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

Primary Purpose

Heart Defects, Congenital

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Blalock-Taussig pulmonary artery shunt
Right ventricular to pulmonary artery shunt
Sponsored by
Carelon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Defects, Congenital

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital of Los Angeles
  • Alfred I. duPont Hospital for Children
  • Cardiac Surgical Associates
  • Children's Healthcare of Atlanta at Egleston
  • Children's Hospital Boston
  • University of Michigan Health System/Mott Hospital
  • Columbia College of Physicians and Surgeons
  • Duke University Medical Center
  • Cincinnati Children's Hospital Medical Center
  • Children's Hospital of Philadelphia
  • Medical University of South Carolina
  • Children's Hospital of Wisconsin
  • Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

MBTS

RVPAS

Arm Description

Blalock-Taussig pulmonary artery shunt

Right ventricular to pulmonary artery shunt

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
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.
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.
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.
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.

Full Information

First Posted
June 26, 2005
Last Updated
March 22, 2016
Sponsor
Carelon Research
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Pediatric Heart Network
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1. Study Identification

Unique Protocol Identification Number
NCT00115934
Brief Title
Comparison of Two Types of Shunts in Infants With Single Ventricle Defect Undergoing Staged Reconstruction--Pediatric Heart Network
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carelon Research
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Pediatric Heart Network

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
555 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MBTS
Arm Type
Active Comparator
Arm Description
Blalock-Taussig pulmonary artery shunt
Arm Title
RVPAS
Arm Type
Active Comparator
Arm Description
Right ventricular to pulmonary artery shunt
Intervention Type
Procedure
Intervention Name(s)
Blalock-Taussig pulmonary artery shunt
Other Intervention Name(s)
MBTS procedure
Intervention Description
Performed at stage I palliative surgery for babies born with HLHS
Intervention Type
Procedure
Intervention Name(s)
Right ventricular to pulmonary artery shunt
Other Intervention Name(s)
RV to PA or Sano procedure
Intervention Description
Performed at stage I palliative surgery for babies born with HLHS
Primary Outcome Measure Information:
Title
Proportion of Patients Who Died or Received a Heart Transplant
Description
The primary outcome was the proportion of patients who died or had cardiac transplantation 12 months after randomization.
Time Frame
Measured at 12 months
Secondary Outcome Measure Information:
Title
Proportion of Deaths or Heart Transplants Over Time From Randomization to the End of the Trial
Description
This secondary outcome was the proportion of deaths or cardiac transplantation 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
Title
Echocardiographic Measures of Heart Size and Function: Right Ventricle (RV) End-diastolic Volume Indexed to Body Surface Area (BSA)
Description
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.
Time Frame
Measured post-Norwood, an average of 17 days post-Norwood
Title
Echocardiographic Measures of Heart Size and Function: RV End-diastolic Volume Indexed to BSA
Description
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.
Time Frame
Measured pre-stage II surgery, an average of 15 days pre-stage II surgery
Title
Echocardiographic Measures of Heart Size and Function: RV End-diastolic Volume Indexed to BSA
Description
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.
Time Frame
Measured at 14 months of age
Title
Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA
Description
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.
Time Frame
Measured post-Norwood, an average of 17 days post-Norwood
Title
Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA
Description
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.
Time Frame
Measured pre-stage II surgery, an average of 15 days pre-stage II surgery
Title
Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA
Description
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.
Time Frame
Measured at 14 months of age
Title
Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction
Description
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.
Time Frame
Measured post-Norwood, an average of 17 days post-Norwood
Title
Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction
Description
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.
Time Frame
Measured pre-stage II surgery, an average of 15 days pre-stage II surgery
Title
Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction
Description
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.
Time Frame
Measured at 14 months of age
Title
Angiographic Findings: Left Pulmonary Artery Size
Description
Diameter of distal left pulmonary artery. Angiograms were performed at the time points relative to the second palliative surgery (pre-Stage II).
Time Frame
Measured pre-stage II surgery, on average 26 days prior to stage II palliation
Title
Angiographic Findings: Right Pulmonary Artery Size
Description
Diameter of distal right pulmonary artery. Angiograms were performed at the time points relative to the second palliative surgery (pre-Stage II).
Time Frame
Measured pre-stage II surgery, on average 26 days prior to stage II palliation
Title
Unintended Cardiovascular Interventional Procedures
Description
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.
Time Frame
From Randomization to 12 months
Title
Complications: Total Number Experienced During Norwood Hospitalization
Description
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.
Time Frame
Norwood Hospitalization, an average of 36 days
Title
Complications: Total Number Experienced From Norwood Discharge to Stage II Discharge
Description
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.
Time Frame
From Norwood Discharge to Stage II discharge, an average of 4.2 months
Title
Complications: Total Number Experienced From Stage II Discharge to 14 Months of Age
Description
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.
Time Frame
From Stage II Discharge to 14 Months of Age, an average of 8.9 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of hypoplastic left heart syndrome or related single, morphologic right ventricle anomaly Planned Norwood procedure Informed consent of parent(s) or legal guardian Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie E Miller, MPH
Organizational Affiliation
New England Research Institutes, Watertown, MA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Alfred I. duPont Hospital for Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19899
Country
United States
Facility Name
Cardiac Surgical Associates
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Children's Healthcare of Atlanta at Egleston
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Children's Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Michigan Health System/Mott Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Columbia College of Physicians and Surgeons
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

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

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