NCT06598995

Brief Summary

This study investigated the impact of myocardial bridging (MB) and its characteristics on preoperative atrial fibrillation and survival in patients with obstructive hypertrophic cardiomyopathy (oHCM). We recruited 968 consecutive patients with oHCM who underwent myectomy at our institution between January 2015 and December 2019, including 144 patients with MB and 824 patients without MB. All patients received angiography before surgery. The diagnosis of preoperative atrial fibrillation was based on 12-lead electrocardiography, 24-hour Holter electrocardiography, or in-hospital electrocardiogram monitoring, which was extracted from patients' medical records. Surgical details and follow-up data were also collected.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
968

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

12 months

First QC Date

September 12, 2024

Last Update Submit

September 12, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • All-cause death

    Any death occurred one month after discharge

    One month after discharge

Secondary Outcomes (2)

  • New-onset AF

    One month after discharge.

  • Composite endpoints

    One month after discharge

Study Arms (1)

Obstructive hypertrophic cardiomyopathy who underwent septal myectomy

All patients underwent angiography and without other coronary artery disease.

Procedure: Coronary artery bypass grafting or unroofing

Interventions

Patients had an MB with \>75% compression degree would receive coronary artery bypass grafting, and those who underwent unroofing may had a depth of MB \< 5mm (whether deal with these MB with a depth \<5mm depends on the surgeon and the period time of patients received a surgery).

Obstructive hypertrophic cardiomyopathy who underwent septal myectomy

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients diagnosed with obstructive hypertrophic cardiomyopathy who underwent septal myectomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai Hospital

Beijing, Please Select, 475, China

Location

MeSH Terms

Conditions

Myocardial BridgingCardiomyopathy, HypertrophicAtrial Fibrillation

Interventions

Coronary Artery Bypass

Condition Hierarchy (Ancestors)

Coronary Vessel AnomaliesHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCardiomyopathiesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve DiseasesArrhythmias, CardiacPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Myocardial RevascularizationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeVascular GraftingVascular Surgical ProceduresThoracic Surgical Procedures

Study Design

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

Study Record Dates

First Submitted

September 12, 2024

First Posted

September 19, 2024

Study Start

January 1, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations