Echocardiography-guided Transthoracic Radio Frequency/Laser Ablation for Ventricular Septum of Hypertrophic Obstructive Cardiomyopathy
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|ClinicalTrials.gov Identifier: NCT02888132|
Recruitment Status : Unknown
Verified August 2016 by Xijing Hospital.
Recruitment status was: Recruiting
First Posted : September 2, 2016
Last Update Posted : September 2, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Hypertrophic Obstructive Cardiomyopathy||Procedure: Echocardiography-guided transthoracic radio frequency ablation for HOCM ventricular septum Procedure: Echocardiography-guided transthoracic laser ablation for HOCM ventricular septum||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||May 2018|
|Experimental: Hypertrophic Obstructive Cardiomyopathy||
Procedure: Echocardiography-guided transthoracic radio frequency ablation for HOCM ventricular septum
Procedure: Echocardiography-guided transthoracic laser ablation for HOCM ventricular septum
- Mortality [ Time Frame: 24 months ]
- Quantification of obstructive severity [ Time Frame: 24 months ]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.
- Quantification of cardiac function [ Time Frame: 24 months ]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 [ Time Frame: 24 months ]If there is no conduction block observed, the therapy is successful; if there is conduction block, it could be considered as one potential complication.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02888132
|Ultrasound Medicine Department of Xijing Hospital, Fourth Military Medical University||Recruiting|
|Xi'an, Shaanxi, China, 710032|
|Contact: Liwen Liu, MD 86-13571975528 firstname.lastname@example.org|