Heart Defects, CongenitalNCT00115934

Comparison of Two Types of Shunts in Infants With Single Ventricle Defect Undergoing Staged Reconstruction--Pediatric Heart Network

A study testing Blalock-Taussig pulmonary artery shunt and Right ventricular to pulmonary artery shunt in people with Heart Defects, Congenital, run by Carelon Research at 13 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Heart Defects, Congenital
What is being tested?: Blalock-Taussig pulmonary artery shunt and Right ventricular to pulmonary artery shunt
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 555 participants
Where: 13 sitesin 2 countries
Study dates: May 2005to Oct 2009
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Diagnosis of hypoplastic left heart syndrome or related single, morphologic right ventricle anomaly
Planned Norwood procedure
Informed consent of parent(s) or legal guardian

Who cannot join

Single, morphologic left ventricle anomaly
Preoperative identification of anatomy rendering either an MBTS or an RV-to-PA shunt technically impossible
Any major congenital abnormality (i.e., congenital diaphragmatic hernia, tracheoesophageal fistula) or acquired extra-cardiac disorder (e.g., meconium aspiration with need for high frequency ventilation, persistent renal failure requiring dialysis) that, in the opinion of the investigator, could independently affect the likelihood of the subject meeting the primary endpoint

Trial locations and contacts

13 sites in 2 countries.

Country

City, postcode or hospital

13 sites in 2 countries

United States12 sites

University of Michigan Health System/Mott Hospital
Ann Arbor, Michigan, 48109
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, 30033
Children's Hospital Boston
Boston, Massachusetts, 02115
Medical University of South Carolina
Charleston, South Carolina, 29425
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Duke University Medical Center
Durham, North Carolina, 27710
Children's Hospital of Los Angeles
Los Angeles, California, 90027
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
Columbia College of Physicians and Surgeons
New York, New York, 10032
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Cardiac Surgical Associates
St. Petersburg, Florida, 33709
Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19899

Other trials in United States

Canada1 site

Hospital for Sick Children
Toronto, Ontario, M5G 1X8

Other trials in Canada

About this study

Official title: Trial of Right Ventricular Versus Modified Blalock-Taussig Shunt in Infants With Single Ventricle Defect Undergoing Staged Reconstruction (A Trial Conducted by the Pediatric Heart Network)

This trial will evaluate the efficacy and safety of the modified Blalock-Taussig shunt (MBTS) compared to the right ventricle to pulmonary artery (RV-to-PA) shunt; compare the effect of the MBTS to that of the RV-to-PA shunt on the incidence of death or cardiac transplantation at 12 months post randomization; and compare the effect of the two shunts on intensive care unit (ICU) morbidity, unintended cardiovascular interventional procedures, right ventricular function, tricuspid valve regurgitation, pulmonary artery growth, and neurodevelopmental outcome.

Read the detailed description

BACKGROUND:

Hypoplastic left heart syndrome (HLHS) and related single right ventricle anomalies are the highest risk congenital cardiovascular malformations. Surgical repair begins with the Norwood procedure during the newborn period, a stage II procedure at 4 to 6 months of age, and Fontan procedure at 18 to 36 months. The Norwood procedure remains one of the highest risk procedures in congenital heart surgery. A few small nonrandomized studies of a novel approach to the Norwood procedure have reported improved outcomes. This new approach uses a RV-to-PA shunt to provide pulmonary blood flow rather than the standard MBTS. This multi-center, randomized clinical trial will evaluate early and intermediate-term outcomes for patients undergoing a Norwood procedure with either the RV-to-PA shunt or the MBTS.

This study has been approved by the Institutional Review/Research Ethics Boards of all participating clinical centers:

Hospital for Sick Children, Toronto, Canada

Children's Hospital Boston, Boston, MA

Columbia College of Physicians and Surgeons, New York, NY

Children's Hospital of Philadelphia, Philadelphia, PA

Duke University Medical Center, Durham, NC

Brody School of Medicine at East Carolina University, Greenville, NC

Wake Forest Baptist Medical Center, Winston Salem, NC

Medical University of South Carolina, Charleston, SC

Children's Hospital of Wisconsin, Milwaukee, WI

University of Michigan, Ann Arbor, MI

Cincinnati Children's Hospital Medical Center, Cincinnati, OH

Children's Hospital of Los Angeles, Los Angeles, CA

Egleston Children's Hospital, Emory University, Atlanta, GA

Congenital Heart Institute of Florida, University of South Florida, St. Petersburg, FL

Alfred I. duPont Hospital for Children, Wilmington, DE

DESIGN NARRATIVE:

This is a prospective, randomized clinical trial of the RV-to-PA shunt versus MBTS in patients undergoing a Norwood procedure.

