The Fate of Aortic Valve After SAS Surgery in Children | NCT06751368

Studies
The Fate of Aortic Valve After SAS Surgery in Children

NCT06751368

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Status

Completed

Last Update Posted

Dec 27, 2024Actual

Enrollment

232Actual

Phase

Not provided

Conditions

Subaortic Stenosis
Congenital Heart Disease
Aortic Regurgitation

Interventions

Not provided

Countries

China

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

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2008Actual

Primary Completion Date

Nov 30, 2024Actual

Completion Date

Nov 30, 2024Actual

First Submitted Date

Dec 19, 2024

First Submission Date that Met QC Criteria

Dec 24, 2024

First Posted Date

Dec 27, 2024Actual

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

Dec 24, 2024

Last Update Posted Date

Dec 27, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Pan Xiangbin, Principal Investigator, Chinese Academy of Medical Sciences, Fuwai HospitalPrincipal Investigator

Lead Sponsor

Chinese Academy of Medical Sciences, Fuwai HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Aortic valve regurgitation (AR) is a common complication following surgery for subaortic stenosis (SAS), yet the long-term outcomes and risk factors for postoperative significant AR (SAR) remain poorly understood. This study aims to investigate the incidence and risk factors of SAR in SAS patients and evaluate the long-term postoperative outcomes.

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

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

232Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of Postoperative significant AR (SAR)		Through study completion, an average of 4 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age from 0-18
Clinical diagnosis of subaortic stenosis and underwent surgery

Exclusion Criteria:

Diagnosed with hypertrophic cardiomyopathy
Underwent concomitant previous surgical repair for aortic valve or SAS
Follow-up time less than 1 year or lack of detailed information.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Patients age from 0-18 underwent SAS surgical repair at Fuwai Hospital.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fuwai Hospital		Beijing	Beijing Municipality	100069	China

Condition Browse Module

MeSH Terms

ID	Term
D001020	Aortic Stenosis, Subvalvular
D006330	Heart Defects, Congenital
D001022	Aortic Valve Insufficiency

Ancestor Terms

ID	Term
D001024	Aortic Valve Stenosis
D000082862	Aortic Valve Disease
D006349	Heart Valve Diseases
D006331	Heart Diseases

Browse Leaves

Not provided

Browse Branches

Not provided