Heart Failure With Reduced Ejection FractionPumpKINNCT06348043
Pumps for Kids, Infants and Neonates (PumpKIN): The Jarvik 2015 Pivotal Trial
A study testing Jarvik 2015 LVAD in people with Heart Failure With Reduced Ejection Fraction and Pediatric HD, Stage IV, run by Stanford University.
Trial summary
This is a 22-subject prospective, multicenter, single-arm clinical trial to evaluate the safety and effectiveness of the Jarvik 2015 left ventricular assist device (LVAD) as a bridge to heart transplant in children weighing 8 to 30 kilograms. Read more about this study
- Who is it for?
- Ages 6 months to 16 years
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction, Pediatric HD, Stage IV, LVAD
- What is being tested?
- Jarvik 2015 LVAD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Dec 2029
- 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 6 months to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with severe (Ross or New York Heart Association) class IV HF despite optimal medical therapy (Interagency Registry for Mechanically Assisted Circulatory Support [INTERMACS] profile 1 or 2 for pediatrics) who require mechanical circulatory support as a bridge to transplant and meet all the criteria below:
- Males and females with body weight between 8 kg, and 30 kg
- Body surface area (BSA) between 0.4 m2 and 1.0 m2
- Two-ventricle circulation, including cardiomyopathy, repaired structural heart disease (e.g., anomalous left coronary artery from the pulmonary artery [ALCAPA], aortic stenosis) or acquired heart disease (e.g., , Kawasaki disease) 4. INTERMACS Profile 1 or 2 as evidenced by: a. Inability to wean from extra-corporeal membrane oxygenation (ECMO) or other temporary circulatory support (TCS), OR b.Inability to wean from mechanical ventilator support, OR c. Inotrope-dependent,decompensatedHFANDmeetoneormoreofthe following severity criteria within 48 hours prior to implant (unless otherwise noted), attributed to decompensated HF despite optimal medical therapy: i. Urine output <0.5 cc/kg/hour for 12hr ii. Creatinine level >2 times the upper limit of normal (ULN) for age iii. Alanine aminotransferase (ALT) or total bilirubin level >3 times the ULN for age (either qualifies the patient) iv. Mixed venous oxygen saturation (SvO2) <55% (or arteriovenous oxygen difference >45%) v. Acidosis: Base excess >-5 vi. Inability to tolerate appropriate enteral calories vii. Inability to ambulate or participate in age-appropriate activities of daily living (ADLs) and/or cardiac rehabilitation/physical therapy
- 5. LVAD support is intended for bridge-to transplant. Subject is listed for transplant or eligible (i.e., no medical or surgical contraindications) to be listed for cardiac transplant, United Network for Organ Sharing (UNOS) status 1A, or equivalent 6. Implant performed at a US or European site participating in the Jarvik 2015 IDE Pivotal Trial.
- 7. Written consent of parent(s) or legally authorized representative (LAR) where appropriate.
Show all 11Show fewer
- Exclusion Criteria:1. Severe right ventricular (RV) dysfunction or significant arrhythmia where treatment with a durable RV assist device (RVAD) (i.e., biventricular assist device) is definite or highly likely. 2. Complex cardiac anatomy including but not limited to:
- Single ventricle anatomy
- Presence of a mechanical heart valve
- Unrepairable severe aortic insufficiency 3. Stable inotrope dependence (INTERMACS profile 3) 4. Severe or irreversible renal dysfunction, liver dysfunction or pulmonary dysfunction. 5. Known contraindication to systemic anticoagulation (e.g., coagulopathy) 6. CPR with duration >30 consecutive minutes within 48 hours prior to device implant or CPR with uncertain neurological status 7. ECMO use for >10 consecutive days 8. Known cerebrovascular event within the past 30 days or uncertain neurological status 9. Unmanageable bleeding per judgment of the investigator 10. Ventricular dysfunction that is likely to recover (e.g., acute myocarditis, metabolic myopathy where LV dysfunction is present solely with intermittent acidosis/crises).
