<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02968264</url>
  </required_header>
  <id_info>
    <org_study_id>TOF-LIFE 2.0 2015-06-11</org_study_id>
    <nct_id>NCT02968264</nct_id>
  </id_info>
  <brief_title>Tetralogy of Fallot for Life</brief_title>
  <acronym>TOF-LIFE</acronym>
  <official_title>Tetralogy of Fallot for Life</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Population Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Hospital for Sick Children</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Population Health Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim is to conduct a prospective multi-centre international inception cohort study with an&#xD;
      enrollment goal of 3,000 TOF patients and 2 year follow-up post-repair. The proposed sample&#xD;
      size and methodology will result in statistically powerful results to allow for&#xD;
      evidence-based change to current TOF surgical practices.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Tetralogy of Fallot (TOF) is the most common cyanotic heart defect consisting of&#xD;
      7-10% of all congenital heart disease with an estimated annual global incidence rate of&#xD;
      38,000. It is fatal if untreated; only 50% of patients are alive at 1 year of age. Surgery&#xD;
      has dramatically improved the survival so that &gt;95% of repaired TOF children are alive by one&#xD;
      year. The initial justified enthusiasm for the benefit of surgical therapy are now tempered&#xD;
      by the findings of late sudden cardiac death secondary to right ventricular (RV) dysfunction.&#xD;
      The original trans-ventricular/trans-annular patching repair results in significant pulmonary&#xD;
      insufficiency which leads to RV dilation, subsequent functional tricuspid regurgitation,&#xD;
      atrial arrhythmias, and eventual RV failure and ventricular arrhythmias. In attempt to break&#xD;
      this cycle, an increasing number of patients are undergoing late pulmonary valve&#xD;
      implantation.&#xD;
&#xD;
      Recognizing that the RV adapts to stress signals has led to the idea that leaving mixed&#xD;
      residual stenosis and regurgitation may yield to an adaptive change that limits RV dilation&#xD;
      while still allowing for adequate cardiac output. Early attempts to limit pulmonary&#xD;
      insufficiency and RV damage involve minimal trans-annular patching or complete annulus&#xD;
      preservation (AP). Emerging data suggest that patients with a mixed lesion have improved&#xD;
      survival, so that 96.6% are alive at 25-years in comparison to 85-90% survival for the&#xD;
      conventional technique.&#xD;
&#xD;
      Preliminary Data: A review of data comparing AP to TAP repair at our institution (n=185, AP&#xD;
      repair=124, TAP=61) demonstrated that at 10-15 year follow-up those who received an AP repair&#xD;
      had smaller RV volumes and pulmonary regurgitant jet width. They were also seen to have&#xD;
      improved exercise capacity as measure by VO2 max tests. The AP technique also has been seen&#xD;
      to significantly decrease the risk of reoperation in comparison to TAP, 11% and 29%&#xD;
      respectively.&#xD;
&#xD;
      Current Problem: Although trans-ventricular VSD closure along with a TAP is known to result&#xD;
      in increased risk of long-term morbidity and mortality, it continues to be the predominant&#xD;
      repair strategy implemented globally according to STS/EACTS databases. Reasons for this are:&#xD;
&#xD;
        -  Trans-ventricular/TAP approach is technically easier than annulus preservation, which&#xD;
           often requires multiple pump runs&#xD;
&#xD;
        -  There is a fear of leaving too much obstruction&#xD;
&#xD;
        -  High quality evidence supporting one approach over the other is lacking.&#xD;
&#xD;
      Gaps in Literature&#xD;
&#xD;
        1. Most data on the impact of surgical strategy emerge from single centre experiences that&#xD;
           are retrospective and based on small patient population. This makes the results&#xD;
           difficult to standardize to the general TOF population.&#xD;
&#xD;
        2. Retrospective registry data published by STS and EACTS omit many crucial surgical and&#xD;
           clinical variables that can potentially impact outcomes.&#xD;
&#xD;
        3. None of the current evidence are based on anatomically matched/adjusted patients&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 8, 2015</start_date>
  <completion_date type="Actual">July 1, 2022</completion_date>
  <primary_completion_date type="Actual">March 15, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>RV physiology and morphology</measure>
    <time_frame>2 years post-repair</time_frame>
    <description>To determine the association between baseline morphology, surgical repair technique (various surgical strategies for VSD closure and managing the RVOT), and RV physiology and morphology at 2 years obtained from echocardiogram studies.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients undergoing various palliation procedures and surgical repair strategies</measure>
    <time_frame>2 years</time_frame>
    <description>To determine the pattern of palliation procedures (BT shunt, RVOT stent, or balloon dilation), surgical repair strategy (staged versus primary repair), and surgical repair technique (AP, minimal TAP, standard TAP) at participating centres.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular mortality rate</measure>
    <time_frame>30 days and 2 years after repair</time_frame>
