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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
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital

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.


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)
Primary Purpose: Treatment
Study Start Date : April 2016
Estimated Primary Completion Date : May 2018


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Mortality [ Time Frame: 24 months ]
  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02888132


Locations
China, Shaanxi
Ultrasound Medicine Department of Xijing Hospital, Fourth Military Medical University Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Liwen Liu, MD    86-13571975528    liuliwencrt@hotmail.com   
Sponsors and Collaborators
Xijing Hospital

Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT02888132     History of Changes
Other Study ID Numbers: KY20162042-1
First Posted: September 2, 2016    Key Record Dates
Last Update Posted: September 2, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Cardiomyopathies
Hypertrophy
Cardiomyopathy, Hypertrophic
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases