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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02968264




Registration number
NCT02968264
Ethics application status
Date submitted
4/01/2016
Date registered
18/11/2016
Date last updated
18/09/2020

Titles & IDs
Public title
Tetralogy of Fallot for Life
Scientific title
Tetralogy of Fallot for Life
Secondary ID [1] 0 0
TOF-LIFE 2.0 2015-06-11
Universal Trial Number (UTN)
Trial acronym
TOF-LIFE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tetralogy of Fallot 0 0
Congenital Heart Disease 0 0
Congenital Heart Defect 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
TOF participants - Tetralogy of fallot patients at any age

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
RV physiology and morphology - 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.
Timepoint [1] 0 0
2 years post-repair
Secondary outcome [1] 0 0
Number of patients undergoing various palliation procedures and surgical repair strategies - 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.
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
Cardiovascular mortality rate - To determine the 30-day and 2 year cardiovascular mortality rate (for equivalent patients) after primary and staged repair.
Timepoint [2] 0 0
30 days and 2 years after repair
Secondary outcome [3] 0 0
Rate of palliation failure - To determine the rate of palliation failure following various palliation techniques
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
Effect of palliation procedures on cardiac morphology - 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.
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
Post-operative restrictive physiology - 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.
Timepoint [5] 0 0
2 years
Secondary outcome [6] 0 0
Cardiac re-interventions - 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)
Timepoint [6] 0 0
2 years
Secondary outcome [7] 0 0
RV physiology and morphology following TOF pulmonary atresia repair - 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.
Timepoint [7] 0 0
2 years

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
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Children's Hospital - Parkville
Recruitment postcode(s) [1] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
China
State/province [4] 0 0
Sichuan
Country [5] 0 0
China
State/province [5] 0 0
Beijing
Country [6] 0 0
China
State/province [6] 0 0
Guangdong
Country [7] 0 0
China
State/province [7] 0 0
Shanghai
Country [8] 0 0
India
State/province [8] 0 0
Delhi
Country [9] 0 0
India
State/province [9] 0 0
Mumbai
Country [10] 0 0
Korea, Republic of
State/province [10] 0 0
Seoul
Country [11] 0 0
Nepal
State/province [11] 0 0
Kathmandu
Country [12] 0 0
Russian Federation
State/province [12] 0 0
Novosibirsk
Country [13] 0 0
Saudi Arabia
State/province [13] 0 0
Makkah
Country [14] 0 0
Saudi Arabia
State/province [14] 0 0
Jeddah
Country [15] 0 0
Ukraine
State/province [15] 0 0
Kyiv

Funding & Sponsors
Primary sponsor type
Other
Name
Population Health Research Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Hospital for Sick Children
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT02968264
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Glen Van Arsdell, MD
Address 0 0
University of California, Los Angeles
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications