Heart FailurePhase 2TROLLEYNCT06080074
Multicenter Trial of ECMO in Children With Severe Cardiac Failure Using the Cardiohelp System
A Phase 2 study testing Cardiohelp device (VA-ECMO), Heparin and Bivalirudin in people with Heart Failure and Cardiogenic Shock, run by Stanford University at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 to 16 years
- Conditions the study is for
- Heart Failure, Cardiogenic Shock, Congenital Heart Disease
- What is being tested?
- Cardiohelp device (VA-ECMO), Heparin and Bivalirudin
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesUnited States
- Study dates
- 15 Apr 2025to Sep 2029
- Phase
- Phase 2
- 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 0 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 0 to 16 years of age (i.e., <17 years)
- Body weight 2.5 to 80 kilograms
- VA-ECMO use for primary cardiac failure using the Cardiohelp system.
- First ECMO run during the current hospitalization
- 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:
Show all 18Show fewer
- Gestationally-corrected age <37 weeks
- Bleeding or coagulopathy that is a contraindication to anticoagulation
- Irreversible renal, hepatic or lung failure
- Stroke or uncertain neurological status within the past 30 days
- Severely malnourished
- Use of an ECMO system other than the Cardiohelp
- VV-ECMO or ECMO for primary respiratory failure
- Goals of patient to focus on comfort measures only.
- Failure to separate from cardiopulmonary bypass
- Allergy or contraindication to receiving UFH or bivalirudin as a primary anticoagulant on ECMO.
- Patients who are pregnant or breastfeeding.
- Unable to undergo randomization within 30 hours following ECMO cannulation (randomized cohort only)
Who cannot join
None listed.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Children's Health Dallas
Dallas, Texas, 95235
Sirine Baltagi, MD, Sirine.Baltagi@UTSouthwestern.edu
- Recruiting
Duke University Hospital
Durham, North Carolina, 27710
Caroline Ozment, MD, caroline.ozment@duke.edu
- Recruiting
Cuimc/Nyph
New York, New York, 10032
Eva Cheung, MD, (212) 305-8458, ec2335@cumc.columbia.edu
- Recruiting
Lucile Packard Children's Hospital
Palo Alto, California, 94304
Kate Ryan, MD, 650-724-5554, kateryan@stanford.edu
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Michael McMullan, MD, 206-987-2015, michael.mcmullan@seattlechildrens.org
About this study
Official title: 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
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:
- 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.
- 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
Read more
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).
Read the detailed description
This is a multicenter clinical trial to evaluate the safety and effectiveness of the Cardiohelp System for up to 30 days of support in children with severe cardiac failure. The trial includes a secondary randomized study comparing heparin versus bivalirudin anticoagulation according to standard treatment protocols.
Despite more than 50 years of ECMO use that carries up to 50% mortality, no standalone ECMO device has ever received FDA clearance for pediatric ECMO. All ECMO use in children is off-label, which may contribute to substantial mortality and complications, as well as wide center-to-center variation in ECMO practices that lacks an evidence base. Additionally, while two anticoagulants (heparin and bivalirudin) are commonly used in ECMO circuits, the optimal choice remains unknown-specifically, which anticoagulant is associated with the fewest circuit clots and least bleeding.
This study, funded by an R01 clinical trials Orphan Grant from the FDA, seeks to change the current status quo. By collecting systematic safety and effectiveness data on the Cardiohelp Device, we aim to determine whether it is safe and effective enough to become the first standalone ECMO device to receive FDA clearance for up to 30 days of support in children. The FDA clearance decision will be based on how the Cardiohelp performs relative to several key performance benchmarks drawn from the published ECMO literature, which the FDA has jointly agreed upon. These benchmarks include overall survival without severe stroke, degree of hemolysis (red blood cell breakdown), frequency of circuit change due to thrombus or device malfunction, stroke rate, and kidney injury rate.
For the anticoagulant randomized trial, we will collect systematic data on clotting and bleeding complications associated with each anticoagulant. As a Phase II study, the goal is not to reach a final answer, but to design a Phase III (pivotal) trial that is as informative and efficient as possible for addressing this critical question in the field of ECMO.
