NCT05709275

Brief Summary

This project has several objectives ranging from clinical data analysis to computational simulations as listed below:

  • Mortality;
  • Occurrence of adverse events;
  • Outcome of the three-staged palliation;
  • Creation of a prospective registry that will enroll all patients surgically treated for HLHS at the IRCCS Policlinico San Donato.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 28, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

October 21, 2024

Status Verified

October 1, 2024

Enrollment Period

2.2 years

First QC Date

January 10, 2023

Last Update Submit

October 17, 2024

Conditions

Hypoplastic Left Heart Syndrome

Outcome Measures

Primary Outcomes (1)

  • Mortality during the hospital stay and after the discharge

    death, cardiovascular arrest

    5 year

Secondary Outcomes (1)

  • Number of adverse events registered during the follow-up.

    5 year

Other Outcomes (1)

  • Number of adverse events at the three-staged palliation (short and long-term mortality)

    5 year

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Pediatric patients (age ≤18 years) with the diagnosis of hypoplastic left heart syndrome who underwent the Norwood palliation at the IRCCS Policlinico San Donato.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Policlinico San Donato

San Donato, Milano, 20134, Italy

Location

MeSH Terms

Conditions

Hypoplastic Left Heart Syndrome

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 10, 2023

First Posted

February 2, 2023

Study Start

July 28, 2022

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

October 21, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)