CompletedNot Applicable

Systemic Right Ventricle Long-term Outcome

Belgium, Netherlands542 participantsStarted 2022-08-26

Plain-language summary

Patients with the transposition of great arteries (TGA) who undergo atrial switch operation and congenitally corrected TGA (ccTGA) patients have the right ventricle as their systemic ventricle. Function of the systemic right ventricle (SRV) could deteriorate which is associated with impaired prognosis. It is of paramount importance to understand the course and fate of these patients during a long-term follow-up to identify the determinants of adverse outcomes.

Who can participate

Age range12 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients aged 12 years old and older * Surgically corrected transposition of the great arteries (TGA) patients with a systemic right ventricle (SRV) (Mustard, Senning) * Congenitally corrected TGA patients with a systemic right ventricle Exclusion Criteria: \* None.

What they're measuring

All-cause mortality

Timeframe: Through study completion, an average of 18 years

Incident heart failure

Timeframe: Through study completion, an average of 18 years

Number of patients with heart failure hospitalization

Timeframe: Through study completion, an average of 18 years

Number of patients with arrhythmias

Timeframe: Through study completion, an average of 18 years

Number of patients with thromboembolic events

Timeframe: Through study completion, an average of 18 years

Infective endocarditis

Timeframe: Through study completion, an average of 18 years

Number of patients with tricuspid valve surgery

Timeframe: Through study completion, an average of 18 years

Number of patients with ventricular Assist Device implantation

Timeframe: Through study completion, an average of 18 years

Trial details

NCT IDNCT06258083

SponsorUniversity Medical Center Groningen

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-08-24

View on ClinicalTrials.gov More Transposition of the Great Arteries trials

Plain-language summary

Who can participate

Age range12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

All-cause mortality

Timeframe: Through study completion, an average of 18 years

Incident heart failure

Timeframe: Through study completion, an average of 18 years

Number of patients with heart failure hospitalization

Timeframe: Through study completion, an average of 18 years

Number of patients with arrhythmias

Timeframe: Through study completion, an average of 18 years

Number of patients with thromboembolic events

Timeframe: Through study completion, an average of 18 years

Infective endocarditis

Timeframe: Through study completion, an average of 18 years

Number of patients with tricuspid valve surgery

Timeframe: Through study completion, an average of 18 years

Number of patients with ventricular Assist Device implantation

Timeframe: Through study completion, an average of 18 years