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Comparison of Methods of Pulmonary Blood Flow Augmentation in Neonates: Shunt Versus Stent (The COMPASS Trial) (COMPASS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05268094
Recruitment Status : Recruiting
First Posted : March 7, 2022
Last Update Posted : November 23, 2022
Sponsor:
Collaborator:
Pediatric Heart Network
Information provided by (Responsible Party):
HealthCore-NERI

Brief Summary:
COMPASS is a prospective multicenter randomized interventional trial. Participants with ductal-dependent pulmonary blood flow will be randomized to receive either a systemic-to-pulmonary artery shunt or ductal artery stent. Block randomization will be performed by center and by single vs. two ventricle status. Participants will be followed through the first year of life.

Condition or disease Intervention/treatment Phase
Congenital Heart Disease in Children Device: Ductal Arterial Stent Procedure: Systemic-to-Pulmonary Artery Shunt Not Applicable

Detailed Description:
In neonates with ductal-dependent blood flow there remains valid uncertainty regarding the comparative benefits of ductal artery stent (DAS) with the traditional systemic-to-pulmonary artery shunt (SPS) palliation due to the lack of previous multicenter studies. COMPASS is a prospective multicenter randomized interventional trial where participants will be randomized to receive either an SPS or DAS to compare rates of a composite major morbidity/mortality endpoint in the first year of life. The study objectives are to perform an intention-to-treat analysis of participants' outcomes, and to describe the failure rate for neonatal candidates for DAS and the impact of this failure on the post-SPS course. Participants will be followed through the first year of life.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized to receive either an SPS or DAS. Overall randomization will be 1:1 to each treatment arm, with block randomization will be performed by center and by single vs. two ventricle status
Masking: None (Open Label)
Masking Description: Study staff and participants' families will be aware of treatment group due to the nature of the interventions.
Primary Purpose: Treatment
Official Title: Comparison of Methods of Pulmonary Blood Flow Augmentation in Neonates: Shunt Versus Stent (The COMPASS Trial)
Actual Study Start Date : June 2, 2022
Estimated Primary Completion Date : March 1, 2026
Estimated Study Completion Date : September 1, 2026

Arm Intervention/treatment
Experimental: Ductal Artery Stent
Transcatheter ductal artery shunt will be placed by the interventional team. Drug-eluting coronary stent brand, length, and diameter are determined by the interventional team.
Device: Ductal Arterial Stent
Drug-eluting ductal arterial stents will be placed by transcatheter method.
Other Names:
  • Medtronic Resolute Onyx
  • Boston Scientific Promus Elite/Premier
  • Boston Scientific Synergy
  • Cordis Elunir
  • Abbott Xience

Experimental: Systemic-to-Pulmonary Artery Shunt
Surgical systemic-to-pulmonary artery shunt performed by the interventional team. SPS diameter, length, and material will be determined by the surgeon performing the intervention.
Procedure: Systemic-to-Pulmonary Artery Shunt
A surgical connection will be made between a systemic artery and the pulmonary artery.




Primary Outcome Measures :
  1. Morbidity and/or Mortality Endpoint [ Time Frame: 1 year ]
    Rates of a composite major morbidity and/or mortality endpoint in the first year of life will be compared between neonates with ductal-dependent pulmonary blood flow randomized to receive either DAS or SPS as the initial palliation.


Secondary Outcome Measures :
  1. Global Rank Score [ Time Frame: 1 year ]
    All participants will be assigned a Global Rank Score, which is a rank based on a pre-specified hierarchical ranking of outcomes. This combines various endpoints into a single quantifiable endpoint with weighting of the severity of the component endpoints, and allows for the inclusion of endpoints of different forms. Global rank scores will range from 1-7.

  2. Freedom from Adverse Events [ Time Frame: 1 year ]
    Safety, defined as freedom from procedural adverse events and complications, will be tracked and evaluated.