- 11. A non-dilated LV as determined by a left ventricular end-diastolic dimension or left ventricular end-diastolic volume z score of <+2.5 12. Systolic dysfunction that is not severe (LV ejection fraction of >35%) (e.g., heart failure with preserved ejection fraction, aka primary diastolic dysfunction). 12. Unresolved malignancy 13. Active, systemic infection unresponsive to antimicrobials therapy 14. Currently participating in an interventional trial whose protocol prevents effective application of the Jarvik 2015 device, potentially has an independent effect on trial endpoints, or otherwise interferes with execution of the PumpKIN protocol
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Ryan Davies, MD, MSC contact
About this study
Official title: Circulatory Support in Pediatric Heart Failure Patients Using the Jarvik 2015 LVAD: A Pivotal
This is a 22-subject prospective, multicenter, single-arm clinical trial to evaluate the safety and effectiveness of the Jarvik 2015 left ventricular assist device (LVAD) as a bridge to heart transplant in children weighing 8 to 30 kilograms. Data generated from the study will be used to support FDA review and potential approval of the device under the Humanitarian Device Exemption (HDE) regulation, the FDA approval pathway for devices intended to treat rare and orphan diseases.
Read the detailed description
This is a NHLBI-funded study is a prospective, multicenter, single-arm clinical trial to evaluate the safety and effectiveness of the Jarvik 2015 left ventricular assist device (LVAD) as a bridge to heart transplant in children where few LVAD options are available and require hospital confinement. Children weighing 8 to 30 kg will be eligible if they have end-stage heart failure refractory to medical therapy due to severe systolic dysfunction. Children with single ventricle heart disease, heart failure with preserved ejection fraction (HFpEF), those requiring BIVAD support, and those with irreversible end-organ dysfunction will be excluded. The primary probable benefit endpoint of the study is survival to heart transplant, recovery or 180 days of support in the absence of severe stroke. The primary safety endpoint of the study is freedom from any new symptomatic stroke. A total of 22 subjects will be enrolled in the trial at 14 sites in the US and Europe. Subjects will be enrolled over roughly 3 years (38 months) and followed for 1 year post explant. Data generated from the study will be used to support FDA review and potential approval of the device under the Humanitarian Device Exemption (HDE) regulation, the FDA approval pathway for devices intended to treat rare and orphan diseases. Children
- Being tested
- Jarvik 2015 LVAD
- Keywords
- LVAD, Pediatric heart failure, advanced cardiac therapies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jarvik 2015 LVADDevice
Medical device used to treat children awaiting heart transplant who fail optimal medical therapy.
| Study group | Role | What they receive |
|---|---|---|
| LVAD support with the Jarvik 2015 | Experimental | Children implanted with the Jarvik 2015 LVAD as a bridge to heart transplant Receives: Device: Jarvik 2015 LVAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival to heart transplant, recovery or 180 days of support in the absence of severe stroke.
Patient survival to heart transplant, recovery or 180 days of support in the absence of severe stroke as defined by the Pediatric Stroke Outcomes Measure (PSOM, (range 0 to 10 with 0 no deficit to 10 maximum deficit) performed at 12 months post-explant. Severe stroke is defined an abnormal PSOM score due to stroke that meets the following criteria: PSOM score of 3-4 in Part A (sensory and motor assessment) OR Score of 3-4 in Parts B and C combined (language comprehension and language production) OR Score of 2 in Part D (cognitive or behavioral deficit).
Measured: 180 days
Freedom from symptomatic stroke
Freedom from symptomatic stroke based on the 12-month Pediatric Stroke Outcome Measure (PSOM, symptomatic stroke defined as a PSOM >0 due to stroke, PSOM score range 0-10 with higher scores corresponding to more severe stroke injury). Participants meet criteria for no stroke if they do not meet ACTION criteria for stroke at 12 months or stroke is present with a PSOM score of 0).
