Hypoplastic Left Heart Syndrome: Subendocardial Viability After Norwood Palliation

NCT ID: NCT05709275

Last Updated: 2024-10-21

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 6 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-28
• Study Completion Date: 2024-09-30

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.

Conditions

Hypoplastic Left Heart Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Policlinico S. Donato

OTHER

Sponsor Role: lead

Responsible Party

Antonio Saracino

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IRCCS Policlinico San Donato

San Donato, Milano, Italy

Countries

Italy

Other Identifiers

HLHS

Identifier Type: -

Identifier Source: org_study_id