Back to results

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

Primary Purpose

Congenital Heart Disease in Children

Status

Recruiting

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Ductal Arterial Stent

Systemic-to-Pulmonary Artery Shunt

About this trial

This is an interventional treatment trial for Congenital Heart Disease in Children focused on measuring Congenital Heart Disease, Ductal Dependent Pulmonary Blood Flow, Ductal Artery Shunt, Systemic-to-Pulmonary Artery Shunt

Eligibility Criteria

1 Day - 30 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
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.

Sites / Locations

University of AlabamaRecruiting
Phoenix Children's HospitalRecruiting
Children's Hospital Los Angeles
UCSF Benioff Children's HospitalsRecruiting
Stanford Children's HealthRecruiting
Children's Hospital of ColoradoRecruiting
Children's National Medical CenterRecruiting
Joe DiMaggio Children's HospitalRecruiting
Children's Healthcare of AtlantaRecruiting
Boston Children's HospitalRecruiting
University of MichiganRecruiting
Washington University School of MedicineRecruiting
New York Presbyterian Hospital/Columbia University Irving Medical CenterRecruiting
Levine Children's HospitalRecruiting
Cincinnati Children's Hospital Medical CenterRecruiting
Children's Hospital of PhiladelphiaRecruiting
University of Pittsburgh Medical CenterRecruiting
Medical University of South CarolinaRecruiting
Le Bonheur Children's Hospital
UT Southwestern Medical Center
Texas Children's HospitalRecruiting
Primary Children's HospitalRecruiting
Children's WisconsinRecruiting
Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Ductal Artery Stent

Systemic-to-Pulmonary Artery Shunt

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Morbidity and/or Mortality Endpoint

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

Global Rank Score

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.

Freedom from Adverse Events

Safety, defined as freedom from procedural adverse events and complications, will be tracked and evaluated.

Days Alive out of Hospital

Days alive out of the hospital represents a patient-centered outcome, and functions as a composite endpoint.

Full Information

NCT ID

NCT05268094

First Posted

January 19, 2022

Last Updated

April 12, 2023

Sponsor

Carelon Research

Collaborators

Pediatric Heart Network

1. Study Identification

Unique Protocol Identification Number

NCT05268094

Brief Title

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

Acronym

COMPASS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 2, 2022 (Actual)

Primary Completion Date

March 1, 2026 (Anticipated)

Study Completion Date

September 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Carelon Research

Collaborators

Pediatric Heart Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Congenital Heart Disease in Children

Keywords

Congenital Heart Disease, Ductal Dependent Pulmonary Blood Flow, Ductal Artery Shunt, Systemic-to-Pulmonary Artery Shunt

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ductal Artery Stent

Arm Type

Experimental

Arm Description

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.

Arm Title

Systemic-to-Pulmonary Artery Shunt

Arm Type

Experimental

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Ductal Arterial Stent

Other Intervention Name(s)

Medtronic Resolute Onyx, Boston Scientific Promus Elite/Premier, Boston Scientific Synergy, Cordis Elunir, Abbott Xience

Intervention Description

Drug-eluting ductal arterial stents will be placed by transcatheter method.

Intervention Type

Procedure

Intervention Name(s)

Systemic-to-Pulmonary Artery Shunt

Intervention Description

A surgical connection will be made between a systemic artery and the pulmonary artery.

Primary Outcome Measure Information:

Title

Morbidity and/or Mortality Endpoint

Description

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Global Rank Score

Description

Time Frame

1 year

Title

Freedom from Adverse Events

Description

Safety, defined as freedom from procedural adverse events and complications, will be tracked and evaluated.

Time Frame

1 year

Title

Days Alive out of Hospital

Description

Days alive out of the hospital represents a patient-centered outcome, and functions as a composite endpoint.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Day

Maximum Age & Unit of Time

30 Days

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Allison Crosby-Thompson

Phone

339-215-6593

allison.crosby-thompson@carelon.com

First Name & Middle Initial & Last Name or Official Title & Degree

Rachna Kumar

rachna.kumar@carelon.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christopher Petit, MD

Organizational Affiliation

Columbia University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Andrew Glatz, MD

Organizational Affiliation

Washington University School of Medicine

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Sara Pasquali, MD

Organizational Affiliation

University of Michigan

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Jenna Romano, MD

Organizational Affiliation

University of Michigan

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Jeffrey Zampi, MD

Organizational Affiliation

University of Michigan

Official's Role

Study Chair

Facility Information:

