Hypoplastic Left Heart Syndrome: Subendocardial Viability After Norwood Palliation

Hypoplastic Left Heart Syndrome Clinical Trial

— HLHS  

Official title:

Hypoplastic Left Heart Syndrome: Subendocardial Viability After Norwood Palliation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05709275
• Other study ID #: HLHS
• Status: Recruiting
• Start date: July 28, 2022
• Est. completion date: July 28, 2027

Study information

• Verified date: January 2023
• Source: IRCCS Policlinico S. Donato
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 28, 2027
• Est. primary completion date: July 28, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypoplastic Left Heart Syndrome
• Syndrome

Locations

Country	Name	City	State
Italy	IRCCS Policlinico San Donato	San Donato	Milano

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Donato

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of adverse events at the three-staged palliation (short and long-term mortality)	Patients will be followed prospectively with their normal routine cardiological follow-up aiming to capture adverse events and clinical status.	5 year
Primary	Mortality during the hospital stay and after the discharge	death, cardiovascular arrest	5 year
Secondary	Number of adverse events registered during the follow-up.	Patients will be followed prospectively with their normal routine cardiological follow-up for 5 years	5 year