Impact of Liwen Procedure in Obstructive Hypertrophic Cardiomyopathy on Arrhythmias

NCT06031519 | Unknown

• 1 other identifier: KY-20232259-C-1
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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

Conditions

Hypertrophic Cardiomyopathy; Arrhythmia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Ventricular tacharrhythmia composite outcome

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

• Arrhythmia

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

Study Arms (1)

Hypertrophic Obstructive Cardiomyopathy Patients underwent Liwen Procedure

Procedure: Percutaneous Intramyocardial Septal Radiofrequency Ablation for hypertrophic obstructive cardiomyopathy (Liwen Procedure)

Interventions

Percutaneous Intramyocardial Septal Radiofrequency Ablation for hypertrophic obstructive cardiomyopathy (Liwen Procedure) 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 Then, the ablation needle is withdrawn 10 mm to prepare for the next application.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).

Hypertrophic Obstructive Cardiomyopathy Patients underwent Liwen Procedure

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are diagnosed with obstructive HCM and with drug-refractory symptoms underwent Liwen Procedure in Xijing Hospital from 2016 to 2023.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Ultrasound Medicine Department of Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 11, 2023
• Study Start: August 22, 2023
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: September 11, 2023

Record last verified: 2023-09

Locations

CN (1)