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Hypoplastic Left Heart Syndrome: Subendocardial Viability After Norwood Palliation

Hypoplastic Left Heart Syndrome: Subendocardial Viability After Norwood Palliation

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05709275
Acronym
HLHS
Enrollment
6
Registered
2023-02-02
Start date
2022-07-28
Completion date
2024-09-30
Last updated
2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoplastic Left Heart Syndrome

Brief 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.

Interventions

None listed

Sponsors

IRCCS Policlinico S. Donato
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Mortality during the hospital stay and after the discharge5 yeardeath, cardiovascular arrest

Secondary

MeasureTime frameDescription
Number of adverse events registered during the follow-up.5 yearPatients will be followed prospectively with their normal routine cardiological follow-up for 5 years

Other

MeasureTime frameDescription
Number of adverse events at the three-staged palliation (short and long-term mortality)5 yearPatients will be followed prospectively with their normal routine cardiological follow-up aiming to capture adverse events and clinical status.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026