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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02968264
Registration number
NCT02968264
Ethics application status
Date submitted
4/01/2016
Date registered
18/11/2016
Date last updated
21/12/2022
Titles & IDs
Public title
Tetralogy of Fallot for Life
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Scientific title
Tetralogy of Fallot for Life
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Secondary ID [1]
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TOF-LIFE 2.0 2015-06-11
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Universal Trial Number (UTN)
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Trial acronym
TOF-LIFE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Tetralogy of Fallot
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Congenital Heart Disease
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Congenital Heart Defect
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
TOF participants - Tetralogy of fallot patients at any age
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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RV physiology and morphology
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Assessment method [1]
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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.
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Timepoint [1]
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2 years post-repair
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Secondary outcome [1]
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Number of patients undergoing various palliation procedures and surgical repair strategies
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Assessment method [1]
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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.
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Timepoint [1]
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2 years
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Secondary outcome [2]
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Cardiovascular mortality rate
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Assessment method [2]
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To determine the 30-day and 2 year cardiovascular mortality rate (for equivalent patients) after primary and staged repair.
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Timepoint [2]
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30 days and 2 years after repair
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Secondary outcome [3]
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Rate of palliation failure
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Assessment method [3]
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To determine the rate of palliation failure following various palliation techniques
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Timepoint [3]
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2 years
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Secondary outcome [4]
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Effect of palliation procedures on cardiac morphology
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Assessment method [4]
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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.
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Timepoint [4]
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2 years
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Secondary outcome [5]
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Post-operative restrictive physiology
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Assessment method [5]
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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.
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Timepoint [5]
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2 years
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Secondary outcome [6]
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Cardiac re-interventions
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Assessment method [6]
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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)
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Timepoint [6]
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2 years
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Secondary outcome [7]
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RV physiology and morphology following TOF pulmonary atresia repair
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Assessment method [7]
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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.
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Timepoint [7]
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2 years
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Eligibility
Key inclusion criteria
- TOF with RVOT stenosis. TOF is defined as anterio-cephalad deviation of the
ventricular outlet septum with no more than 50% aortic override and a single outflow
VSD.
- TOF with pulmonary atresia and confluent pulmonary arteries.
- Admitted with intent to treat (i.e. patient planned to undergo a primary or staged
repair).
- Patients with coronary artery anomalies, right aortic arch, and 22q11 deletion may be
included
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- TOF with absent pulmonary valve
- Other major cardiac anomalies such as AVSD, multiple VSDs, right atrial isomerism, and
MAPCAs. In this instance, the definition of MAPCAs does not include dilated bronchial
collateral arteries.
- Unbalanced ventricles precluding biventricular repair
- Major genetic abnormalities/syndromes e.g. trisomy 13,18, and 21
- Major extra cardiac anomalies e.g. diaphragmatic hernia, omphalocele, absent sternum,
cerebral palsy
- Infective endocarditis as an indication for intra-cardiac repair
- Stroke in the last 30 days prior to palliation or intra-cardiac repair
- Known diagnosis of HIV or hepatitis B
- Any previous cardiac procedures
- Patient's circumstance that precludes completion of follow-up telephone call and/or
obtaining information from the 2-year cardiology follow-up
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/06/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2022
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Sample size
Target
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Accrual to date
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Final
1108
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Royal Children's Hospital - Parkville
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Recruitment postcode(s) [1]
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3052 - Parkville
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Florida
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Country [2]
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United States of America
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State/province [2]
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New York
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Country [3]
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Canada
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State/province [3]
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Ontario
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Country [4]
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China
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State/province [4]
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Sichuan
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Country [5]
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China
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State/province [5]
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Beijing
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Country [6]
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China
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State/province [6]
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Guangdong
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Country [7]
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China
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State/province [7]
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Shanghai
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Country [8]
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India
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State/province [8]
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Delhi
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Country [9]
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India
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State/province [9]
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Mumbai
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Country [10]
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Indonesia
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State/province [10]
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Jakarta
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Country [11]
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Japan
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State/province [11]
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Okayama
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Country [12]
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Korea, Republic of
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State/province [12]
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Seoul
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Country [13]
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Nepal
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State/province [13]
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Kathmandu
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Country [14]
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Russian Federation
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State/province [14]
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Novosibirsk
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Country [15]
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Saudi Arabia
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State/province [15]
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Makkah
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Country [16]
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Saudi Arabia
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State/province [16]
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Jeddah
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Country [17]
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Ukraine
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State/province [17]
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Kyiv
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Funding & Sponsors
Primary sponsor type
Other
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Name
Population Health Research Institute
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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The Hospital for Sick Children
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02968264
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Trial related presentations / publications
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.
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.
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.
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.
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.
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Public notes
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Contacts
Principal investigator
Name
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Glen Van Arsdell, MD
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Address
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University of California, Los Angeles
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02968264
Download to PDF