Conditions: Heart Defects, Congenital
Being tested: Blalock-Taussig pulmonary artery shunt, Right ventricular to pulmonary artery shunt
Medical subject headings: Heart Defects, Congenital

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Blalock-Taussig pulmonary artery shuntProcedure or surgery
Also called MBTS procedure
Performed at stage I palliative surgery for babies born with HLHS
Right ventricular to pulmonary artery shuntProcedure or surgery
Also called RV to PA or Sano procedure
Performed at stage I palliative surgery for babies born with HLHS

Study groups in NCT00115934
Study group	Role	What they receive
MBTS	Active comparator	Blalock-Taussig pulmonary artery shunt Receives: Procedure: Blalock-Taussig pulmonary artery shunt
RVPAS	Active comparator	Right ventricular to pulmonary artery shunt Receives: Procedure: Right ventricular to pulmonary artery shunt

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Patients Who Died or Received a Heart Transplant
The primary outcome was the proportion of patients who died or had cardiac transplantation 12 months after randomization.
Measured: Measured at 12 months

Secondary outcomes (16)

Proportion of Deaths or Heart Transplants Over Time From Randomization to the End of the Trial
This secondary outcome was the proportion of deaths or cardiac transplantation over time from randomization to the end of the trial.
Measured: From Randomization to the End of the Trial, an average of 32 months
Echocardiographic Measures of Heart Size and Function: Right Ventricle (RV) End-diastolic Volume Indexed to Body Surface Area (BSA)
Right ventricular end-diastolic volume indexed to BSA^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.
Measured: Measured post-Norwood, an average of 17 days post-Norwood
Echocardiographic Measures of Heart Size and Function: RV End-diastolic Volume Indexed to BSA
Right ventricular end-diastolic volume indexed to BSA^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.
Measured: Measured pre-stage II surgery, an average of 15 days pre-stage II surgery
Echocardiographic Measures of Heart Size and Function: RV End-diastolic Volume Indexed to BSA
Right ventricular end-diastolic volume indexed to BSA^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.
Measured: Measured at 14 months of age
Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA
Right ventricular end-systolic volume indexed to BSA. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.
Measured: Measured post-Norwood, an average of 17 days post-Norwood
Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA
Right ventricular end-systolic volume indexed to BSA^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.
Measured: Measured pre-stage II surgery, an average of 15 days pre-stage II surgery
Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA
Right ventricular end-systolic volume indexed to BSA^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.
Measured: Measured at 14 months of age
Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction
Right ventricular ejection fraction: 100 x (RV end-diastolic volume - RV end-systolic volume)/RV end-diastolic volume. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.
Measured: Measured post-Norwood, an average of 17 days post-Norwood
Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction
Right ventricular ejection fraction: 100 x (RV end-diastolic volume - RV end-systolic volume)/RV end-diastolic volume. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.
Measured: Measured pre-stage II surgery, an average of 15 days pre-stage II surgery
Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction
Right ventricular ejection fraction: 100 x (RV end-diastolic volume - RV end-systolic volume)/RV end-diastolic volume. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.
Measured: Measured at 14 months of age
Angiographic Findings: Left Pulmonary Artery Size
Diameter of distal left pulmonary artery. Angiograms were performed at the time points relative to the second palliative surgery (pre-Stage II).
Measured: Measured pre-stage II surgery, on average 26 days prior to stage II palliation
Angiographic Findings: Right Pulmonary Artery Size
Diameter of distal right pulmonary artery. Angiograms were performed at the time points relative to the second palliative surgery (pre-Stage II).
Measured: Measured pre-stage II surgery, on average 26 days prior to stage II palliation
Unintended Cardiovascular Interventional Procedures
Unintended cardiovascular procedures included balloon dilation of the shunt or branch pulmonary arteries, stent placement in the shunt or branch pulmonary arteries, shunt revision, crossover between MBTS and RVPAS shunt, balloon dilation, stent placement or surgical revisions of the neo-aorta, and pulmonary artery reconstructions, other than those undertaken as a standard component of the stage II procedure. The number of cardiovascular procedures was analyzed; trial participants may have had more than one unintended cardiovascular. procedure.
Measured: From Randomization to 12 months
Complications: Total Number Experienced During Norwood Hospitalization
Complications, reported as 'Other Adverse Events' in the safety section, are those adverse events that were not considered serious. Many normal peri-operative occurrences meet the standard criteria of an adverse event; therefore, for this trial a serious adverse event was (a) death, (b) acute shunt failure requiring intervention, (c) cardiac arrest requiring CPR and medications, (d) cardiopulmonary insufficiency requiring ECMO, (e) cardiovascular re-operation (unplanned), (f) necrotizing enterocolitis requiring laparotomy, and (g) any event considered by the study investigator as serious.
Measured: Norwood Hospitalization, an average of 36 days
Complications: Total Number Experienced From Norwood Discharge to Stage II Discharge
Complications, reported as 'Other Adverse Events' in the safety section, are those adverse events that were not considered serious. Many normal peri-operative occurrences meet the standard criteria of an adverse event; therefore, for this trial a serious adverse event was (a) death, (b) acute shunt failure requiring intervention, (c) cardiac arrest requiring CPR and medications, (d) cardiopulmonary insufficiency requiring ECMO, (e) cardiovascular re-operation (unplanned), (f) necrotizing enterocolitis requiring laparotomy, and (g) any event considered by the study investigator as serious.
Measured: From Norwood Discharge to Stage II discharge, an average of 4.2 months
Complications: Total Number Experienced From Stage II Discharge to 14 Months of Age
Complications, reported as 'Other Adverse Events' in the safety section, are those adverse events that were not considered serious. Many normal peri-operative occurrences meet the standard criteria of an adverse event; therefore, for this trial a serious adverse event was (a) death, (b) acute shunt failure requiring intervention, (c) cardiac arrest requiring CPR and medications, (d) cardiopulmonary insufficiency requiring ECMO, (e) cardiovascular re-operation (unplanned), (f) necrotizing enterocolitis requiring laparotomy, and (g) any event considered by the study investigator as serious.
Measured: From Stage II Discharge to 14 Months of Age, an average of 8.9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2005Oct 2009

