Recruiting
Phase 2

Cardiohelp & Heparin

Sponsor:

Stanford University

Code:

NCT06080074

Conditions

Heart Failure

Cardiogenic Shock

Congenital Heart Disease

Cardiomyopathies

Eligibility Criteria

Sex: All

Age: 0 - 16

Healthy Volunteers: Not accepted

Interventions

Cardiohelp device (VA-ECMO)

Heparin

Bivalirudin

Study Details

Brief summary:

There are two primary goals of this multicenter clinical trial that combines an FDA device trial and a phase II drug trial in the same study cohort. These two goals are to:

1. To evaluate the safety and effectiveness of the Cardiohelp Device for VA-ECMO (heart-lung support) for up to 30 days of support in children with severe heart failure with the goal to support its FDA clearance in children.
2. To evaluate heparin versus bivalirudin as the primary blood thinner (anticoagulant) in a randomized trial of children supported with the Cardiohelp ECMO System with the goal to plan a phase III (pivotal) randomized clinical trial

The main questions the Cardiohelp single-arm trial seeks to answer are:

  • What is the safety and effectiveness of the Cardiohelp device for pediatric ECMO?
  • Should the Cardiohelp device be FDA-cleared for children based on the results of the study?
  • What are the optimal performance specifications of the Cardiohelp device in children?

The main questions the blood thinner randomized trial seeks to answer are:

  • Which blood thinner is more promising (i.e., more effective and safer) in children on the Cardiohelp device?
  • How should a pivotal trial of heparin vs. bivalirudin be designed so it is the most informative and efficient to determine the best blood thinner?

Children who are receiving the Cardiohelp device will be approached and consented to participate if interested. For the Cardiohelp device trial, participants will undergo a standardized data collection to estimate survival to 30 days and the prevalence of serious adverse events like stroke, bleeding, and hemolysis. For the blood thinner randomized trial, participants will be randomized 1:1 to blood thinner strategy to determine which blood thinner has the fewest bleeding and clotting complications.

For the Cardiohelp single-arm trial, participant outcomes will be compared to performance goals (PG) derived from the ECMO literature. For the blood thinner randomized trial, the amount of bleeding and clotting will be measured.

The study is funded by an R01 grant from the FDA's Office of Orphan Product Development (OOPD).

Conditions

Heart Failure

Cardiogenic Shock

Congenital Heart Disease

Cardiomyopathies

Study ID

NCT06080074

Start date

Apr 15, 2025

Status verified date

Jan, 2026

Completion date

Sep, 2029

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 16

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age 0 to 16 years of age (i.e., <17 years)
2. Body weight 2.5 to 80 kilograms
3. VA-ECMO use for primary cardiac failure using the Cardiohelp system.
4. First ECMO run during the current hospitalization
5. Written informed consent from the parent or legally appointed representative (LAR)

Exclusion Criteria:Children must not meet any of the following exclusion criteria after ECMO cannulation and immediately prior to consent:

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)

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cardiohelp device managed according to a standardized guideline using heparin anticoagulation

Participants receiving the Cardiohelp device for severe heart failure will be managed according to a standardized treatment guideline (equipment, monitoring, etc.) where heparin is the primary blood thinner to estimate the safety and effectiveness of the device and blood thinner strategy for up to 30 days of support.

experimental: Cardiohelp device managed according to a standardized guideline using bivalirudin anticoagulation

Participants receiving the Cardiohelp device for severe heart failure will be managed according to a standardized treatment guideline (equipment, monitoring, etc.) where bivalirudin is the primary blood thinner to estimate the safety and effectiveness of the device and blood thinner strategy for up to 30 days of support.

Interventions

Cardiohelp device (VA-ECMO)

The Cardiohelp system is a compact cardiopulmonary support system used off-label for ECMO for patients with cardiac and/or respiratory failure. It is currently FDA-cleared for <6 hours of support for cardiopulmonary bypass.

Heparin

Blood thinner that works by inactivating factor Xa that is administered as a continuous intravenous infusion.

Bivalirudin

Blood thinner that works by inhibiting thrombin directly that is administered as a continuous intravenous infusion.

Primary outcome measure

  • Survival to 30 days, recovery, ventricular assist device implant or transplant in the absence of severe symptomatic stroke (primary device effectiveness) [ Time Frame: 30 days of ECMO support or ECMO explant, whichever is earlier. ]
  • Symptomatic stroke (primary device safety) [ Time Frame: 30 days of ECMO support or ECMO explant, whichever is earlier. ]
  • Severe hemolysis (primary device safety) [ Time Frame: 30 days of ECMO support or ECMO explant, whichever is earlier. ]
  • Circuit change due to thrombus (primary device safety) [ Time Frame: 30 days of ECMO support or ECMO explant, whichever is earlier. ]
  • Circuit change due primarily to device malfunction (primary device safety) [ Time Frame: 30 days of ECMO support or ECMO explant, whichever is earlier. ]
  • Renal injury/failure (primary device safety) [ Time Frame: 30 days of ECMO support or ECMO explant, whichever is earlier. ]
  • Circuit-change free survival primarily due to thrombus (primary safety endpoint for anticoagulation RCT) [ Time Frame: 30 days of ECMO support or ECMO explant, whichever is earlier. ]
  • Bleeding [ Time Frame: 30 days of ECMO support or ECMO explant, whichever is earlier. ]

Central Contacts and Locations

Central contacts

Christopher SD Almond, MD, MPH

6507237913calmond@stanford.edu

Selena Gonzales, MPH

650-723-7913selena.gonzales@stanford.edu

Locations

Lucile Packard Children's Hospital

Recruiting

Palo Alto, California, United States, 94304

Contacts

Kate Ryan, MD

650-724-5554kateryan@stanford.edu

Cuimc/Nyph

Recruiting

New York, New York, United States, 10032

Contacts

Eva Cheung, MD

(212) 305-8458ec2335@cumc.columbia.edu

Duke University Hospital

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Caroline Ozment, MD

caroline.ozment@duke.edu

Children's Health Dallas

Recruiting

Dallas, Texas, United States, 95235

Contacts

Sirine Baltagi, MD

Sirine.Baltagi@UTSouthwestern.edu

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Michael McMullan, MD

206-987-2015michael.mcmullan@seattlechildrens.org

More Information

Sponsor

Stanford University

Last update posted

Aug 10, 2026

Last verified

Jan, 2026

Keywords

  • blood thinner
  • ECMO
  • heart failure
  • bivalirudin
  • heparin
  • FDA regulation
  • pediatric medical devices
  • 510k clearance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Stanford University on 2026-08-10.