    <description>To determine the 30-day and 2 year cardiovascular mortality rate (for equivalent patients) after primary and staged repair.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of palliation failure</measure>
    <time_frame>2 years</time_frame>
    <description>To determine the rate of palliation failure following various palliation techniques</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of palliation procedures on cardiac morphology</measure>
    <time_frame>2 years</time_frame>
    <description>To determine the possible effect of palliative procedures (BT shunts, balloon dilation, stent insertion) on cardiac morphology (growth of the infundibular chamber, the pulmonary annulus and PA branches' diameter) and subsequent repair technique.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative restrictive physiology</measure>
    <time_frame>2 years</time_frame>
    <description>To determine the relationship between repair technique/strategy and prevalence of postoperative restrictive physiology as defined by the presence of antegrade flow in pulmonary artery during atrial contraction on echocardiogram.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac re-interventions</measure>
    <time_frame>2 years</time_frame>
    <description>To determine the relationship between TOF repair strategy/technique on the incidence and prevalence of cardiac re-interventions (e.g. pulmonary valve implantation, RVOT stent insertion or balloon dilatation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RV physiology and morphology following TOF pulmonary atresia repair</measure>
    <time_frame>2 years</time_frame>
    <description>To determine the right ventricular morphological and physiological adaptations to severe pulmonary stenosis or regurgitation using repaired TOF pulmonary atresia as a model. For example RV/LV end diastolic and systolic diameter ratio. RV and LV wall thickness relation to outflow gradient obtained by echocardiogram studies.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1108</enrollment>
  <condition>Tetralogy of Fallot</condition>
  <condition>Congenital Heart Disease</condition>
  <condition>Congenital Heart Defect</condition>
  <arm_group>
    <arm_group_label>TOF participants</arm_group_label>
    <description>Tetralogy of fallot patients at any age</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        TOF patients of any age undergoing their first cardiac intervention. Please refer to the&#xD;
        eligibility criteria for more details.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  TOF with RVOT stenosis. TOF is defined as anterio-cephalad deviation of the&#xD;
             ventricular outlet septum with no more than 50% aortic override and a single outflow&#xD;
             VSD.&#xD;
&#xD;
          -  TOF with pulmonary atresia and confluent pulmonary arteries.&#xD;
&#xD;
          -  Admitted with intent to treat (i.e. patient planned to undergo a primary or staged&#xD;
             repair).&#xD;
&#xD;
          -  Patients with coronary artery anomalies, right aortic arch, and 22q11 deletion may be&#xD;
             included&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  TOF with absent pulmonary valve&#xD;
&#xD;
          -  Other major cardiac anomalies such as AVSD, multiple VSDs, right atrial isomerism, and&#xD;
             MAPCAs. In this instance, the definition of MAPCAs does not include dilated bronchial&#xD;
             collateral arteries.&#xD;
&#xD;
          -  Unbalanced ventricles precluding biventricular repair&#xD;
&#xD;
          -  Major genetic abnormalities/syndromes e.g. trisomy 13,18, and 21&#xD;
&#xD;
          -  Major extra cardiac anomalies e.g. diaphragmatic hernia, omphalocele, absent sternum,&#xD;
             cerebral palsy&#xD;
&#xD;
          -  Infective endocarditis as an indication for intra-cardiac repair&#xD;
&#xD;
          -  Stroke in the last 30 days prior to palliation or intra-cardiac repair&#xD;
&#xD;
          -  Known diagnosis of HIV or hepatitis B&#xD;
&#xD;
          -  Any previous cardiac procedures&#xD;
&#xD;
          -  Patient's circumstance that precludes completion of follow-up telephone call and/or&#xD;
             obtaining information from the 2-year cardiology follow-up&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Glen Van Arsdell, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Richard Whitlock, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Population Health Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nemours Children's Hospital</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32827</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Morgan Stanley Children's Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Children's Hospital</name>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <zip>3052</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital for Sick Children</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West China Hospital</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Fuwai Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100037</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangzhou Women and Children's Medical Center</name>
      <address>
        <city>Guangdong</city>
        <zip>510623</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangdong Cardiovascular Institute</name>
      <address>