First posted27 Jun 2005 (estimated)
Study startMay 2005
Primary completionSep 2009
Study completionOct 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (38)Papers the sponsor has linked to this study.
Other trials for Heart Defects, CongenitalStudies of the same condition, open and under way.
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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 555 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00115934
Sponsor's protocol ID: 194
Other IDs: U01HL068270, U01HL068269, U01HL068279, U01HL068281, U01HL068285, U01HL068288, U01HL068290, U01HL068292
Status last verified: Aug 2013
First submitted: 26 Jun 2005
Last updated: 11 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Ohye RG, Gaynor JW, Ghanayem NS, Goldberg CS, Laussen PC, Frommelt PC, Newburger JW, Pearson GD, Tabbutt S, Wernovsky G, Wruck LM, Atz AM, Colan SD, Jaggers J, McCrindle BW, Prakash A, Puchalski MD, Sleeper LA, Stylianou MP, Mahony L; Pediatric Heart Network Investigators. Design and rationale of a randomized trial comparing the Blalock-Taussig and right ventricle-pulmonary artery shunts in the Norwood procedure. J Thorac Cardiovasc Surg. 2008 Oct;136(4):968-75. doi: 10.1016/j.jtcvs.2008.01.013. Epub 2008 May 19.
PubMed 18954638
Johnson JN, Ansong AK, Li JS, Xu M, Gorentz J, Hehir DA, del Castillo SL, Lai WW, Uzark K, Pasquali SK. Celiac artery flow pattern in infants with single right ventricle following the Norwood procedure with a modified Blalock-Taussig or right ventricle to pulmonary artery shunt. Pediatr Cardiol. 2011 Apr;32(4):479-86. doi: 10.1007/s00246-011-9906-y. Epub 2011 Feb 18.
PubMed 21331516
Virzi L, Pemberton V, Ohye RG, Tabbutt S, Lu M, Atz TC, Barnard T, Dunbar-Masterson C, Ghanayem NS, Jacobs JP, Lambert LM, Lewis A, Pike N, Pizarro C, Radojewski E, Teitel D, Xu M, Pearson GD. Reporting adverse events in a surgical trial for complex congenital heart disease: the Pediatric Heart Network experience. J Thorac Cardiovasc Surg. 2011 Sep;142(3):531-7. doi: 10.1016/j.jtcvs.2010.11.052. Epub 2011 Mar 12.
PubMed 21397260
Atz AM, Travison TG, Williams IA, Pearson GD, Laussen PC, Mahle WT, Cook AL, Kirsh JA, Sklansky M, Khaikin S, Goldberg C, Frommelt M, Krawczeski C, Puchalski MD, Jacobs JP, Baffa JM, Rychik J, Ohye RG; Pediatric Heart Network Investigators. Prenatal diagnosis and risk factors for preoperative death in neonates with single right ventricle and systemic outflow obstruction: screening data from the Pediatric Heart Network Single Ventricle Reconstruction Trial( *). J Thorac Cardiovasc Surg. 2010 Dec;140(6):1245-50. doi: 10.1016/j.jtcvs.2010.05.022. Epub 2010 Jun 18.
PubMed 20561642
Ohye RG, Sleeper LA, Mahony L, Newburger JW, Pearson GD, Lu M, Goldberg CS, Tabbutt S, Frommelt PC, Ghanayem NS, Laussen PC, Rhodes JF, Lewis AB, Mital S, Ravishankar C, Williams IA, Dunbar-Masterson C, Atz AM, Colan S, Minich LL, Pizarro C, Kanter KR, Jaggers J, Jacobs JP, Krawczeski CD, Pike N, McCrindle BW, Virzi L, Gaynor JW; Pediatric Heart Network Investigators. Comparison of shunt types in the Norwood procedure for single-ventricle lesions. N Engl J Med. 2010 May 27;362(21):1980-92. doi: 10.1056/NEJMoa0912461.
PubMed 20505177
Ohye RG, Devaney EJ, Hirsch JC, Bove EL. The modified Blalock-Taussig shunt versus the right ventricle-to-pulmonary artery conduit for the Norwood procedure. Pediatr Cardiol. 2007 Mar-Apr;28(2):122-5. doi: 10.1007/s00246-006-1449-2. Epub 2007 Feb 16.
PubMed 17308942
