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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 2
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).

Eligibility
Participation Requirements
Sex: All
Maximum Age: 16
Healthy Volunteers: f
View:

• Age 0 to 16 years of age (i.e., \<17 years)

• Body weight 3 to 80 kilograms

• VA-ECMO use for primary cardiac failure using the Cardiohelp system.

• First ECMO run during the current hospitalization

Locations
United States
California
Lucile Packard Children's Hospital
RECRUITING
Palo Alto
North Carolina
Duke University Hospital
RECRUITING
Durham
New York
Cuimc/Nyph
RECRUITING
New York
Texas
Children's Health Dallas
RECRUITING
Dallas
Washington
Seattle Children's Hospital
RECRUITING
Seattle
Contact Information
Primary
Christopher SD Almond, MD, MPH
calmond@stanford.edu
6507237913
Backup
Selena Gonzales, MPH
selena.gonzales@stanford.edu
650-723-7913
Time Frame
Start Date: 2025-04-15
Estimated Completion Date: 2029-09
Participants
Target number of participants: 50
Treatments
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.
Sponsors
Leads: Stanford University
Collaborators: Boston Children's Hospital, Duke University, FDA Office of Orphan Products Development

This content was sourced from clinicaltrials.gov