Tertiary goals of the study are: (1) to determine the optimal performance range (i.e., device specifications) for the Cardiohelp device in children to inform an eventual FDA label and Instructions for Use (IFU); and (2) to provide the FDA with a predicate device to support FDA clearance of other ECMO systems under 510(k) regulation, as no predicate devices currently exist to support such regulatory comparisons.
- Being tested
- Cardiohelp device (VA-ECMO), Heparin, Bivalirudin
- Keywords
- blood thinner, ECMO, heart failure, bivalirudin, heparin, FDA regulation, pediatric medical devices, 510k clearance
- Medical subject headings
- Heart Failure, Shock, Cardiogenic, Heart Defects, Congenital, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiohelp device (VA-ECMO)Device
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.
HeparinDrug
Blood thinner that works by inactivating factor Xa that is administered as a continuous intravenous infusion.
BivalirudinDrug
Blood thinner that works by inhibiting thrombin directly that is administered as a continuous intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| Cardiohelp device managed according to a standardized guideline using heparin anticoagulation | Experimental | 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. Receives: Device: Cardiohelp device (VA-ECMO); Drug: Heparin |
| Cardiohelp device managed according to a standardized guideline using bivalirudin anticoagulation | Experimental | 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. Receives: Device: Cardiohelp device (VA-ECMO); Drug: Bivalirudin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival to 30 days, recovery, ventricular assist device implant or transplant in the absence of severe symptomatic stroke (primary device effectiveness)
Survival in the absence of severe symptomatic stroke to 30 days or decannulation for recovery, transplant or VAD implant. For patients with stroke definitely or probably related to ECMO, symptoms and severity will be determined at hospital discharge or 90 days, whichever is first.
Measured: 30 days of ECMO support or ECMO explant, whichever is earlier.
Symptomatic stroke (primary device safety)
For patients with stroke definitely or probably related to ECMO, the presence of stroke symptoms and its severity will be determined at hospital discharge or 90 days, whichever is first.
Measured: 30 days of ECMO support or ECMO explant, whichever is earlier.
Severe hemolysis (primary device safety)
Severe hemolysis as defined by the plasma-free hemoglobin level >100 mg/dL confirmed on repeat testing and outside the first 72 hours that is probably or definitely related to the device.
Measured: 30 days of ECMO support or ECMO explant, whichever is earlier.
Circuit change due to thrombus (primary device safety)
ECMO circuit change due primarily to thrombus that is probably or definitely related to the device.
Measured: 30 days of ECMO support or ECMO explant, whichever is earlier.
Circuit change due primarily to device malfunction (primary device safety)
Circuit change due primarily to device malfunction that is probably or definitely related to the device.
Measured: 30 days of ECMO support or ECMO explant, whichever is earlier.
Renal injury/failure (primary device safety)
renal injury/failure defined as three times the upper limit of normal or 3X baseline if the baseline is above the upper limit of normal.
Measured: 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)
Circuit-change free survival where the circuit is change is primarily due to thrombus and is definitely or probably related to the anticoagulant (primary safety endpoint for anticoagulation RCT)
Measured: 30 days of ECMO support or ECMO explant, whichever is earlier.
Bleeding
Total red blood cell transfusion volume in cc/kg/day probably or definitely related to the anticoagulant.
Measured: 30 days of ECMO support or ECMO explant, whichever is earlier.
Secondary outcomes (2)
Incidence of all serious adverse events
Incidence rate of all serious adverse events (per day of support)
Measured: 30 days
NHLBI bleeding and clotting score
The bleeding and clotting score as categorized by the ordinal 5-grade NHLBI score.