Hill KD, Kang L, Wang Q, Newburger JW, Gaynor JW, Burns KM, Williams R, Trachtenberg F, McCrindle BW, Graham EM, Pizarro C, Ashfaq A, Souza A, Kuo JA, Ilardi D, Schumacher KR, Hong H, Goldberg CS; Pediatric Heart Network Investigators. Single-Ventricle Disease: Long-Term Outcomes and Global Morbidity in the Single Ventricle Reconstruction Trial. J Am Coll Cardiol. 2026 Jun 9;87(22):3114-3133. doi: 10.1016/j.jacc.2026.01.049. Epub 2026 Mar 11.
PubMed 41811273
Cnota JF, Chowdhury SM, Floh A, Gongwer R, Goot BH, Jacobs JP, Jolley MA, Kirmani S, LaPar DJ, Levine JC, Lewis AB, Pignatelli RH, Pizarro C, Slesnick TC, Thorsson T, Trachtenberg F, Truong DT, Newburger JW, Frommelt PC; Pediatric Heart Network Investigators. Tricuspid Regurgitation and Impact of Surgical Valve Intervention in the Single Ventricle Reconstruction Trial. Pediatr Cardiol. 2026 Feb 18. doi: 10.1007/s00246-025-04122-x. Online ahead of print.
PubMed 41706109
Mahle WT, Keesari R, Trachtenberg F, Newburger JW, Lim H, Edelson J, Jeewa A, Lal A, Kindel SJ, Burns KM, Lang S, Bainton J, Carboni M, Villa CR, Richmond M, Henderson H, Menteer J, Pizarro C, Goldberg CS. School age and adolescent heart failure following the Norwood procedure. J Heart Lung Transplant. 2024 Mar;43(3):453-460. doi: 10.1016/j.healun.2023.10.012. Epub 2023 Oct 20.
PubMed 37866470
Dolgner SJ, Tjoeng YL, Chan T. Analysis of the Single Ventricle Reconstruction Trial Using Restricted Mean Survival Time and Shunt Type Received. J Am Heart Assoc. 2022 Sep 20;11(18):e025978. doi: 10.1161/JAHA.122.025978. Epub 2022 Sep 8. No abstract available.
PubMed 36073629
Miller TA, Ghanayem NS, Newburger JW, McCrindle BW, Hu C, DeWitt AG, Cnota JF, Tractenberg FL, Pemberton VL, Wolf MJ, Votava-Smith JK, Fifer CG, Lambert LM, Shah A, Graham EM, Pizarro C, Jacobs JP, Miller SG, Minich LL; Pediatric Heart Network Investigators. Gestational Age, Birth Weight, and Outcomes Six Years After the Norwood Procedure. Pediatrics. 2019 May;143(5):e20182577. doi: 10.1542/peds.2018-2577. Epub 2019 Apr 12.
PubMed 30979811
Frommelt PC, Hu C, Trachtenberg F, Baffa JM, Boruta RJ, Chowdhury S, Cnota JF, Dragulescu A, Levine JC, Lu J, Mercer-Rosa L, Miller TA, Shah A, Slesnick TC, Stapleton G, Stelter J, Wong P, Newburger JW. Impact of Initial Shunt Type on Echocardiographic Indices in Children After Single Right Ventricle Palliations. Circ Cardiovasc Imaging. 2019 Feb;12(2):e007865. doi: 10.1161/CIRCIMAGING.118.007865.
PubMed 30755054
Mahle WT, Hu C, Trachtenberg F, Menteer J, Kindel SJ, Dipchand AI, Richmond ME, Daly KP, Henderson HT, Lin KY, McCulloch M, Lal AK, Schumacher KR, Jacobs JP, Atz AM, Villa CR, Burns KM, Newburger JW; Pediatric Heart Network Investigators. Heart failure after the Norwood procedure: An analysis of the Single Ventricle Reconstruction Trial. J Heart Lung Transplant. 2018 Jul;37(7):879-885. doi: 10.1016/j.healun.2018.02.009. Epub 2018 Feb 16.
PubMed 29571602
Newburger JW, Sleeper LA, Gaynor JW, Hollenbeck-Pringle D, Frommelt PC, Li JS, Mahle WT, Williams IA, Atz AM, Burns KM, Chen S, Cnota J, Dunbar-Masterson C, Ghanayem NS, Goldberg CS, Jacobs JP, Lewis AB, Mital S, Pizarro C, Eckhauser A, Stark P, Ohye RG; Pediatric Heart Network Investigators. Transplant-Free Survival and Interventions at 6 Years in the SVR Trial. Circulation. 2018 May 22;137(21):2246-2253. doi: 10.1161/CIRCULATIONAHA.117.029375. Epub 2018 Feb 1.
PubMed 29437119
Bucholz EM, Sleeper LA, Newburger JW. Neighborhood Socioeconomic Status and Outcomes Following the Norwood Procedure: An Analysis of the Pediatric Heart Network Single Ventricle Reconstruction Trial Public Data Set. J Am Heart Assoc. 2018 Feb 2;7(3):e007065. doi: 10.1161/JAHA.117.007065.
PubMed 29420218

