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HLHS: Hypoplastic Left Heart Syndrome: Subendocardial Viability After Norwood Palliation

Sponsor
IRCCS Policlinico S. Donato (Other)
Overall Status
Recruiting
CT.gov ID
NCT05709275
Collaborator
(none)
60
Enrollment
1
Location
60
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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;

  1. Creation of a prospective registry that will enroll all patients surgically treated for HLHS at the IRCCS Policlinico San Donato.
Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Hypoplastic Left Heart Syndrome: Subendocardial Viability After Norwood Palliation
    Actual Study Start Date :
    Jul 28, 2022
    Anticipated Primary Completion Date :
    Jul 28, 2027
    Anticipated Study Completion Date :
    Jul 28, 2027

    Outcome Measures

    Primary Outcome Measures

    1. Mortality during the hospital stay and after the discharge [5 year]

      death, cardiovascular arrest

    Secondary Outcome Measures

    1. Number of adverse events registered during the follow-up. [5 year]

      Patients will be followed prospectively with their normal routine cardiological follow-up for 5 years

    Other Outcome Measures

    1. Number of adverse events at the three-staged palliation (short and long-term mortality) [5 year]

      Patients will be followed prospectively with their normal routine cardiological follow-up aiming to capture adverse events and clinical status.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 IRCCS Policlinico San Donato San Donato Milano Italy 20134

    Sponsors and Collaborators

    • IRCCS Policlinico S. Donato

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Antonio Saracino, Principal Investigator, IRCCS Policlinico S. Donato
    ClinicalTrials.gov Identifier:
    NCT05709275
    Other Study ID Numbers:
    • HLHS
    First Posted:
    Feb 2, 2023
    Last Update Posted:
    Feb 2, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hypoplastic Left Heart Syndrome
    Syndrome

    Study Results

    No Results Posted as of Feb 2, 2023