Tetralogy of Fallot for Life

NCT02968264 | Completed

• 1 other identifier: TOF-LIFE 2.0 2015-06-11
• Study Type: observational
• Target: 1,108
• Locations: 12 countries
• Sites: 20

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.

Conditions

Tetralogy of Fallot; Congenital Heart Disease; Congenital Heart Defect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Number of patients undergoing various palliation procedures and surgical repair strategies

  2 years

• Cardiovascular mortality rate

  30 days and 2 years after repair

• Rate of palliation failure

  2 years

• Effect of palliation procedures on cardiac morphology

  2 years

• Post-operative restrictive physiology

  2 years

Study Arms (1)

TOF participants

Tetralogy of fallot patients at any age

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

TOF patients of any age undergoing their first cardiac intervention. Please refer to the eligibility criteria for more details.

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

Sponsors & Collaborators

• Population Health Research Institute: lead
• The Hospital for Sick Children: collaborator

Study Sites (20)

Nemours Children's Hospital

Orlando, Florida, 32827, United States

Location

Morgan Stanley Children's Hospital

New York, New York, 10032, United States

Location

Royal Children's Hospital

Parkville, Victoria, 3052, Australia

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

West China Hospital

Chengdu, Sichuan, 610041, China

Location

Beijing Fuwai Hospital

Beijing, 100037, China

Location

Guangzhou Women and Children's Medical Center

Guangdong, 510623, China

Location

Guangdong Cardiovascular Institute

Guangdong, China

Location

Shanghai Children's Medical Centre

Shanghai, China

Location

Shanghai Xinhua Hospital

Shanghai, China

Location

Fortis Escorts Heart Institute

New Delhi, National Capital Territory of Delhi, 110025, India

Location

Kokilaben Dhirubhai Ambani Hospital & Medical Research Institutev

Mumbai, 400 053, India

Location

National Cardiovascular Center Harapan Kita

Jakarta, Indonesia

Location

Okayama University Hospital

Okayama, Japan

Location

Manmohan Cardiothoracic Vascular and Transplant Center

Kathmandu, 977, Nepal

Location

Academician E.N. Meshalkin Research

Novosibirsk, Russia

Location

King Abdulaziz University Hospital

Jeddah, Mecca Region, 21589, Saudi Arabia

Location

King Faisal Specialist Hospital and Research Centre - Jeddah

Jeddah, 21499, Saudi Arabia

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Children's Cardiac Center - Ukraine

Kyiv, Ukraine

Location

Related Publications (5)

• 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.

  PMID: 23087090 BACKGROUND

• 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.

  PMID: 20732501 BACKGROUND

• 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.

  PMID: 11041398 BACKGROUND

• 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.

  PMID: 24513776 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Tetralogy of Fallot; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Glen Van Arsdell, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Richard Whitlock, MD, PhD

  Population Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2016
• First Posted: November 18, 2016
• Study Start: June 8, 2015
• Primary Completion: March 15, 2022
• Study Completion: July 1, 2022
• Last Updated: December 21, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1); NE (1); JP (1); US (2); RU (1); CN (6); IN (2); ID (1); AU (1); SA (2); CA (1); KR (1)