Congenital Heart Disease Clinical Trial
— TOF-LIFEOfficial title:
Tetralogy of Fallot for Life
Verified date | December 2022 |
Source | Population Health Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 1108 |
Est. completion date | July 1, 2022 |
Est. primary completion date | March 15, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 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 |
Country | Name | City | State |
---|---|---|---|
Australia | Royal Children's Hospital | Parkville | Victoria |
Canada | Hospital for Sick Children | Toronto | Ontario |
China | Beijing Fuwai Hospital | Beijing | |
China | West China Hospital | Chengdu | Sichuan |
China | Guangdong Cardiovascular Institute | Guangdong | |
China | Guangzhou Women and Children's Medical Center | Guangdong | |
China | Shanghai Children's Medical Centre | Shanghai | |
China | Shanghai Xinhua Hospital | Shanghai | |
India | Kokilaben Dhirubhai Ambani Hospital & Medical Research Institutev | Mumbai | |
India | Fortis Escorts Heart Institute | New Delhi | Delhi |
Indonesia | National Cardiovascular Center Harapan Kita | Jakarta | |
Japan | Okayama University Hospital | Okayama | |
Korea, Republic of | Asan Medical Center | Seoul | |
Nepal | Manmohan Cardiothoracic Vascular and Transplant Center | Kathmandu | |
Russian Federation | Academician E.N. Meshalkin Research | Novosibirsk | |
Saudi Arabia | King Abdulaziz University Hospital | Jeddah | Makkah |
Saudi Arabia | King Faisal Specialist Hospital and Research Centre - Jeddah | Jeddah | |
Ukraine | Children's Cardiac Center - Ukraine | Kyiv | |
United States | Morgan Stanley Children's Hospital | New York | New York |
United States | Nemours Children's Hospital | Orlando | Florida |
Lead Sponsor | Collaborator |
---|---|
Population Health Research Institute | The Hospital for Sick Children |
United States, Australia, Canada, China, India, Indonesia, Japan, Korea, Republic of, Nepal, Russian Federation, Saudi Arabia, Ukraine,
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. — View 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. — View 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. — View 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.
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 2 years post-repair | |
Secondary | 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. | 2 years | |
Secondary | Cardiovascular mortality rate | To determine the 30-day and 2 year cardiovascular mortality rate (for equivalent patients) after primary and staged repair. | 30 days and 2 years after repair | |
Secondary | Rate of palliation failure | To determine the rate of palliation failure following various palliation techniques | 2 years | |
Secondary | 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. | 2 years | |
Secondary | 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. | 2 years | |
Secondary | 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) | 2 years | |
Secondary | 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. | 2 years |
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