Congenital Heart Disease Clinical Trial
— STARSIIOfficial title:
Sudden Cardiac Death in Congenital Heart Diseases With a Systemic Right Ventricle
NCT number | NCT03833843 |
Other study ID # | STARS |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 1, 2018 |
Est. completion date | September 1, 2019 |
Verified date | May 2021 |
Source | European Georges Pompidou Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
In complete transposition of the great arteries (TGA) with previous atrial switch repair, and congenitally corrected transposition of the great arteries (ccTGA), the morphological right ventricle and its tricuspid valve continue to support the systemic circulation. This results in late complications including including sudden death. This retrospective multicentric study aims to evaluate the prevalence of SCD in a contemporary population of patients with a systemic RV and identify specific risk factors for SCD and hemodynamically significant ventricular arrhythmia This registry records demographics, clinical, imaging data, electrophysiological and laboratory of patients with a sRV and a transposition of the great arteries Primary end points are defined by sudden cardiac death, near-miss sudden death, as well as sustained VT requiring defibrillation.
Status | Completed |
Enrollment | 1240 |
Est. completion date | September 1, 2019 |
Est. primary completion date | September 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility | Inclusion Criteria: - patients >16 years of age - sRV and a transposition of the great arteries (TGA or ccTGA) with "two-ventricle circulation" Exclusion Criteria: congenital heart diaese with univentricular heart physiology |
Country | Name | City | State |
---|---|---|---|
France | Hopital Europen Georges Pompidou | Paris |
Lead Sponsor | Collaborator |
---|---|
European Georges Pompidou Hospital | Centre Hospitalier Universitaire Vaudois, Erasmus Medical Center, Hospitales Universitarios Virgen del Rocío, KU Leuven, Royal Brompton & Harefield NHS Foundation Trust, University Hospital, Geneva |
France,
Kammeraad JA, van Deurzen CH, Sreeram N, Bink-Boelkens MT, Ottenkamp J, Helbing WA, Lam J, Sobotka-Plojhar MA, Daniels O, Balaji S. Predictors of sudden cardiac death after Mustard or Senning repair for transposition of the great arteries. J Am Coll Cardi — View Citation
Khairy P, Harris L, Landzberg MJ, Fernandes SM, Barlow A, Mercier LA, Viswanathan S, Chetaille P, Gordon E, Dore A, Cecchin F. Sudden death and defibrillators in transposition of the great arteries with intra-atrial baffles: a multicenter study. Circ Arrh — View Citation
Schwerzmann M, Salehian O, Harris L, Siu SC, Williams WG, Webb GD, Colman JM, Redington A, Silversides CK. Ventricular arrhythmias and sudden death in adults after a Mustard operation for transposition of the great arteries. Eur Heart J. 2009 Aug;30(15):1 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | sudden cardiac death, | 2000 to 2018 | ||
Primary | near-miss sudden death | 2000 to 2018 | ||
Primary | sustained VT requiring defibrillation | 2000 to 2018 | ||
Secondary | all causes of death | heart failure, atrial arrhythmia, AV block, stroke | 2000 to 2018 |
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