Measured: 12 months post-explant
Secondary outcomes (4)
Incidence rate of all protocol-defined SAE's through 180 days of support definitely or probably related to the device
Incidence rate of all protocol-defined SAE's through 180 days of support definitely or probably related to the device using the ACTION definitions and rules for censoring and attribution, the industry standard in pediatric VAD therapy
Measured: 180 days
Distribution of Pediatric Stroke Outcomes Measures
Distribution of Pediatric Stroke Outcomes Measures (PSOM scores) in children with a new stroke diagnosis during the trial as assessed at 12 months post-explant.
Measured: 12-months post explant for stroke occurring during the first 180 days of support
The KOSCHI score
The Kings Outcomes Scale for Children Head Injury (KOSCHI) score (range 1-5, with 1-poor to 5-good functional state) for those diagnosed with a new stroke during the first 180 days as measured at 12 months post-explant.
Measured: 12 months post-explant in children with strokes occurring during the first 180 days of support
Overall survival on Jarvik 2015 support to 180 days
Overall patient survival on Jarvik 2015 support without converting to a non-Jarvik device for left heart support (Kaplan-Meier estimate)
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study startAug 2024 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas, Carelon Research, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Christopher Almond, Stanford University
- Investigators
- William T Mahle, MD, Study chair, Children's Healthcare of Atlanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348043
- Sponsor's protocol ID
- SU_PumpKIN
- Other IDs
- 1UG3HL163311-01A1
- Acronym
- PumpKIN
- Status last verified
- Mar 2024
- First submitted
- 29 Mar 2024
- Last updated
- 4 Apr 2024
- 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 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulatory Support in Pediatric Heart Failure Patients Using the Jarvik 2015 LVAD: A Pivotal
- ClinicalTrials.gov ID
- NCT06348043
- Acronym / sponsor ID
- PumpKIN / SU_PumpKIN
- Keywords
- LVAD, Pediatric heart failure, advanced cardiac therapies
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- University of Texas, Carelon Research, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 2024 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 4 Apr 2024 (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.
This is a 22-subject prospective, multicenter, single-arm clinical trial to evaluate the safety and effectiveness of the Jarvik 2015 left ventricular assist device (LVAD) as a bridge to heart transplant in children weighing 8 to 30 kilograms. Data generated from the study will be used to support FDA review and potential approval of the device under the Humanitarian Device Exemption (HDE) regulation, the FDA approval pathway for devices intended to treat rare and orphan diseases.
Detailed description
This is a NHLBI-funded study is a prospective, multicenter, single-arm clinical trial to evaluate the safety and effectiveness of the Jarvik 2015 left ventricular assist device (LVAD) as a bridge to heart transplant in children where few LVAD options are available and require hospital confinement. Children weighing 8 to 30 kg will be eligible if they have end-stage heart failure refractory to medical therapy due to severe systolic dysfunction. Children with single ventricle heart disease, heart failure with preserved ejection fraction (HFpEF), those requiring BIVAD support, and those with irreversible end-organ dysfunction will be excluded. The primary probable benefit endpoint of the study is survival to heart transplant, recovery or 180 days of support in the absence of severe stroke. The primary safety endpoint of the study is freedom from any new symptomatic stroke. A total of 22 subjects will be enrolled in the trial at 14 sites in the US and Europe. Subjects will be enrolled over roughly 3 years (38 months) and followed for 1 year post explant. Data generated from the study will be used to support FDA review and potential approval of the device under the Humanitarian Device Exemption (HDE) regulation, the FDA approval pathway for devices intended to treat rare and orphan diseases. Children
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LVAD support with the Jarvik 2015 | Experimental | Device: Jarvik 2015 LVADChildren implanted with the Jarvik 2015 LVAD as a bridge to heart transplant |
Who may qualify
- Ages