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
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Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Trial of Right Ventricular Versus Modified Blalock-Taussig Shunt in Infants With Single Ventricle Defect Undergoing Staged Reconstruction (A Trial Conducted by the Pediatric Heart Network)
ClinicalTrials.gov ID: NCT00115934
Acronym / sponsor ID: 194
Conditions: Heart Defects, Congenital
Study type: Interventional
Recruitment status: Completed
Enrolment: 555 participants (actual)
Lead sponsor: Carelon ResearchUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), Pediatric Heart Network
Study start: May 2005
Primary completion: Sep 2009 (actual)
Study completion: Oct 2009 (actual)
First posted: 27 Jun 2005 (estimated)
Results: Posted 27 Jun 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

BACKGROUND:

This study has been approved by the Institutional Review/Research Ethics Boards of all participating clinical centers:

Hospital for Sick Children, Toronto, Canada

Children's Hospital Boston, Boston, MA

Columbia College of Physicians and Surgeons, New York, NY

Children's Hospital of Philadelphia, Philadelphia, PA

Duke University Medical Center, Durham, NC

Brody School of Medicine at East Carolina University, Greenville, NC

Wake Forest Baptist Medical Center, Winston Salem, NC

Medical University of South Carolina, Charleston, SC

Children's Hospital of Wisconsin, Milwaukee, WI

University of Michigan, Ann Arbor, MI

Cincinnati Children's Hospital Medical Center, Cincinnati, OH

Children's Hospital of Los Angeles, Los Angeles, CA

Egleston Children's Hospital, Emory University, Atlanta, GA

Congenital Heart Institute of Florida, University of South Florida, St. Petersburg, FL

