Clinical trial NCT04777188: Speckle Tracking Echocardiography Analysis of Left Ventricular Myocardium After Percutaneous Intramyocardial Septal Radiofrequency Ablation for Hypertrophic Obstructive Cardiomyopathy
Official title: Left Ventricular Systolic Function After Percutaneous Intramyocardial Septal Radiofrequency Ablation for Hypertrophic Obstructive Cardiomyopathy: a Study Focused on Speckle Tracking Echocardiography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertrophic Obstructive Cardiomyopathy
Keywords: Cardiomyopathy, hypertrophic
Speckle tracking echocardiography
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2021-03-02
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Left ventricular systolic function before and after Percutaneous Intramyocardial Septal Radiofrequency Ablation
timeFrame: 1 year
Secondary outcomes:
measure: left ventricular outflow tract gradient before and after Percutaneous Intramyocardial Septal Radiofrequency Ablation
timeFrame: 1 year
measure: Interventricular septal thickness before and after Percutaneous Intramyocardial Septal Radiofrequency Ablation
timeFrame: 1 year
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Ultrasound Medicine Department of Xijing Hospital, Fourth Military Medical University
state: Shaanxi
Study officials:
References:
citation: Li J, Zhang J, Shi Y, Sievert H, Taub CC, Bertog S, Ta S, Changhui L, Senser E, Wang J, Hu R, Huang J, Ruan F, Han Y, Li X, Wang B, Zhao X, Liu J, Hsi DH, Liu L. Myocardial mechanics of percutaneous intramyocardial septal radiofrequency ablation. Heart. 2023 Jan 27;109(4):289-296. doi: 10.1136/heartjnl-2022-321597.