TerminatedNot Applicable

Hypoplastic Left Heart Syndrome: Subendocardial Viability After Norwood Palliation

Stopped: early suspension of the study

Italy6 participantsStarted 2022-07-28

Plain-language summary

This project has several objectives ranging from clinical data analysis to computational simulations as listed below: 1. Retrospective review of all patients with HLHS treated surgically and followed medically at the IRCCS Policlinico San Donato aiming to assess the SEVR after each step of Norwood palliation to analyze its influences on: * Mortality; * Occurrence of adverse events; * Outcome of the three-staged palliation; 2. Creation of a prospective registry that will enroll all patients surgically treated for HLHS at the IRCCS Policlinico San Donato.

Who can participate

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.

Inclusion Criteria: * Pediatric patients (age ≤18 years) with the diagnosis of hypoplastic left heart syndrome who underwent the Norwood palliation at the IRCCS Policlinico San Donato. Exclusion Criteria: * Patients with any type of atrioventricular discordance. * Pediatric patients (age ≤18 years) with the diagnosis of hypoplastic left heart syndrome who underwent the Norwood palliation at the IRCCS Policlinico San Donato before March 2019.

What they're measuring

Mortality during the hospital stay and after the discharge

Timeframe: 5 year

Trial details

NCT IDNCT05709275

SponsorIRCCS Policlinico S. Donato

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-09-30

View on ClinicalTrials.gov More Hypoplastic Left Heart Syndrome trials