Facility Name

University of Alabama

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35233

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Krissie Hock

khock@peds.uab.edu

First Name & Middle Initial & Last Name & Degree

Mark Law, MD

Facility Name

Phoenix Children's Hospital

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85016

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jade Porche

jporche@phoenixchildrens.com

First Name & Middle Initial & Last Name & Degree

Joseph Graziano, MD

Facility Name

Children's Hospital Los Angeles

City

Los Angeles

State/Province

California

ZIP/Postal Code

90027

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Carly Weaver

cweaver@chla.usc.edu

First Name & Middle Initial & Last Name & Degree

Ram Subramanyan, MD, PhD

Facility Name

UCSF Benioff Children's Hospitals

City

Oakland

State/Province

California

ZIP/Postal Code

94609

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Disha Goel

disha.goel@ucsf.edu

First Name & Middle Initial & Last Name & Degree

Jeffery Meadows, MD

Facility Name

Stanford Children's Health

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sandra Moon

smoon3@stanford.edu

First Name & Middle Initial & Last Name & Degree

Lynn Peng, MD

Facility Name

Children's Hospital of Colorado

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Megyn Gordan

megyn.gordon@childrenscolorado.org

First Name & Middle Initial & Last Name & Degree

Michael DiMaria, MD

Facility Name

Children's National Medical Center

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20010

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alix Fetch

afetch@childrensnational.org

First Name & Middle Initial & Last Name & Degree

Tacy Downing, MD

Facility Name

Joe DiMaggio Children's Hospital

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33021

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kathleen Hathaway

KHathaway@mhs.net

First Name & Middle Initial & Last Name & Degree

Doris Alaby

dalaby@mhs.net

First Name & Middle Initial & Last Name & Degree

Peter Guyon, MD

Facility Name

Children's Healthcare of Atlanta

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Laura Price

Laura.Price@choa.org

First Name & Middle Initial & Last Name & Degree

Dennis Kim, MD, PhD

Facility Name

Boston Children's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Thomas Giorgio

thomas.giorgio@cardio.chboston.org

First Name & Middle Initial & Last Name & Degree

Simran

First Name & Middle Initial & Last Name & Degree

Nicola Maschietto, MD, PhD

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tammy Doman

tpaterso@med.umich.edu

First Name & Middle Initial & Last Name & Degree

Jeffrey Zampi, MD

Facility Name

Washington University School of Medicine

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Abigail Waldron

wabigail@wustl.edu

First Name & Middle Initial & Last Name & Degree

Mason Basler

basler@wustl.edu

First Name & Middle Initial & Last Name & Degree

Andrew Glatz, MD. MSCE

Facility Name

New York Presbyterian Hospital/Columbia University Irving Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rachel Weber

rw2727@cumc.columbia.edu

First Name & Middle Initial & Last Name & Degree

Christopher Petit, MD

Facility Name

Levine Children's Hospital

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28203

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Susan Bartos

susan.bartos@atriumhealth.org

First Name & Middle Initial & Last Name & Degree

Matthew Schwartz, MD

Facility Name

Cincinnati Children's Hospital Medical Center

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lauryn Dugan, MD

lauryn.dugan@cchmc.org

First Name & Middle Initial & Last Name & Degree

David Winlaw, MD

Facility Name

Children's Hospital of Philadelphia

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alekhya Nanduri

nanduria@chop.edu

First Name & Middle Initial & Last Name & Degree

Michael O'Byrne, MD, MSCE

Facility Name

University of Pittsburgh Medical Center

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Niklas Gerhart

gerhartne4@upmc.edu

First Name & Middle Initial & Last Name & Degree

Shannon Janzef

janzefsl@upmc.edu

First Name & Middle Initial & Last Name & Degree

Bryan Goldstein, MD

Facility Name

Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Layla Al Sarraf

alsarral@musc.edu

First Name & Middle Initial & Last Name & Degree

John Costello, MD, MPH

Facility Name

Le Bonheur Children's Hospital

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38105

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kathryn Carpenter

Kathryn.carpenter@lebonheur.org

First Name & Middle Initial & Last Name & Degree

Shyam K Sathanandam, MD

Facility Name

UT Southwestern Medical Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75235

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kara Lorduy

kara.lorduy@childrens.com

First Name & Middle Initial & Last Name & Degree

Glenda Moate

glenda.moate@childrens.com

First Name & Middle Initial & Last Name & Degree

Surendranath Veeram Reddy, MD

Facility Name

Texas Children's Hospital

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Thao (Debbie) Wu

ttwu@texaschildrens.org

First Name & Middle Initial & Last Name & Degree

Athar Qureshi, MD

Facility Name

Primary Children's Hospital

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84113

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Andrea Curless

andrea.curless@hsc.utah.edu

First Name & Middle Initial & Last Name & Degree

Dana Boucek, MD, MSCI

Facility Name

Children's Wisconsin

City

Wauwatosa

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jennifer Yauck

jyauck@chw.org

First Name & Middle Initial & Last Name & Degree

Susan Foerster, MD

Facility Name

Hospital for Sick Children

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 1X8

Country

Canada

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Martha Rolland

martha.rolland@sickkids.ca

First Name & Middle Initial & Last Name & Degree

Rajiv Chaturvedi, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

All individual participant data collected by the Data Coordinating Center will be shared after posting of results and main study results publication.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing URL

https://www.pediatricheartnetwork.org/login/

Links:

URL

https://www.pediatricheartnetwork.org/studies/

Description

Pediatric Heart Network Current Studies

Learn more about this trial

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

We'll reach out to this number within 24 hrs