  3. Days Alive out of Hospital [ Time Frame: 1 year ]
    Days alive out of the hospital represents a patient-centered outcome, and functions as a composite endpoint.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Day to 30 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Neonates with Congenital Heart Disease (CHD) and ductal-dependent pulmonary blood flow requiring only a stable source of pulmonary blood flow as the initial palliation, for whom the clinical decision is made at the enrolling center that this is best achieved by either DAS or SPS.
  2. Age ≤ 30 days at time of index procedure (DAS or SPS).

Exclusion Criteria:

  • 1. Any patient for whom the clinical decision at the enrolling center is that an initial intervention other than DAS or SPS is indicated (e.g., Right Ventricle-Pulmonary Artery (RV-PA) conduit, Right Ventricular Outflow Tract (RVOT) stent, primary complete anatomic repair, etc.).

    2. Pulmonary Atresia with Intact Ventricular Septum (PA/IVS) where Right Ventricle (RV) decompression is planned.

    3. Presence of MAPCAs: defined as an aortopulmonary collateral that is expected to require unifocalization.

    4. Non-confluent Pulmonary Arteries (i.e., isolated Pulmonary Artery (PA) of ductal origin).

    5. Acutely jeopardized branch Pulmonary Arteries (>75% narrowing of proximal PA based on screening cross sectional imaging [Computed Tomography Angiography (CTA) or cardiovascular Magnetic Resonance (cMR)]).

    6. Bilateral Patent Ductus Arteriosis (PDA). 7. Patient who, at the time of enrollment, is deemed not to be a candidate for eventual Glenn or Complete Surgical Repair (CSR) for any reason.

    8. Birth weight <2.0 kg. 9. Gestational age <34 weeks at birth. 10. Patient for whom additional intervention is expected concomitant with, or prior to, DAS or SPS (e.g., atrial septostomy, aortic arch intervention, or RV outflow tract intervention) - except for branch PA arterioplasty or stent/balloon angioplasty.

    11. Major co-morbidities which, in the opinion of the investigator, would negatively alter expected 1-year survival (e.g., intracranial hemorrhage, renal failure, etc.).

    12. Specific known genetic anomaly which, in the opinion of the investigator, would be expected to significantly alter clinical course in the first year of life (e.g., Trisomy 13/18, CHARGE, VACTERL).

    13. Patient who does not plan to return to the enrolling center or another participating center for Glenn/CSR.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05268094


Contacts
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Contact: Allison Crosby-Thompson 339-215-6593 acrosby-thompson@healthcore.com

Locations
Show Show 22 study locations
Sponsors and Collaborators
HealthCore-NERI
Pediatric Heart Network
Investigators
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Study Chair: Christopher Petit, MD Columbia University
Study Chair: Andrew Glatz, MD Washington University School of Medicine
Study Chair: Sara Pasquali, MD University of Michigan
Study Chair: Jenna Romano, MD University of Michigan
Study Chair: Jeffrey Zampi, MD University of Michigan
Additional Information:
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Responsible Party: HealthCore-NERI
ClinicalTrials.gov Identifier: NCT05268094    
Other Study ID Numbers: PHNCOMPASS
First Posted: March 7, 2022    Key Record Dates
Last Update Posted: November 23, 2022
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All individual participant data collected by the Data Coordinating Center will be shared after posting of results and main study results publication.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Protocol and Informed Consent Form will be shared within 12 months of publication of study results. Public Use Dataset will be made available after publication, timeframe to be decided.
Access Criteria: Protocol and Informed Consent Form will be made available with results on clinicaltrials.gov. Public Use Dataset will be available on the Pediatric Heart Network public website and may be used in accordance with Pediatric Heart Network governance.
URL: https://www.pediatricheartnetwork.org/login/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by HealthCore-NERI:
Congenital Heart Disease
Ductal Dependent Pulmonary Blood Flow
Ductal Artery Shunt
Systemic-to-Pulmonary Artery Shunt
Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities