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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02968264
Ethics application status
Date submitted
4/01/2016
Date registered
18/11/2016

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
Timepoint [1] 0 0
2 years post-repair
Secondary outcome [1] 0 0
Number of patients undergoing various palliation procedures and surgical repair strategies
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
Cardiovascular mortality rate
Timepoint [2] 0 0
30 days and 2 years after repair
Secondary outcome [3] 0 0
Rate of palliation failure
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
Effect of palliation procedures on cardiac morphology
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
Post-operative restrictive physiology
Timepoint [5] 0 0
2 years
Secondary outcome [6] 0 0
Cardiac re-interventions
Timepoint [6] 0 0
2 years
Secondary outcome [7] 0 0
RV physiology and morphology following TOF pulmonary atresia repair
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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/06/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2022
Sample size
Target
Accrual to date
Final
1108
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
Indonesia
State/province [10] 0 0
Jakarta
Country [11] 0 0
Japan
State/province [11] 0 0
Okayama
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Seoul
Country [13] 0 0
Nepal
State/province [13] 0 0
Kathmandu
Country [14] 0 0
Russian Federation
State/province [14] 0 0
Novosibirsk
Country [15] 0 0
Saudi Arabia
State/province [15] 0 0
Makkah
Country [16] 0 0
Saudi Arabia
State/province [16] 0 0
Jeddah
Country [17] 0 0
Ukraine
State/province [17] 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
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02968264