Echocardiography-guided Transthoracic Radio Frequency/Laser Ablation for Ventricular Septum of Hypertrophic Obstructive Cardiomyopathy
NCT ID: NCT02888132
Last Updated: 2016-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
10 participants
INTERVENTIONAL
2016-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Hypertrophic Obstructive Cardiomyopathy
Echocardiography-guided transthoracic radio frequency ablation for HOCM ventricular septum
Echocardiography-guided transthoracic laser ablation for HOCM ventricular septum
Interventions
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Echocardiography-guided transthoracic radio frequency ablation for HOCM ventricular septum
Echocardiography-guided transthoracic laser ablation for HOCM ventricular septum
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Xijing Hospital
OTHER
Responsible Party
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Locations
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Ultrasound Medicine Department of Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, China
Countries
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Facility Contacts
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References
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Ta S, Li J, Hsi DH, Hu R, Lei C, Shan B, Li W, Wang J, Wang B, Kang N, Li X, Liu J, Qi C, Huang J, Han Y, Ruan F, Zhang J, Liu L. Percutaneous intramyocardial septal radiofrequency ablation after 5-year follow-up. Heart. 2024 May 10;110(11):792-799. doi: 10.1136/heartjnl-2023-323606.
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.
Other Identifiers
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KY20162042-1
Identifier Type: -
Identifier Source: org_study_id
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