Alfred I. duPont Hospital for Children, Wilmington, DE

DESIGN NARRATIVE:

This is a prospective, randomized clinical trial of the RV-to-PA shunt versus MBTS in patients undergoing a Norwood procedure.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
MBTS	Active comparator	Procedure: Blalock-Taussig pulmonary artery shuntBlalock-Taussig pulmonary artery shunt
RVPAS	Active comparator	Procedure: Right ventricular to pulmonary artery shuntRight ventricular to pulmonary artery shunt

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Diagnosis of hypoplastic left heart syndrome or related single, morphologic right ventricle anomaly
Planned Norwood procedure
Informed consent of parent(s) or legal guardian

Key exclusion criteria (3 listed)

Single, morphologic left ventricle anomaly
Preoperative identification of anatomy rendering either an MBTS or an RV-to-PA shunt technically impossible
Any major congenital abnormality (i.e., congenital diaphragmatic hernia, tracheoesophageal fistula) or acquired extra-cardiac disorder (e.g., meconium aspiration with need for high frequency ventilation, persistent renal failure requiring dialysis) that, in the opinion of the investigator, could independently affect the likelihood of the subject meeting the primary endpoint

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
Blalock-Taussig pulmonary artery shuntAlso: MBTS procedurePerformed at stage I palliative surgery for babies born with HLHS	Procedure or surgery	MBTS
Right ventricular to pulmonary artery shuntAlso: RV to PA or Sano procedurePerformed at stage I palliative surgery for babies born with HLHS	Procedure or surgery	RVPAS

Primary outcome

Proportion of Patients Who Died or Received a Heart Transplant
Time frame: Measured at 12 months
The primary outcome was the proportion of patients who died or had cardiac transplantation 12 months after randomization.

16 secondary outcomes

Proportion of Deaths or Heart Transplants Over Time From Randomization to the End of the Trial
Time frame: From Randomization to the End of the Trial, an average of 32 months
Echocardiographic Measures of Heart Size and Function: Right Ventricle (RV) End-diastolic Volume Indexed to Body Surface Area (BSA)
Time frame: Measured post-Norwood, an average of 17 days post-Norwood
Echocardiographic Measures of Heart Size and Function: RV End-diastolic Volume Indexed to BSA
Time frame: Measured pre-stage II surgery, an average of 15 days pre-stage II surgery
Echocardiographic Measures of Heart Size and Function: RV End-diastolic Volume Indexed to BSA
Time frame: Measured at 14 months of age
Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA
Time frame: Measured post-Norwood, an average of 17 days post-Norwood
Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA
Time frame: Measured pre-stage II surgery, an average of 15 days pre-stage II surgery
Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA
Time frame: Measured at 14 months of age
Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction
Time frame: Measured post-Norwood, an average of 17 days post-Norwood
Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction
Time frame: Measured pre-stage II surgery, an average of 15 days pre-stage II surgery
Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction
Time frame: Measured at 14 months of age
Angiographic Findings: Left Pulmonary Artery Size
Time frame: Measured pre-stage II surgery, on average 26 days prior to stage II palliation
Angiographic Findings: Right Pulmonary Artery Size
Time frame: Measured pre-stage II surgery, on average 26 days prior to stage II palliation
Unintended Cardiovascular Interventional Procedures
Time frame: From Randomization to 12 months
Complications: Total Number Experienced During Norwood Hospitalization
Time frame: Norwood Hospitalization, an average of 36 days
Complications: Total Number Experienced From Norwood Discharge to Stage II Discharge
Time frame: From Norwood Discharge to Stage II discharge, an average of 4.2 months
Complications: Total Number Experienced From Stage II Discharge to 14 Months of Age
Time frame: From Stage II Discharge to 14 Months of Age, an average of 8.9 months

Results and safety

Results posted to the registry on 27 Jun 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MBTS	279	275
RVPAS	276	274

Primary outcome: Proportion of Patients Who Died or Received a Heart Transplant

Time frame: Measured at 12 months. Number. Unit: Participants

Measure	MBTS n = 275	RVPAS n = 274
Value	100	72

MBTS vs RVPAS: Risk Difference (RD): -10.1 (95% CI -17.8 to -2.4), p = 0.013, Fisher Exact

Population analysed: 555 subjects were enrolled in the study; 5 of these subjects were excluded from analyses because a Norwood procedure was not performed; 1 subject was excluded because the subject withdrew before the 12-month follow-up, 12-month status was unknown. The data were analyzed on an intention to treat basis, subjects were analyzed as randomized.