- 6 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Children with severe (Ross or New York Heart Association) class IV HF despite optimal medical therapy (Interagency Registry for Mechanically Assisted Circulatory Support [INTERMACS] profile 1 or 2 for pediatrics) who require mechanical circulatory support as a bridge to transplant and meet all the criteria below:
- Males and females with body weight between 8 kg, and 30 kg
- Body surface area (BSA) between 0.4 m2 and 1.0 m2
- Two-ventricle circulation, including cardiomyopathy, repaired structural heart disease (e.g., anomalous left coronary artery from the pulmonary artery [ALCAPA], aortic stenosis) or acquired heart disease (e.g., , Kawasaki disease) 4. INTERMACS Profile 1 or 2 as evidenced by: a. Inability to wean from extra-corporeal membrane oxygenation (ECMO) or other temporary circulatory support (TCS), OR b.Inability to wean from mechanical ventilator support, OR c. Inotrope-dependent,decompensatedHFANDmeetoneormoreofthe following severity criteria within 48 hours prior to implant (unless otherwise noted), attributed to decompensated HF despite optimal medical therapy: i. Urine output <0.5 cc/kg/hour for 12hr ii. Creatinine level >2 times the upper limit of normal (ULN) for age iii. Alanine aminotransferase (ALT) or total bilirubin level >3 times the ULN for age (either qualifies the patient) iv. Mixed venous oxygen saturation (SvO2) <55% (or arteriovenous oxygen difference >45%) v. Acidosis: Base excess >-5 vi. Inability to tolerate appropriate enteral calories vii. Inability to ambulate or participate in age-appropriate activities of daily living (ADLs) and/or cardiac rehabilitation/physical therapy
- 5. LVAD support is intended for bridge-to transplant. Subject is listed for transplant or eligible (i.e., no medical or surgical contraindications) to be listed for cardiac transplant, United Network for Organ Sharing (UNOS) status 1A, or equivalent 6. Implant performed at a US or European site participating in the Jarvik 2015 IDE Pivotal Trial.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Jarvik 2015 LVADMedical device used to treat children awaiting heart transplant who fail optimal medical therapy. | Device | LVAD support with the Jarvik 2015 |
Primary outcome
Survival to heart transplant, recovery or 180 days of support in the absence of severe stroke.
Time frame: 180 days
Patient survival to heart transplant, recovery or 180 days of support in the absence of severe stroke as defined by the Pediatric Stroke Outcomes Measure (PSOM, (range 0 to 10 with 0 no deficit to 10 maximum deficit) performed at 12 months post-explant. Severe stroke is defined an abnormal PSOM score due to stroke that meets the following criteria: PSOM score of 3-4 in Part A (sensory and motor assessment) OR Score of 3-4 in Parts B and C combined (language comprehension and language production) OR Score of 2 in Part D (cognitive or behavioral deficit).
Freedom from symptomatic stroke
Time frame: 12 months post-explant
Freedom from symptomatic stroke based on the 12-month Pediatric Stroke Outcome Measure (PSOM, symptomatic stroke defined as a PSOM >0 due to stroke, PSOM score range 0-10 with higher scores corresponding to more severe stroke injury). Participants meet criteria for no stroke if they do not meet ACTION criteria for stroke at 12 months or stroke is present with a PSOM score of 0).
4 secondary outcomes
Incidence rate of all protocol-defined SAE's through 180 days of support definitely or probably related to the device
Time frame: 180 days
Distribution of Pediatric Stroke Outcomes Measures
Time frame: 12-months post explant for stroke occurring during the first 180 days of support
The KOSCHI score
Time frame: 12 months post-explant in children with strokes occurring during the first 180 days of support
Overall survival on Jarvik 2015 support to 180 days
Time frame: 180 days
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 4 Apr 2024.
- 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.
Ryan Davies, MD, MSC contact
William T Mahle, MD study chair
Children's Healthcare of Atlanta
Questions about this trial
What is this clinical trial studying?
A study testing Jarvik 2015 LVAD in people with Heart Failure With Reduced Ejection Fraction and Pediatric HD, Stage IV, run by Stanford University.
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 11 inclusion and 0 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: opening soon, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Christopher SD Almond, MD, MPH (6507237913, calmond@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival to heart transplant, recovery or 180 days of support in the absence of severe stroke. (time frame: 180 days). The study lists 2 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 4 Apr 2024.