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

Primary Purpose

Hypertrophic Obstructive Cardiomyopathy

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Percutaneous Intramyocardial Septal Radiofrequency Ablation for hypertrophic obstructive cardiomyopathy
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertrophic Obstructive Cardiomyopathy focused on measuring Cardiomyopathy, hypertrophic, Speckle tracking echocardiography

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ultrasound Medicine Department of Xijing Hospital, Fourth Military Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hypertrophic Obstructive Cardiomyopathy

Arm Description

Left ventricular systolic function by speckle tracking echocardiography before and after percutaneous intramyocardial septal radiofrequency ablation for hypertrophic obstructive cardiomyopathy.

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
February 3, 2021
Last Updated
March 3, 2021
Sponsor
Xijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04777188
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 22, 2016 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
July 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Obstructive Cardiomyopathy
Keywords
Cardiomyopathy, hypertrophic, Speckle tracking echocardiography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hypertrophic Obstructive Cardiomyopathy
Arm Type
Experimental
Arm Description
Left ventricular systolic function by speckle tracking echocardiography before and after percutaneous intramyocardial septal radiofrequency ablation for hypertrophic obstructive cardiomyopathy.
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Intramyocardial Septal Radiofrequency Ablation for hypertrophic obstructive cardiomyopathy
Intervention Description
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 for up to 12 min and the ablation power is gradually increased 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).
Primary Outcome Measure Information:
Title
Left ventricular systolic function before and after Percutaneous Intramyocardial Septal Radiofrequency Ablation
Description
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)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
left ventricular outflow tract gradient before and after Percutaneous Intramyocardial Septal Radiofrequency Ablation
Description
The results were obtained by continuous Doppler echocardiography (mmHg)
Time Frame
1 year
Title
Interventricular septal thickness before and after Percutaneous Intramyocardial Septal Radiofrequency Ablation
Description
The results were obtained by echocardiography , the unit of mm
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Ultrasound Medicine Department of Xijing Hospital, Fourth Military Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710000
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
36270787
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.
Results Reference
derived

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

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