Impact of Liwen Procedure in Obstructive Hypertrophic Cardiomyopathy on Arrhythmias

Arrhythmia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06031519
• Other study ID #: KY-20232259-C-1
• Status: Active, not recruiting
• Start date: August 22, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: September 2023
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 350
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmia
• Arrhythmias, Cardiac
• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Cardiomyopathy
• Hypertrophy

Intervention

Procedure:
• Percutaneous Intramyocardial Septal Radiofrequency Ablation for hypertrophic obstructive cardiomyopathy (Liwen Procedure)
Under transthoracic echocardiography (TTE) guidance, the puncture site is positioned at the apex. A guiding line is applied along the septal long axis and the radiofrequency ablation electrode needle(17G, Cool-tip™ RF Ablation System and Switching Controller; Medtronic, Minneapolis, MN, USA) pierced towards the hypertrophic anterior interventricular septum (AIVS) 8-10 mm from the subaortic valve. Each ablation lasts up to 12 min, and the ablation power gradually increases from 30-40W. Then, the ablation needle is withdrawn 10 mm to prepare for the next application. Overall, 3-4 applications are performed in each patient. The ablation creates an area of thermal coagulative myocardial necrosis that appears as a hyperechogenic reflection detected by TTE. If deemed necessary, we repeat the procedure at the posterior interventricular septum (PIVS).

Locations

Country	Name	City	State
China	Ultrasound Medicine Department of Xijing Hospital, Fourth Military Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause and cardiovascular mortality	All-cause and cardiovascular mortality (defined as sudden cardiac death, Heart Failure-related death, and heart transplant) were the primary outcomes.	From date of procedure until the date of first occurrence of outcome, assessed up to 1 years
Secondary	Ventricular tacharrhythmia composite outcome	Unexplained syncope, resuscitated cardiac arrests, or appropriate implantable cardioverter-defibrillator charge.	From date of procedure until the date of first occurrence of outcome, assessed up to 1 years
Secondary	Arrhythmia	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.	From date of procedure until the date of first occurrence of outcome, assessed up to 1 years