Speckle Tracking Echocardiography Analysis of Left Ventricular Myocardium After Percutaneous Intramyocardial Septal Radiofrequency Ablation for Hypertrophic Obstructive Cardiomyopathy

Not Applicable

Completed

• Conditions: Hypertrophic Obstructive Cardiomyopathy

• Registration Number: NCT04777188
• Lead Sponsor: Xijing Hospital

Brief Summary

Objective to investigate the left ventricular (LV) systolic function by speckle tracking echocardiography before and after percutaneous intramyocardial septal radiofrequency ablation for hypertrophic obstructive cardiomyopathy (HOCM).

Percutaneous intramyocardial septal radiofrequency ablation (named Liwen Procedure) is a safe and effective treatment approach for HOCM and results in sustained improvement in exercise capacity and persistent in reducing left ventricle outflow tract (LVOT) gradient. However, the systolic function of the myocardial after Liwen procedure in HOCM patients is not well exploration and research. Strain evaluation using speckle tracking echocardiography is an excellent tool for assessing regional and global LV functions.

In this study, the investigators aimed to characterize regional and global strain using speckle tracking echocardiography to assess LV radial, circumferential and longitudinal systolic myocardial function in patients with HOCM before and after Liwen procedure.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-22
• Primary Completion: 2019-07-01
• Study Completion: 2019-07-09
• Study First Submitted: 2021-02-03
• Study First Submitted QC: 2021-02-25
• Status Verified: 2021-03
• Study First Posted: 2021-03-02
• Last Update Submitted: 2021-03-03
• Last Update Posted: 2021-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Patients 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. Patients with a peak LVOT gradient≥50 mm Hg

Exclusion Criteria

1. Those with a peak instantaneous Doppler LVOT gradient of <50 mm Hg
2. Those with an indication for septal reduction therapy and other lesions requiring surgical intervention (e.g., mitral valve repair/replacement and papillary muscle intervention)
3. Those with end-stage heart failure；and those the echocardialology image quality is not clear enough for strain analysis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Left ventricular systolic function before and after Percutaneous Intramyocardial Septal Radiofrequency Ablation	1 year	The left ventricular(LV) systolic function was analyzed by Tomtec Workstation with related software. LV was automatically divided into 16 segments using standard segmentation. The following LV parameters were automatically calculated by the software. The 3D strain indexes derived included ,LV peak systolic global longitudinal strain (GLS,percent), LV peak systolic global radial strain (GRS,percent), LV peak systolic global circumferential strain (GCS,percent)

Secondary Outcome Measures

Name	Time	Method
left ventricular outflow tract gradient before and after Percutaneous Intramyocardial Septal Radiofrequency Ablation	1 year	The results were obtained by continuous Doppler echocardiography (mmHg)
Interventricular septal thickness before and after Percutaneous Intramyocardial Septal Radiofrequency Ablation	1 year	The results were obtained by echocardiography , the unit of mm

Trial Locations

Locations (1)

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