        <city>Guangdong</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Children's Medical Centre</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Xinhua Hospital</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fortis Escorts Heart Institute</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110025</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kokilaben Dhirubhai Ambani Hospital &amp; Medical Research Institutev</name>
      <address>
        <city>Mumbai</city>
        <zip>400 053</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cardiovascular Center Harapan Kita</name>
      <address>
        <city>Jakarta</city>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Okayama University Hospital</name>
      <address>
        <city>Okayama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Manmohan Cardiothoracic Vascular and Transplant Center</name>
      <address>
        <city>Kathmandu</city>
        <zip>977</zip>
        <country>Nepal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Academician E.N. Meshalkin Research</name>
      <address>
        <city>Novosibirsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King Abdulaziz University Hospital</name>
      <address>
        <city>Jeddah</city>
        <state>Makkah</state>
        <zip>21589</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King Faisal Specialist Hospital and Research Centre - Jeddah</name>
      <address>
        <city>Jeddah</city>
        <zip>21499</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Cardiac Center - Ukraine</name>
      <address>
        <city>Kyiv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>China</country>
    <country>India</country>
    <country>Indonesia</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Nepal</country>
    <country>Russian Federation</country>
    <country>Saudi Arabia</country>
    <country>Ukraine</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Sarris GE, Comas JV, Tobota Z, Maruszewski B. Results of reparative surgery for tetralogy of Fallot: data from the European Association for Cardio-Thoracic Surgery Congenital Database. Eur J Cardiothorac Surg. 2012 Nov;42(5):766-74; discussion 774. doi: 10.1093/ejcts/ezs478.</citation>
    <PMID>23087090</PMID>
  </reference>
  <reference>
    <citation>Al Habib HF, Jacobs JP, Mavroudis C, Tchervenkov CI, O'Brien SM, Mohammadi S, Jacobs ML. Contemporary patterns of management of tetralogy of Fallot: data from the Society of Thoracic Surgeons Database. Ann Thorac Surg. 2010 Sep;90(3):813-9; discussion 819-20. doi: 10.1016/j.athoracsur.2010.03.110.</citation>
    <PMID>20732501</PMID>
  </reference>
  <reference>
    <citation>Gatzoulis MA, Balaji S, Webber SA, Siu SC, Hokanson JS, Poile C, Rosenthal M, Nakazawa M, Moller JH, Gillette PC, Webb GD, Redington AN. Risk factors for arrhythmia and sudden cardiac death late after repair of tetralogy of Fallot: a multicentre study. Lancet. 2000 Sep 16;356(9234):975-81. doi: 10.1016/S0140-6736(00)02714-8.</citation>
    <PMID>11041398</PMID>
  </reference>
  <reference>
    <citation>d'Udekem Y, Galati JC, Rolley GJ, Konstantinov IE, Weintraub RG, Grigg L, Ramsay JM, Wheaton GR, Hope S, Cheung MH, Brizard CP. Low risk of pulmonary valve implantation after a policy of transatrial repair of tetralogy of Fallot delayed beyond the neonatal period: the Melbourne experience over 25 years. J Am Coll Cardiol. 2014 Feb 18;63(6):563-8. doi: 10.1016/j.jacc.2013.10.011. Epub 2013 Oct 30.</citation>
    <PMID>24513776</PMID>
  </reference>
  <reference>
    <citation>Pondorfer P YT, Cheung M, Ashburn D, Manlhiot C, McCrindle B, Mertens L, Grosse-Wortmann L, Redington A, Van Arsdell G. Abstract 18833: Annulus Preservation Strategy Improves Late Outcomes in Tetralogy of Fallot: An Anatomical Equivalency Study. Circulation. 2014;130:A18833.</citation>
  </reference>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>January 4, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>December 20, 2022</last_update_submitted>
  <last_update_submitted_qc>December 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Heart Defects, Congenital</mesh_term>
    <mesh_term>Tetralogy of Fallot</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02968264
org study id: TOF-LIFE 2.0 2015-06-11
nct id: NCT02968264
lead sponsor: 
collaborator: 
has dmc: No
The aim is to conduct a prospective multi-centre international inception cohort study with an
      enrollment goal of 3,000 TOF patients and 2 year follow-up post-repair. The proposed sample
      size and methodology will result in statistically powerful results to allow for
      evidence-based change to current TOF surgical practices.
Background: Tetralogy of Fallot (TOF) is the most common cyanotic heart defect consisting of
      7-10% of all congenital heart disease with an estimated annual global incidence rate of
      38,000. It is fatal if untreated; only 50% of patients are alive at 1 year of age. Surgery
      has dramatically improved the survival so that >95% of repaired TOF children are alive by one
      year. The initial justified enthusiasm for the benefit of surgical therapy are now tempered
      by the findings of late sudden cardiac death secondary to right ventricular (RV) dysfunction.
      The original trans-ventricular/trans-annular patching repair results in significant pulmonary
      insufficiency which leads to RV dilation, subsequent functional tricuspid regurgitation,
      atrial arrhythmias, and eventual RV failure and ventricular arrhythmias. In attempt to break
      this cycle, an increasing number of patients are undergoing late pulmonary valve
      implantation.

