Cardiohelp ECMO support for children with severe cardiac failure

Multicenter Trial to Evaluate the Safety and Effectiveness of the Cardiohelp System for up to 30 Days of Support in Children With Severe Cardiac Failure

This study will test the Cardiohelp VA-ECMO system for up to 30 days and try heparin versus bivalirudin as anticoagulants in children (0–16 years) with severe heart failure who need VA-ECMO.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 0 Years to 16 Years
• Sex: All
• Sponsor: Stanford University (Academic / other)
• Locations: 5 sites (Palo Alto, California and 4 other locations)
• Trial ID: NCT06080074 on ClinicalTrials.gov

What this trial studies

This multicenter Phase 2 study combines a single-arm device evaluation of the Cardiohelp VA-ECMO system with a randomized comparison of heparin versus bivalirudin as primary anticoagulants in pediatric patients. The device component will collect safety and performance data during up to 30 days of support and compare outcomes to pre-specified pediatric performance benchmarks to inform FDA clearance decisions. The randomized drug component will compare circuit clotting and bleeding outcomes between unfractionated heparin and bivalirudin to inform planning of a pivotal Phase 3 anticoagulation trial. Participating centers include Stanford/Lucile Packard, Columbia/NYP, and Duke, and enrollment is limited to children meeting specific weight, age, and clinical stability criteria for VA-ECMO.

Who should consider this trial

Good fit: Children under 17 years weighing 3–80 kg who require VA-ECMO for primary cardiac failure as their first ECMO run in the current hospitalization and who do not have contraindications to anticoagulation are the intended candidates.

Not a fit: Children with primary respiratory failure, those already on a different ECMO system, with irreversible organ failure, recent stroke, bleeding/coagulopathy contraindicating anticoagulation, comfort-only goals, pregnancy/breastfeeding, or gestationally corrected age under 37 weeks are not eligible and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the study could produce the first FDA-clearance pathway for a standalone pediatric ECMO device and provide evidence on which anticoagulant reduces clotting and bleeding in children on ECMO.

How similar studies have performed: ECMO has longstanding clinical use but no standalone ECMO device has yet received pediatric FDA clearance, and randomized comparisons of heparin versus bivalirudin in pediatric ECMO are limited, so this approach combines established therapy with relatively novel, under-tested components.

Eligibility criteria

Inclusion Criteria:

1. Age 0 to 16 years of age (i.e., \<17 years)
2. Body weight 3 to 80 kilograms
3. VA-ECMO use for primary cardiac failure using the Cardiohelp system.
4. First ECMO run during the current hospitalization

Exclusion Criteria:Children must not meet any of the following exclusion criteria within 48 hours prior to device implant:

1. Gestationally-corrected age \<37 weeks
2. Bleeding or coagulopathy that is a contraindication to anticoagulation
3. Irreversible renal, hepatic or lung failure
4. Stroke or uncertain neurological status within the past 30 days
5. Severely malnourished
6. Use of an ECMO system other than the Cardiohelp
7. VV-ECMO or ECMO for primary respiratory failure
8. Goals of patient to focus on comfort measures only.
9. Failure to separate from cardiopulmonary bypass
10. Allergy or contraindication to receiving UFH or bivalirudin as a primary anticoagulant on ECMO.
11. Patients who are pregnant or breastfeeding.
12. Unable to undergo randomization within 30 hours following ECMO cannulation (randomized cohort only)

Where this trial is running

Palo Alto, California and 4 other locations

• Lucile Packard Children's Hospital — Palo Alto, California, United States (Recruiting)
• Cuimc/Nyph — New York, New York, United States (Recruiting)
• Duke University Hospital — Durham, North Carolina, United States (Recruiting)
• Children's Health Dallas — Dallas, Texas, United States (Recruiting)
• Seattle Children's Hospital — Seattle, Washington, United States (Recruiting)

Study contacts

• Principal investigator: Lynn Sleeper, ScD — Boston Children's Hospital
• Study coordinator: Christopher SD Almond, MD, MPH

Conditions Heart Failure; Cardiogenic Shock; Congenital Heart Disease; Cardiomyopathies; blood thinner; ECMO; heart failure; bivalirudin