital
Boston, Massachusetts, 02115
Levine Children's Hospital
Charlotte, North Carolina, 28203
Ann&Robert H Lurie Children's Hospital
Chicago, Illinois, 60611
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
University of Florida - SHands
Gainesville, Florida, 32610
Texas Children's Hospital
Houston, Texas, 77030
Children's Hospital of Los Angeles
Los Angeles, California, 90027
Children's Hospital Wisconsin
Milwaukee, Wisconsin, 53201
Columbia University Medical Center
New York, New York, 10032
Lucile Packard Children's Hospital-Stanford
Palo Alto, California, 94304
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Primary Children's Hospital
Salt Lake City, Utah, 84113
St Louis Children's Hospital
St Louis, Missouri, 63110
Children's National
Washington D.C., District of Columbia, 20010
About this study
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.
Read more
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.
Read the 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.
- Being tested
- EXCOR Active Driving System for Pediatric VAD
- Keywords
- Pediatric Ventricular Assist Device, Berlin Heart
- Medical subject headings
- Heart Failure, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXCOR Active Driving System for Pediatric VADDevice
The EXCOR Active Driving System - will be used with the EXCOR Pediatric VAD.
| Study group | Role | What they receive |
|---|---|---|
| Active Driver Primary Arm | Experimental | Up to 40 patients whom receive the Active Driver from implant. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Device Malfunction adverse events
A Device Malfunction per protocol definition, and adjudicated by the Clinical Events Committee.
Measured: 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.
Measured: 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.
Measured: Up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start14 Nov 2022
- Primary completion10 Nov 2023
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Open Label, Single Arm, Prospective, Non-Randomized
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Berlin Heart, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05610787
- Sponsor's protocol ID
- G200252
- Status last verified
- Oct 2026
- First submitted
- 14 Sep 2022
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study
- ClinicalTrials.gov ID
- NCT05610787
- Acronym / sponsor ID
- G200252
- Keywords
- Pediatric Ventricular Assist Device, Berlin Heart
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Berlin Heart, IncIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 10 Nov 2023 (actual)
- Study completion
- Jan 2027 (estimated)
- First posted
- 9 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open Label, Single Arm, Prospective, Non-Randomized
| Arm | Type | Receives |
|---|---|---|
| Active Driver Primary Arm | Experimental | Device: EXCOR Active Driving System for Pediatric VADUp to 40 patients whom receive the Active Driver from implant. |
| IKUS Comparator | No intervention | –All patients whom receive the (FDA approved) IKUS Driver from implant and are entered into the ACTION Registry. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EXCOR Active Driving System for Pediatric VADThe EXCOR Active Driving System - will be used with the EXCOR Pediatric VAD. | Device | Active Driver Primary Arm |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EXCOR Active Driving System for Pediatric VAD in people with Heart Failure and Transplant; Failure, Heart, run by Berlin Heart, Inc at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Device Malfunction adverse events (time frame: Up to 90 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.