      Recognizing that the RV adapts to stress signals has led to the idea that leaving mixed
      residual stenosis and regurgitation may yield to an adaptive change that limits RV dilation
      while still allowing for adequate cardiac output. Early attempts to limit pulmonary
      insufficiency and RV damage involve minimal trans-annular patching or complete annulus
      preservation (AP). Emerging data suggest that patients with a mixed lesion have improved
      survival, so that 96.6% are alive at 25-years in comparison to 85-90% survival for the
      conventional technique.

      Preliminary Data: A review of data comparing AP to TAP repair at our institution (n=185, AP
      repair=124, TAP=61) demonstrated that at 10-15 year follow-up those who received an AP repair
      had smaller RV volumes and pulmonary regurgitant jet width. They were also seen to have
      improved exercise capacity as measure by VO2 max tests. The AP technique also has been seen
      to significantly decrease the risk of reoperation in comparison to TAP, 11% and 29%
      respectively.

      Current Problem: Although trans-ventricular VSD closure along with a TAP is known to result
      in increased risk of long-term morbidity and mortality, it continues to be the predominant
      repair strategy implemented globally according to STS/EACTS databases. Reasons for this are:

        -  Trans-ventricular/TAP approach is technically easier than annulus preservation, which
           often requires multiple pump runs

        -  There is a fear of leaving too much obstruction

        -  High quality evidence supporting one approach over the other is lacking.

      Gaps in Literature

        1. Most data on the impact of surgical strategy emerge from single centre experiences that
           are retrospective and based on small patient population. This makes the results
           difficult to standardize to the general TOF population.

        2. Retrospective registry data published by STS and EACTS omit many crucial surgical and
           clinical variables that can potentially impact outcomes.

        3. None of the current evidence are based on anatomically matched/adjusted patients
observational model: Cohort
time perspective: Prospective
measure: RV physiology and morphology
time frame: 2 years post-repair
description: To determine the association between baseline morphology, surgical repair technique (various surgical strategies for VSD closure and managing the RVOT), and RV physiology and morphology at 2 years obtained from echocardiogram studies.
measure: Number of patients undergoing various palliation procedures and surgical repair strategies
time frame: 2 years
description: To determine the pattern of palliation procedures (BT shunt, RVOT stent, or balloon dilation), surgical repair strategy (staged versus primary repair), and surgical repair technique (AP, minimal TAP, standard TAP) at participating centres.
measure: Cardiovascular mortality rate
time frame: 30 days and 2 years after repair
description: To determine the 30-day and 2 year cardiovascular mortality rate (for equivalent patients) after primary and staged repair.
measure: Rate of palliation failure
time frame: 2 years
description: To determine the rate of palliation failure following various palliation techniques
measure: Effect of palliation procedures on cardiac morphology
time frame: 2 years
description: To determine the possible effect of palliative procedures (BT shunts, balloon dilation, stent insertion) on cardiac morphology (growth of the infundibular chamber, the pulmonary annulus and PA branches' diameter) and subsequent repair technique.
measure: Post-operative restrictive physiology
time frame: 2 years
description: To determine the relationship between repair technique/strategy and prevalence of postoperative restrictive physiology as defined by the presence of antegrade flow in pulmonary artery during atrial contraction on echocardiogram.
measure: Cardiac re-interventions
time frame: 2 years
description: To determine the relationship between TOF repair strategy/technique on the incidence and prevalence of cardiac re-interventions (e.g. pulmonary valve implantation, RVOT stent insertion or balloon dilatation)
measure: RV physiology and morphology following TOF pulmonary atresia repair
time frame: 2 years
description: To determine the right ventricular morphological and physiological adaptations to severe pulmonary stenosis or regurgitation using repaired TOF pulmonary atresia as a model. For example RV/LV end diastolic and systolic diameter ratio. RV and LV wall thickness relation to outflow gradient obtained by echocardiogram studies.
arm group label: TOF participants
description: Tetralogy of fallot patients at any age
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Glen Van Arsdell, MD
role: Principal Investigator
affiliation: University of California, Los Angeles
last name: Richard Whitlock, MD, PhD
role: Principal Investigator
affiliation: Population Health Research Institute
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
country: Canada
country: China
country: India
country: Indonesia
country: Japan
country: Korea, Republic of
country: Nepal
country: Russian Federation
country: Saudi Arabia
country: Ukraine
country: United States
citation: Sarris GE, Comas JV, Tobota Z, Maruszewski B. Results of reparative surgery for tetralogy of Fallot: data from the European Association for Cardio-Thoracic Surgery Congenital Database. Eur J Cardiothorac Surg. 2012 Nov;42(5):766-74; discussion 774. doi: 10.1093/ejcts/ezs478.
PMID: 23087090
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responsible party type: Sponsor
mesh term: Heart Diseases
mesh term: Heart Defects, Congenital
mesh term: Tetralogy of Fallot
sharing ipd: No