Impact of Percutaneous Intramyocardial Septal Radiofrequency Ablation in Obstructive Hypertrophic Cardiomyopathy on Arrhythmias

Xijing Hospital1 site in 1 country350 target enrollmentAugust 22, 2023

ConditionsHypertrophic Cardiomyopathy Arrhythmia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hypertrophic Cardiomyopathy
Sponsor: Xijing Hospital
Enrollment: 350
Locations: 1
Primary Endpoint: All-cause and cardiovascular mortality
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this observational study is to learn about the occurrence of various arrhythmias ( tachyarrhythmia and bradyarrhythmia ) during or after Percutaneous Intramyocardial Septal Radiofrequency Ablation. The main questions it aims to answer are:

To investigate the occurrence of various arrhythmias ( tachyarrhythmia and bradyarrhythmia ) during procedure and its relationship with clinical characteristics and procedural parameters
To analyze the changes of 12-lead electrocardiogram and 24-hour dynamic electrocardiogram before and after Percutaneous Intramyocardial Septal Radiofrequency Ablation and their relationships with clinical characteristics and procedural parameters

Registry

clinicaltrials.gov

Start Date

August 22, 2023

End Date

August 31, 2024

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Xijing Hospital

Responsible Party

Principal Investigator

Liu Liwen

Director

Xijing Hospital

Eligibility Criteria

Inclusion Criteria

•Subject with symptoms that limit daily activities (New York Heart Association functional class \>II, exercise-induced syncope) despite adequate medical treatment or when medical treatment is not tolerated
•Subject with a peak LVOT gradient≥50 mm Hg
•Subject volunteers for the Liwen procedure and received the procedure at the Hypertrophic Cardiomyopathy Center of Xijing Hospital.

Exclusion Criteria

•Subject with a peak instantaneous Doppler LVOT gradient of \<50 mm Hg
•Subject with an indication for septal reduction therapy and other lesions requiring surgical intervention (e.g., mitral valve repair/replacement and papillary muscle intervention)
•Subject has end-stage heart failure

Outcomes

Primary Outcomes

All-cause and cardiovascular mortality

Time Frame: From date of procedure until the date of first occurrence of outcome, assessed up to 1 years

All-cause and cardiovascular mortality (defined as sudden cardiac death, Heart Failure-related death, and heart transplant) were the primary outcomes.

Secondary Outcomes

Arrhythmia(From date of procedure until the date of first occurrence of outcome, assessed up to 1 years)
Ventricular tacharrhythmia composite outcome(From date of procedure until the date of first occurrence of outcome, assessed up to 1 years)