Measured: through 30 days of ECMO support or ECMO explant, whichever is earlier.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start15 Apr 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2029 (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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants receiving ECMO with the Cardiohelp Device for severe heart failure will managed/treated according to a standardized treatment and monitoring protocol that includes anticoagulation strategy, circuit change criteria, weaning guidelines, and recording of adverse events using standardized SAE definitions adapted from the ECMO-CENTRAL guidelines. While the Cardiohelp device trial is a single-arm cohort study, the FDA allowed us to randomize patients to blood thinner (heparin and bivalirudin). Both blood thinners are in common use in the US--providing the FDA with safety and effectiveness data on each of the two anticoagulants in at least \~25 participants. Please note: Because the data fields for clinicaltrials.gov make it easier to report more robust details for a randomized clinical trial, we have chosen to report the details of the RCT in this section, understanding that the FDA clearance study is running in the background as a single arm observational study.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Children's Hospital, Duke University, FDA Office of Orphan Products Development
- Responsible party
- Principal investigator, Christopher Almond, Stanford University
- Investigators
- Lynn Sleeper, ScD, Principal investigator, Boston Children's HospitalCaroline Ozment, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06080074
- Sponsor's protocol ID
- 72467
- Acronym
- TROLLEY
- Status last verified
- Jan 2026
- First submitted
- 6 Oct 2023
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06080074
- Acronym / sponsor ID
- TROLLEY / 72467
- Keywords
- blood thinner, ECMO, heart failure, bivalirudin, heparin, FDA regulation, pediatric medical devices, 510k clearance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Boston Children's Hospital, Duke University, FDA Office of Orphan Products Development
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 12 Oct 2023 (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.
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:
- 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.
- 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).
Detailed description
This is a multicenter clinical trial to evaluate the safety and effectiveness of the Cardiohelp System for up to 30 days of support in children with severe cardiac failure. The trial includes a secondary randomized study comparing heparin versus bivalirudin anticoagulation according to standard treatment protocols.
Despite more than 50 years of ECMO use that carries up to 50% mortality, no standalone ECMO device has ever received FDA clearance for pediatric ECMO. All ECMO use in children is off-label, which may contribute to substantial mortality and complications, as well as wide center-to-center variation in ECMO practices that lacks an evidence base. Additionally, while two anticoagulants (heparin and bivalirudin) are commonly used in ECMO circuits, the optimal choice remains unknown-specifically, which anticoagulant is associated with the fewest circuit clots and least bleeding.
This study, funded by an R01 clinical trials Orphan Grant from the FDA, seeks to change the current status quo. By collecting systematic safety and effectiveness data on the Cardiohelp Device, we aim to determine whether it is safe and effective enough to become the first standalone ECMO device to receive FDA clearance for up to 30 days of support in children. The FDA clearance decision will be based on how the Cardiohelp performs relative to several key performance benchmarks drawn from the published ECMO literature, which the FDA has jointly agreed upon. These benchmarks include overall survival without severe stroke, degree of hemolysis (red blood cell breakdown), frequency of circuit change due to thrombus or device malfunction, stroke rate, and kidney injury rate.
For the anticoagulant randomized trial, we will collect systematic data on clotting and bleeding complications associated with each anticoagulant. As a Phase II study, the goal is not to reach a final answer, but to design a Phase III (pivotal) trial that is as informative and efficient as possible for addressing this critical question in the field of ECMO.
Tertiary goals of the study are: (1) to determine the optimal performance range (i.e., device specifications) for the Cardiohelp device in children to inform an eventual FDA label and Instructions for Use (IFU); and (2) to provide the FDA with a predicate device to support FDA clearance of other ECMO systems under 510(k) regulation, as no predicate devices currently exist to support such regulatory comparisons.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants receiving ECMO with the Cardiohelp Device for severe heart failure will managed/treated according to a standardized treatment and monitoring protocol that includes anticoagulation strategy, circuit change criteria, weaning guidelines, and recording of adverse events using standardized SAE definitions adapted from the ECMO-CENTRAL guidelines. While the Cardiohelp device trial is a single-arm cohort study, the FDA allowed us to randomize patients to blood thinner (heparin and bivalirudin). Both blood thinners are in common use in the US--providing the FDA with safety and effectiveness data on each of the two anticoagulants in at least ~25 participants. Please note: Because the data fields for clinicaltrials.gov make it easier to report more robust details for a randomized clinical trial, we have chosen to report the details of the RCT in this section, understanding that the FDA clearance study is running in the background as a single arm observational study.
