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Echocardiography-guided Transthoracic Radio Frequency/Laser Ablation for Ventricular Septum of Hypertrophic Obstructive Cardiomyopathy

Primary Purpose

Hypertrophic Obstructive Cardiomyopathy

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Echocardiography-guided transthoracic radio frequency ablation for HOCM ventricular septum
Echocardiography-guided transthoracic laser ablation for HOCM ventricular septum
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertrophic Obstructive Cardiomyopathy

Eligibility Criteria

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

Inclusion Criteria:

  • Subject who cannot tolerate ventricular septum resection or transcatheter ethanol ablation and volunteer for the operation
  • Subject meets HOCM diagnosis standards verified by the echocardiogram; the obstruction is located in the basal part of ventricular septum
  • Subject has significant clinical symptoms, including progressively increasing fatigue, angina, exertional dyspnea, and syncope; subject receives poor effect after drug therapy or cannot tolerate side effects of medication
  • Subject has pressure gradient of left ventricular outflow tract (LVOT) ≥50 mmHg(with Systolic Anterior Motion)in the resting-state or after exercise stress test
  • Subject over 18 years old

Exclusion Criteria:

  • Subject has non-obstructive hypertrophic cardiomyopathy
  • Subject has combined cerebral vascular diseases
  • Subject has diseases that must receive surgeries, including severe mitral valve lesions and coronary heart disease which requires coronary artery bypass grafting.
  • Subject has end-stage heart failure
  • Subject has intraventricular septal thickness (IVST) ≥ 30mm

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hypertrophic Obstructive Cardiomyopathy

Arm Description

Outcomes

Primary Outcome Measures

Mortality
Quantification of obstructive severity
Investigators use pressure gradient of left ventricular outflow tract (LVOT) to quantify obstructive severity. If the pressure gradient increases, the symptom gets deteriorated; if the pressure gradient decreases, the symptom gets relieved.

Secondary Outcome Measures

Quantification of cardiac function
Investigators use ejection function (EF) to quantify the systolic function. If EF is higher after the operation, the systolic function gets improved; if EF lower after the operation, the systolic function gets deteriorate. Investigators use diastolic degree to evaluate the diastolic function. If diastolic degree is lower after the operation, the diastolic function gets improved; If diastolic degree is higher after the operation, the diastolic function gets deteriorated.
Quantification of conduction block
If there is no conduction block observed, the therapy is successful; if there is conduction block, it could be considered as one potential complication.

Full Information

First Posted
August 29, 2016
Last Updated
August 29, 2016
Sponsor
Xijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02888132
Brief Title
Echocardiography-guided Transthoracic Radio Frequency/Laser Ablation for Ventricular Septum of Hypertrophic Obstructive Cardiomyopathy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
Hypertrophic Obstructive Cardiomyopathy (HOCM) patients have significant clinical symptoms, including progressively increasing fatigue, angina, exertional dyspnea, and syncope. Conservative medications are used to treat the vast majority of patients. Invasive therapy, which includes surgical myectomy, septal ethanol ablation and dual-chamber pacing is introduced to patients with refractory symptoms or drug resistance. Considering the sternotomy and relatively high patients' tolerance required in myectomy, the potentially risky misplacement of ethanol and the anatomic variability of the vascularised hypertrophic septum, and the potential risk of conduction block after these two treatments, the development of new minimally invasive approach is warranted. Previous researches have illustrated the effectiveness and feasibility of transcatheter radio frequency ablation for HOCM patients. By far, there has been no report on transthoracic laser-induced interstitial thermotherapy (LITT) for human treatment. Since 2004, our department has adopted High Intensity Focused Ultrasound, radio frequency and laser in solid tumors treatment, including liver tumors and fibroid. Also our center has conducted several animal experiments to verify the feasibility of radio frequency/laser in septal myocardium ablation. The purpose of this study is to lead echocardiography-guided transthoracic radio frequency/laser ablation for HOCM ventricular septum, make minimally invasive treatment plans for HOCM patients, and verify the safety and validity of intervention treatment in long term.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Obstructive Cardiomyopathy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Hypertrophic Obstructive Cardiomyopathy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Echocardiography-guided transthoracic radio frequency ablation for HOCM ventricular septum
Intervention Type
Procedure
Intervention Name(s)
Echocardiography-guided transthoracic laser ablation for HOCM ventricular septum
Primary Outcome Measure Information:
Title
Mortality
Time Frame
24 months
Title
Quantification of obstructive severity
Description
Investigators use pressure gradient of left ventricular outflow tract (LVOT) to quantify obstructive severity. If the pressure gradient increases, the symptom gets deteriorated; if the pressure gradient decreases, the symptom gets relieved.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Quantification of cardiac function
Description
Investigators use ejection function (EF) to quantify the systolic function. If EF is higher after the operation, the systolic function gets improved; if EF lower after the operation, the systolic function gets deteriorate. Investigators use diastolic degree to evaluate the diastolic function. If diastolic degree is lower after the operation, the diastolic function gets improved; If diastolic degree is higher after the operation, the diastolic function gets deteriorated.
Time Frame
24 months
Title
Quantification of conduction block
Description
If there is no conduction block observed, the therapy is successful; if there is conduction block, it could be considered as one potential complication.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject who cannot tolerate ventricular septum resection or transcatheter ethanol ablation and volunteer for the operation Subject meets HOCM diagnosis standards verified by the echocardiogram; the obstruction is located in the basal part of ventricular septum Subject has significant clinical symptoms, including progressively increasing fatigue, angina, exertional dyspnea, and syncope; subject receives poor effect after drug therapy or cannot tolerate side effects of medication Subject has pressure gradient of left ventricular outflow tract (LVOT) ≥50 mmHg(with Systolic Anterior Motion)in the resting-state or after exercise stress test Subject over 18 years old Exclusion Criteria: Subject has non-obstructive hypertrophic cardiomyopathy Subject has combined cerebral vascular diseases Subject has diseases that must receive surgeries, including severe mitral valve lesions and coronary heart disease which requires coronary artery bypass grafting. Subject has end-stage heart failure Subject has intraventricular septal thickness (IVST) ≥ 30mm
Facility Information:
Facility Name
Ultrasound Medicine Department of Xijing Hospital, Fourth Military Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liwen Liu, MD
Phone
86-13571975528
Email
liuliwencrt@hotmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
33680117
Citation
Wang XY, Wang B, Zhu XL, Ma ZL, Liu Y, Lei CH, Yang QL, Hu D, Zhao XL, Liu ZR, Liu LW. Clinical and molecular characterization of seven patients with Danon disease. Exp Ther Med. 2021 Apr;21(4):395. doi: 10.3892/etm.2021.9826. Epub 2021 Feb 24.
Results Reference
derived

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Echocardiography-guided Transthoracic Radio Frequency/Laser Ablation for Ventricular Septum of Hypertrophic Obstructive Cardiomyopathy

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