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

NCT00115934 | Completed Results DMC

• 9 other identifiers: 194U01HL068270U01HL068269U01HL068279U01HL068281U01HL068285U01HL068288U01HL068290U01HL068292
• Study Type: interventional
• Target: 555
• Locations: 2 countries
• Sites: 13

Brief Summary

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.

Conditions

Heart Defects, Congenital

Outcome Measures

Primary Outcomes (1)

• 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 at 12 months

Secondary Outcomes (16)

• Proportion of Deaths or Heart Transplants Over Time From Randomization to the End of the Trial

  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)

  Measured post-Norwood, an average of 17 days post-Norwood

• Echocardiographic Measures of Heart Size and Function: RV End-diastolic Volume Indexed to BSA

  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

  Measured at 14 months of age

• Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA

  Measured post-Norwood, an average of 17 days post-Norwood

Study Arms (2)

MBTS

ACTIVE COMPARATOR

Blalock-Taussig pulmonary artery shunt

Procedure: Blalock-Taussig pulmonary artery shunt

RVPAS

ACTIVE COMPARATOR

Right ventricular to pulmonary artery shunt

Procedure: Right ventricular to pulmonary artery shunt

Interventions

Blalock-Taussig pulmonary artery shunt PROCEDURE

Performed at stage I palliative surgery for babies born with HLHS

Also known as: MBTS procedure

MBTS

Right ventricular to pulmonary artery shunt PROCEDURE

Performed at stage I palliative surgery for babies born with HLHS

Also known as: RV to PA or Sano procedure

RVPAS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Carelon Research: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Pediatric Heart Network: collaborator

Study Sites (13)

Children's Hospital of Los Angeles

Los Angeles, California, 90027, United States

Location

Alfred I. duPont Hospital for Children

Wilmington, Delaware, 19899, United States

Location

Cardiac Surgical Associates

St. Petersburg, Florida, 33709, United States

Location

Children's Healthcare of Atlanta at Egleston

Atlanta, Georgia, 30033, United States

Location

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

University of Michigan Health System/Mott Hospital

Ann Arbor, Michigan, 48109, United States

Location

Columbia College of Physicians and Surgeons

New York, New York, 10032, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (36)

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  PMID: 18954638 BACKGROUND

• 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.

  PMID: 21331516 RESULT

• 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.

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  PMID: 20505177 RESULT

• 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.

  PMID: 17308942 RESULT

• 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.

  PMID: 37866470 DERIVED

• 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.

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• Tabbutt S, Ghanayem N, Ravishankar C, Sleeper LA, Cooper DS, Frank DU, Lu M, Pizarro C, Frommelt P, Goldberg CS, Graham EM, Krawczeski CD, Lai WW, Lewis A, Kirsh JA, Mahony L, Ohye RG, Simsic J, Lodge AJ, Spurrier E, Stylianou M, Laussen P; Pediatric Heart Network Investigators. Risk factors for hospital morbidity and mortality after the Norwood procedure: A report from the Pediatric Heart Network Single Ventricle Reconstruction trial. J Thorac Cardiovasc Surg. 2012 Oct;144(4):882-95. doi: 10.1016/j.jtcvs.2012.05.019. Epub 2012 Jun 15.

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• Frommelt PC, Guey LT, Minich LL, Bhat M, Bradley TJ, Colan SD, Ensing G, Gorentz J, Heydarian H, John JB, Lai WW, Levine JC, Mahle WT, Miller SG, Ohye RG, Pearson GD, Shirali GS, Wong PC, Cohen MS; Pediatric Heart Network Investigators. Does initial shunt type for the Norwood procedure affect echocardiographic measures of cardiac size and function during infancy?: the Single Vventricle Reconstruction trial. Circulation. 2012 May 29;125(21):2630-8. doi: 10.1161/CIRCULATIONAHA.111.072694. Epub 2012 Apr 21.

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• Newburger JW, Sleeper LA, Bellinger DC, Goldberg CS, Tabbutt S, Lu M, Mussatto KA, Williams IA, Gustafson KE, Mital S, Pike N, Sood E, Mahle WT, Cooper DS, Dunbar-Masterson C, Krawczeski CD, Lewis A, Menon SC, Pemberton VL, Ravishankar C, Atz TW, Ohye RG, Gaynor JW; Pediatric Heart Network Investigators. Early developmental outcome in children with hypoplastic left heart syndrome and related anomalies: the single ventricle reconstruction trial. Circulation. 2012 May 1;125(17):2081-91. doi: 10.1161/CIRCULATIONAHA.111.064113. Epub 2012 Mar 28.

  PMID: 22456475 DERIVED

• Tweddell JS, Sleeper LA, Ohye RG, Williams IA, Mahony L, Pizarro C, Pemberton VL, Frommelt PC, Bradley SM, Cnota JF, Hirsch J, Kirshbom PM, Li JS, Pike N, Puchalski M, Ravishankar C, Jacobs JP, Laussen PC, McCrindle BW; Pediatric Heart Network Investigators. Intermediate-term mortality and cardiac transplantation in infants with single-ventricle lesions: risk factors and their interaction with shunt type. J Thorac Cardiovasc Surg. 2012 Jul;144(1):152-9. doi: 10.1016/j.jtcvs.2012.01.016. Epub 2012 Feb 15.

  PMID: 22341427 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Blalock-Taussig Procedure

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Anastomosis, Surgical; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Cardiovascular Surgical Procedures

Limitations and Caveats

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.

Results Point of Contact

• Title: Lynn Sleeper, ScD
• Organization: New England Research Institutes

lsleeper@neriscience.com

617-972-3235

Study Officials

• Julie E Miller, MPH

  New England Research Institutes, Watertown, MA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2005
• First Posted: June 27, 2005
• Study Start: May 1, 2005
• Primary Completion: September 1, 2009
• Study Completion: October 1, 2009
• Last Updated: March 11, 2025
• Results First Posted: June 27, 2011

Record last verified: 2013-08

Locations

CA (1); US (12)