| Arm | Type | Receives |
|---|---|---|
| Cardiohelp device managed according to a standardized guideline using heparin anticoagulation | Experimental | Device: Cardiohelp device (VA-ECMO), Drug: HeparinParticipants 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. |
| Cardiohelp device managed according to a standardized guideline using bivalirudin anticoagulation | Experimental | Device: Cardiohelp device (VA-ECMO), Drug: BivalirudinParticipants 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. |
Who may qualify
- Ages
- 0 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (18 listed)
- Age 0 to 16 years of age (i.e., <17 years)
- Body weight 2.5 to 80 kilograms
- VA-ECMO use for primary cardiac failure using the Cardiohelp system.
- First ECMO run during the current hospitalization
- Written informed consent from the parent or legally appointed representative (LAR)
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 |
|---|---|---|
| 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. | Device | Cardiohelp device managed according to a standardized guideline using bivalirudin anticoagulation, Cardiohelp device managed according to a standardized guideline using heparin anticoagulation |
| HeparinBlood thinner that works by inactivating factor Xa that is administered as a continuous intravenous infusion. | Drug | Cardiohelp device managed according to a standardized guideline using heparin anticoagulation |
| BivalirudinBlood thinner that works by inhibiting thrombin directly that is administered as a continuous intravenous infusion. | Drug | Cardiohelp device managed according to a standardized guideline using bivalirudin anticoagulation |
Primary outcome
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.
Survival in the absence of severe symptomatic stroke to 30 days or decannulation for recovery, transplant or VAD implant. For patients with stroke definitely or probably related to ECMO, symptoms and severity will be determined at hospital discharge or 90 days, whichever is first.
Symptomatic stroke (primary device safety)
Time frame: 30 days of ECMO support or ECMO explant, whichever is earlier.
For patients with stroke definitely or probably related to ECMO, the presence of stroke symptoms and its severity will be determined at hospital discharge or 90 days, whichever is first.
Severe hemolysis (primary device safety)
Time frame: 30 days of ECMO support or ECMO explant, whichever is earlier.
Severe hemolysis as defined by the plasma-free hemoglobin level >100 mg/dL confirmed on repeat testing and outside the first 72 hours that is probably or definitely related to the device.
Circuit change due to thrombus (primary device safety)
Time frame: 30 days of ECMO support or ECMO explant, whichever is earlier.
ECMO circuit change due primarily to thrombus that is probably or definitely related to the device.
Circuit change due primarily to device malfunction (primary device safety)
Time frame: 30 days of ECMO support or ECMO explant, whichever is earlier.
Circuit change due primarily to device malfunction that is probably or definitely related to the device.
Renal injury/failure (primary device safety)
Time frame: 30 days of ECMO support or ECMO explant, whichever is earlier.
renal injury/failure defined as three times the upper limit of normal or 3X baseline if the baseline is above the upper limit of normal.
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.
Circuit-change free survival where the circuit is change is primarily due to thrombus and is definitely or probably related to the anticoagulant (primary safety endpoint for anticoagulation RCT)
Bleeding
Time frame: 30 days of ECMO support or ECMO explant, whichever is earlier.
Total red blood cell transfusion volume in cc/kg/day probably or definitely related to the anticoagulant.
2 secondary outcomes
Incidence of all serious adverse events
Time frame: 30 days
NHLBI bleeding and clotting score
Time frame: through 30 days of ECMO support or ECMO explant, whichever is earlier.
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 10 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
Lynn Sleeper, ScD principal investigator
Boston Children's Hospital
Caroline Ozment, MD principal investigator
Duke University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cardiohelp device (VA-ECMO), Heparin and Bivalirudin in people with Heart Failure and Cardiogenic Shock, run by Stanford University at 5 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 18 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: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 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.). The study lists 8 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 10 Aug 2026.