Impact of Liwen Procedure in Obstructive Hypertrophic Cardiomyopathy on Arrhythmias

Active, not recruiting

• Conditions: Hypertrophic Cardiomyopathy; Arrhythmia
• Interventions: Procedure: Percutaneous Intramyocardial Septal Radiofrequency Ablation for hypertrophic obstructive cardiomyopathy (Liwen Procedure)

• Registration Number: NCT06031519
• Lead Sponsor: Xijing Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-22
• Status Verified: 2023-09
• Study First Submitted: 2023-09-04
• Study First Submitted QC: 2023-09-04
• Last Update Submitted: 2023-09-04
• Study First Posted: 2023-09-11
• Last Update Posted: 2023-09-11
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

1. 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
2. Subject with a peak LVOT gradient≥50 mm Hg
3. Subject volunteers for the Liwen procedure and received the procedure at the Hypertrophic Cardiomyopathy Center of Xijing Hospital.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hypertrophic Obstructive Cardiomyopathy Patients underwent Liwen Procedure	Percutaneous Intramyocardial Septal Radiofrequency Ablation for hypertrophic obstructive cardiomyopathy (Liwen Procedure)	-

Primary Outcome Measures

Name	Time	Method
All-cause and cardiovascular mortality	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 Outcome Measures

Name	Time	Method
Arrhythmia	From date of procedure until the date of first occurrence of outcome, assessed up to 1 years	Complete heart block, new permanent pacemaker implantation, non-sustained ventricular tachycardia, sustained ventricular tachycardia, left bundle branch block, right bundle branch block, premature ventricular contractions burden more than 10% monitored by Holter.
Ventricular tacharrhythmia composite outcome	From date of procedure until the date of first occurrence of outcome, assessed up to 1 years	Unexplained syncope, resuscitated cardiac arrests, or appropriate implantable cardioverter-defibrillator charge.

Trial Locations

Locations (1)

Ultrasound Medicine Department of Xijing Hospital, Fourth Military Medical University; 🇨🇳 Xi'an, Shaanxi, China