NCT06751368

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
232

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2008

Completed
16.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 27, 2024

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

16.9 years

First QC Date

December 19, 2024

Last Update Submit

December 24, 2024

Conditions

Subaortic StenosisCongenital Heart DiseaseAortic Regurgitation

Outcome Measures

Primary Outcomes (1)

  • Rate of Postoperative significant AR (SAR)

    Through study completion, an average of 4 year

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai Hospital

Beijing, Beijing Municipality, 100069, China

Location

MeSH Terms

Conditions

Aortic Stenosis, SubvalvularHeart Defects, CongenitalAortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Aortic Valve StenosisAortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow ObstructionCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 19, 2024

First Posted

December 27, 2024

Study Start

January 1, 2008

Primary Completion

November 30, 2024

Study Completion

November 30, 2024

Last Updated

December 27, 2024

Record last verified: 2024-12

Locations

CN(1)