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

January 31, 2023 updated by: Antonio Saracino, IRCCS Policlinico S. Donato

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

all patients with HLHS treated surgically and followed medically at the IRCCS Policlinico San Donato

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality during the hospital stay and after the discharge
Time Frame: 5 year
death, cardiovascular arrest
5 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of adverse events registered during the follow-up.
Time Frame: 5 year
Patients will be followed prospectively with their normal routine cardiological follow-up for 5 years
5 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of adverse events at the three-staged palliation (short and long-term mortality)
Time Frame: 5 year
Patients will be followed prospectively with their normal routine cardiological follow-up aiming to capture adverse events and clinical status.
5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Policlinico S. Donato

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 28, 2022

Primary Completion (ANTICIPATED)

July 28, 2027

Study Completion (ANTICIPATED)

July 28, 2027

Study Registration Dates

First Submitted

January 10, 2023

First Submitted That Met QC Criteria

January 31, 2023

First Posted (ACTUAL)

February 2, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 2, 2023

Last Update Submitted That Met QC Criteria

January 31, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HLHS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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