Hypoplastic Left Heart Syndrome: Subendocardial Viability After Norwood Palliation
- Conditions
- Hypoplastic Left Heart Syndrome
- Registration Number
- NCT05709275
- Lead Sponsor
- IRCCS Policlinico S. Donato
- 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;
2. Creation of a prospective registry that will enroll all patients surgically treated for HLHS at the IRCCS Policlinico San Donato.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 6
- Pediatric patients (age ≤18 years) with the diagnosis of hypoplastic left heart syndrome who underwent the Norwood palliation at the IRCCS Policlinico San Donato.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mortality during the hospital stay and after the discharge 5 year death, cardiovascular arrest
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
IRCCS Policlinico San Donato
🇮🇹San Donato, Milano, Italy