unroofing or other surgery if needed
Procedureunroofing of coronary artery
Other names: clinical follow up
NCT Number: NCT06089902
Anomalous aortic origin of a coronary artery (AAOCA) is a group of rare congenital heart defects with various clinical presentations. The lifetime-risk of an individual living with AAOCA is unknown, and data from multicentre registries are urgently needed to adapt current recommendations and guide optimal patient management. The European Registry for AAOCA (EURO-AAOCA) aims to assess differences with regard to AAOCA management between centres.
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Observational
Massimo Padalino, Padova, PD, Italy
EURO AAOCA study database on management for "ANOMALOUS AORTIC ORIGIN OF CORONARY ARTERIES.
This is a simple Excel database in 8 sections (see below). The patient's identification (ID) should be anonymous, and can be decided by each center; the investigators suggest to enclose Centre ID number (which is communicated by the leading center) and a sequential number or date of birth (dd/mm/yy).
If no procedure has been done for the patients , it is required to the "PERIPROCEDURAL, SURGICAL DETAILS" and "POSTPROCEDURAL" data sheets (which are outlined in RED). In the "PERIPROCEDURAL" sheet, the participants may refer either to the surgical or non surgical procedure.
Baseline and long term clinical evaluation sections must be completed for all patients.
In the database, there are lists of multiple different variables which are summarized in tables enclosed in the section, in which each item corresponds to a number.
EURO AAOCA Study DATABASE sections
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
unroofing of coronary artery
Other names: clinical follow up
Time frame: 5 years
The study will assess the presence of symptoms (angina, chest pain, distress, sudden cardiac death-SCD, syncope, aborted SCD) at diagnosis, and after eventual surgical repair, to assess incidence of symptoms in patients with this anomaly and effectiveness of surgery in removing symptoms.
Time frame: 5 years
The study will assess the incidence of operative death and adverse events after surgery (in those who undergo surgery).
Time frame: 5 years
The study will assess the incidence of death and adverse events at clinical follow up either in patients who required a surgical repair or in those who did not undergo surgery because of lack of indications.
Time frame: 5 years
The study will assess the incidence of any (mostly ventricular) arrhythmias in all patients, either surgical or non surgical
Time frame: 5 years
The study will assess the rate of return to unrestricted sport and competitive sport activity in all patients, either surgical or non surgical
Contact information is provided by the study sponsor or research team.
Chris Grani, MD PhD
CONTACT
Massimo Padalino, MD PhD
CONTACT
University of Padova
Other
EUROAAOCA Registry
Acronym: EUROAAOCA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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