Hypoplastic Left Heart Syndrome: Subendocardial Viability... | NCT05709275

Studies
Hypoplastic Left Heart Syndrome: Subendocardial Viability After Norwood Palliation

NCT05709275

Sponsor

IRCCS Policlinico S. Donato

Status

Terminated

Last Update Posted

Oct 21, 2024Actual

Enrollment

6Actual

Phase

Not provided

Conditions

Hypoplastic Left Heart Syndrome

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

early suspension of the study

Expanded Access Info

Start Date

Jul 28, 2022Actual

Primary Completion Date

Sep 30, 2024Actual

Completion Date

Sep 30, 2024Actual

First Submitted Date

Jan 10, 2023

First Submission Date that Met QC Criteria

Jan 31, 2023

First Posted Date

Feb 2, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2024

Last Update Posted Date

Oct 21, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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;
Creation of a prospective registry that will enroll all patients surgically treated for HLHS at the IRCCS Policlinico San Donato.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Measure	Description	Time Frame
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

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS Policlinico San Donato		San Donato	Milano	20134	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018636	Hypoplastic Left Heart Syndrome

Ancestor Terms

ID	Term
D006330	Heart Defects, Congenital
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases
D006331	Heart Diseases

Browse Leaves

Not provided

Browse Branches

Not provided