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MBTS	146 of 275 (53.1%)	249 of 275 (90.5%)	Not reported
RVPAS	112 of 274 (40.9%)	251 of 274 (91.6%)	Not reported

Limitations and caveats (from the sponsor): As in all surgical trials comparing two operations, it was not possible to blind the personnel caring for the subjects to the intervention. However, the components of the primary endpoint, death and transplantation, are discrete objective events.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 18954638Ohye RG, Gaynor JW, Ghanayem NS, Goldberg CS, Laussen PC, Frommelt PC, Newburger JW, Pearson GD, Tabbutt S, Wernovsky G, Wruck LM, Atz AM, Colan SD, Jaggers J, McCrindle BW, Prakash A, Puchalski MD, Sleeper LA, Stylianou MP, Mahony L; Pediatric Heart Network Investigators. Design and rationale of a randomized trial comparing the Blalock-Taussig and right ventricle-pulmonary artery shunts in the Norwood procedure. J Thorac Cardiovasc Surg. 2008 Oct;136(4):968-75. doi: 10.1016/j.jtcvs.2008.01.013. Epub 2008 May 19.
Results publication: PubMed 21331516Johnson JN, Ansong AK, Li JS, Xu M, Gorentz J, Hehir DA, del Castillo SL, Lai WW, Uzark K, Pasquali SK. Celiac artery flow pattern in infants with single right ventricle following the Norwood procedure with a modified Blalock-Taussig or right ventricle to pulmonary artery shunt. Pediatr Cardiol. 2011 Apr;32(4):479-86. doi: 10.1007/s00246-011-9906-y. Epub 2011 Feb 18.
Results publication: PubMed 21397260Virzi L, Pemberton V, Ohye RG, Tabbutt S, Lu M, Atz TC, Barnard T, Dunbar-Masterson C, Ghanayem NS, Jacobs JP, Lambert LM, Lewis A, Pike N, Pizarro C, Radojewski E, Teitel D, Xu M, Pearson GD. Reporting adverse events in a surgical trial for complex congenital heart disease: the Pediatric Heart Network experience. J Thorac Cardiovasc Surg. 2011 Sep;142(3):531-7. doi: 10.1016/j.jtcvs.2010.11.052. Epub 2011 Mar 12.
Results publication: PubMed 20561642Atz AM, Travison TG, Williams IA, Pearson GD, Laussen PC, Mahle WT, Cook AL, Kirsh JA, Sklansky M, Khaikin S, Goldberg C, Frommelt M, Krawczeski C, Puchalski MD, Jacobs JP, Baffa JM, Rychik J, Ohye RG; Pediatric Heart Network Investigators. Prenatal diagnosis and risk factors for preoperative death in neonates with single right ventricle and systemic outflow obstruction: screening data from the Pediatric Heart Network Single Ventricle Reconstruction Trial( *). J Thorac Cardiovasc Surg. 2010 Dec;140(6):1245-50. doi: 10.1016/j.jtcvs.2010.05.022. Epub 2010 Jun 18.
Results publication: PubMed 20505177Ohye RG, Sleeper LA, Mahony L, Newburger JW, Pearson GD, Lu M, Goldberg CS, Tabbutt S, Frommelt PC, Ghanayem NS, Laussen PC, Rhodes JF, Lewis AB, Mital S, Ravishankar C, Williams IA, Dunbar-Masterson C, Atz AM, Colan S, Minich LL, Pizarro C, Kanter KR, Jaggers J, Jacobs JP, Krawczeski CD, Pike N, McCrindle BW, Virzi L, Gaynor JW; Pediatric Heart Network Investigators. Comparison of shunt types in the Norwood procedure for single-ventricle lesions. N Engl J Med. 2010 May 27;362(21):1980-92. doi: 10.1056/NEJMoa0912461.
Results publication: PubMed 17308942Ohye RG, Devaney EJ, Hirsch JC, Bove EL. The modified Blalock-Taussig shunt versus the right ventricle-to-pulmonary artery conduit for the Norwood procedure. Pediatr Cardiol. 2007 Mar-Apr;28(2):122-5. doi: 10.1007/s00246-006-1449-2. Epub 2007 Feb 16.
