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Clinical Trials/NCT04777188
NCT04777188
Completed
Not Applicable

Left Ventricular Systolic Function After Percutaneous Intramyocardial Septal Radiofrequency Ablation for Hypertrophic Obstructive Cardiomyopathy: a Study Focused on Speckle Tracking Echocardiography

Xijing Hospital1 site in 1 country70 target enrollmentOctober 22, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertrophic Obstructive Cardiomyopathy
Sponsor
Xijing Hospital
Enrollment
70
Locations
1
Primary Endpoint
Left ventricular systolic function before and after Percutaneous Intramyocardial Septal Radiofrequency Ablation
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 22, 2016
End Date
July 9, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Xijing Hospital
Responsible Party
Principal Investigator
Principal Investigator

Liu Liwen

Director

Xijing Hospital

Eligibility Criteria

Inclusion Criteria

  • 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
  • Patients with a peak LVOT gradient≥50 mm Hg

Exclusion Criteria

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

Outcomes

Primary Outcomes

Left ventricular systolic function before and after Percutaneous Intramyocardial Septal Radiofrequency Ablation

Time Frame: 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 Outcomes

  • left ventricular outflow tract gradient before and after Percutaneous Intramyocardial Septal Radiofrequency Ablation(1 year)
  • Interventricular septal thickness before and after Percutaneous Intramyocardial Septal Radiofrequency Ablation(1 year)

Study Sites (1)

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