Tetralogy of Fallot for Life

Completed

Conditions studied: Tetralogy of Fallot, Congenital Heart Disease, Congenital Heart Defect

In brief

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.

Key facts

Study ID

NCT02968264

Run by

Population Health Research Institute

People needed

1108

Starts

2015-06-08

Expected to finish

2022-07-01

Last updated by the study team

2022-12-21

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Nemours Children's Hospital — Orlando, Florida, United States
• Morgan Stanley Children's Hospital — New York, New York, United States
• Royal Children's Hospital — Parkville, Victoria, Australia
• Hospital for Sick Children — Toronto, Ontario, Canada
• West China Hospital — Chengdu, Sichuan, China
• Beijing Fuwai Hospital — Beijing, China
• Guangzhou Women and Children's Medical Center — Guangdong, China
• Guangdong Cardiovascular Institute — Guangdong, China
• Shanghai Children's Medical Centre — Shanghai, China
• Shanghai Xinhua Hospital — Shanghai, China
• Fortis Escorts Heart Institute — New Delhi, National Capital Territory of Delhi, India
• Kokilaben Dhirubhai Ambani Hospital & Medical Research Institutev — Mumbai, India
• National Cardiovascular Center Harapan Kita — Jakarta, Indonesia
• Okayama University Hospital — Okayama, Japan
• Manmohan Cardiothoracic Vascular and Transplant Center — Kathmandu, Nepal
• Academician E.N. Meshalkin Research — Novosibirsk, Russia
• King Abdulaziz University Hospital — Jeddah, Mecca Region, Saudi Arabia
• King Faisal Specialist Hospital and Research Centre - Jeddah — Jeddah, Saudi Arabia
• Asan Medical Center — Seoul, South Korea
• Children's Cardiac Center - Ukraine — Kyiv, Ukraine

Full record on ClinicalTrials.gov

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