Derived from this study: PubMed 41811273Hill KD, Kang L, Wang Q, Newburger JW, Gaynor JW, Burns KM, Williams R, Trachtenberg F, McCrindle BW, Graham EM, Pizarro C, Ashfaq A, Souza A, Kuo JA, Ilardi D, Schumacher KR, Hong H, Goldberg CS; Pediatric Heart Network Investigators. Single-Ventricle Disease: Long-Term Outcomes and Global Morbidity in the Single Ventricle Reconstruction Trial. J Am Coll Cardiol. 2026 Jun 9;87(22):3114-3133. doi: 10.1016/j.jacc.2026.01.049. Epub 2026 Mar 11.
Derived from this study: PubMed 41706109Cnota JF, Chowdhury SM, Floh A, Gongwer R, Goot BH, Jacobs JP, Jolley MA, Kirmani S, LaPar DJ, Levine JC, Lewis AB, Pignatelli RH, Pizarro C, Slesnick TC, Thorsson T, Trachtenberg F, Truong DT, Newburger JW, Frommelt PC; Pediatric Heart Network Investigators. Tricuspid Regurgitation and Impact of Surgical Valve Intervention in the Single Ventricle Reconstruction Trial. Pediatr Cardiol. 2026 Feb 18. doi: 10.1007/s00246-025-04122-x. Online ahead of print.
Derived from this study: PubMed 37866470Mahle WT, Keesari R, Trachtenberg F, Newburger JW, Lim H, Edelson J, Jeewa A, Lal A, Kindel SJ, Burns KM, Lang S, Bainton J, Carboni M, Villa CR, Richmond M, Henderson H, Menteer J, Pizarro C, Goldberg CS. School age and adolescent heart failure following the Norwood procedure. J Heart Lung Transplant. 2024 Mar;43(3):453-460. doi: 10.1016/j.healun.2023.10.012. Epub 2023 Oct 20.
Derived from this study: PubMed 36073629Dolgner SJ, Tjoeng YL, Chan T. Analysis of the Single Ventricle Reconstruction Trial Using Restricted Mean Survival Time and Shunt Type Received. J Am Heart Assoc. 2022 Sep 20;11(18):e025978. doi: 10.1161/JAHA.122.025978. Epub 2022 Sep 8. No abstract available.
Derived from this study: PubMed 30979811Miller TA, Ghanayem NS, Newburger JW, McCrindle BW, Hu C, DeWitt AG, Cnota JF, Tractenberg FL, Pemberton VL, Wolf MJ, Votava-Smith JK, Fifer CG, Lambert LM, Shah A, Graham EM, Pizarro C, Jacobs JP, Miller SG, Minich LL; Pediatric Heart Network Investigators. Gestational Age, Birth Weight, and Outcomes Six Years After the Norwood Procedure. Pediatrics. 2019 May;143(5):e20182577. doi: 10.1542/peds.2018-2577. Epub 2019 Apr 12.
Derived from this study: PubMed 30755054Frommelt PC, Hu C, Trachtenberg F, Baffa JM, Boruta RJ, Chowdhury S, Cnota JF, Dragulescu A, Levine JC, Lu J, Mercer-Rosa L, Miller TA, Shah A, Slesnick TC, Stapleton G, Stelter J, Wong P, Newburger JW. Impact of Initial Shunt Type on Echocardiographic Indices in Children After Single Right Ventricle Palliations. Circ Cardiovasc Imaging. 2019 Feb;12(2):e007865. doi: 10.1161/CIRCIMAGING.118.007865.

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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. This study is not recruiting at the moment.

Julie E Miller, MPH principal investigator

New England Research Institutes, Watertown, MA

13 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Blalock-Taussig pulmonary artery shunt and Right ventricular to pulmonary artery shunt in people with Heart Defects, Congenital, run by Carelon Research at 13 sites in 2 countries.

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 3 inclusion and 3 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: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States, Canada. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Patients Who Died or Received a Heart Transplant (time frame: Measured at 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00115934, which also lists 38 linked publications.

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 11 Mar 2025.