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

Hypertrophic Obstructive Cardiomyopathy Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02888132
• Other study ID #: KY20162042-1
• Status: Recruiting
• Phase: N/A
• First received: August 29, 2016
• Last updated: August 29, 2016
• Start date: April 2016

Study information

• Verified date: August 2016
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Obstructive Cardiomyopathy
• Hypertrophy

Intervention

Procedure:
• Echocardiography-guided transthoracic radio frequency ablation for HOCM ventricular septum

• Echocardiography-guided transthoracic laser ablation for HOCM ventricular septum

Locations

Country	Name	City	State
China	Ultrasound Medicine Department of Xijing Hospital, Fourth Military Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		24 months	Yes
Primary	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.	24 months	Yes
Secondary	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.	24 months	Yes
Secondary	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.	24 months	Yes