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The Clinical Research of the Safety and Effectiveness Evaluation for Using Echocardiography-guided Liwen RF Radiofrequency Ablation System to Treat Hypertrophic Obstructive Cardiomyopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04355260
Recruitment Status : Unknown
Verified July 2020 by Liu Liwen, Xijing Hospital.
Recruitment status was:  Recruiting
First Posted : April 21, 2020
Last Update Posted : January 15, 2021
Sponsor:
Collaborator:
Hangzhou Nuo Cheng Medical Instrument Co.,Ltd
Information provided by (Responsible Party):
Liu Liwen, Xijing Hospital

Study Description
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Brief Summary:

Objective to investigate the safety and effectiveness of Echocardiography-guided radiofrequency ablation in patients with Hypertrophic obstructive Cardiomyopathy (HOCM).

Percutaneous intramyocardial septal radiofrequency ablation (Liwen Procedure) is a safe and effective treatment approach for Hypertrophic obstructive Cardiomyopathy and results in sustained improvement in exercise capacity, persistent in reducing Left Ventricle Outflow Tract (LVOT) gradient, and sustained improvement in cardiac function.

In patients with disabling symptoms caused by Hypertrophic obstructive Cardiomyopathy (HOCM),Echocardiography-guided radiofrequency ablation could be a less invasive treatment option.

Percutaneous intramyocardial septal radiofrequency ablation (Liwen Procedure) is a new method for the diagnosis or treatment of heart disease by using a special diagnosis and treatment device to the heart target area under the guidance of image technology. The method breaks through the worldwide problem of the minimally invasive diagnosis and treatment of the myocardium on the beating heart, so as to avoid the X-ray radiation and contrast agent damage .

As a new pathway of cardiac disease intervention, Liwen Procedure can be used in congenital heart disease, myocardial biopsies, drug injection, cell implantation and instrument implantation in addition to Hypertrophic Cardiomyopathy and cardiac tumors. It has important clinical value and broad application prospect.

In this study, Liwen RF radiofrequency ablation system was used to treat HOCM , and evaluate its safety and effectiveness , in order to provide a new medical device for Liwen Procedure of HOCM.


Condition or disease Intervention/treatment Phase
Hypertrophic Obstructive Cardiomyopathy Procedure: Echocardiography-guided Radiofrequency ablation for Hypertrophic obstructive Cardiomyopathy (HOCM). Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: To Evaluate the Safety and Effectiveness Evaluation of Using Echocardiography-guided Liwen RF Radiofrequency Ablation System to Treat Hypertrophic Obstructive Cardiomyopathy
Actual Study Start Date : July 30, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

Arms and Interventions
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Arm Intervention/treatment
Experimental: Hypertrophic Obstructive Cardiomyopathy Procedure: Echocardiography-guided Radiofrequency ablation for Hypertrophic obstructive Cardiomyopathy (HOCM).
Echocardiography-guided Radiofrequency ablation for Hypertrophic obstructive Cardiomyopathy (HOCM).


Outcome Measures
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Primary Outcome Measures :
  1. Main adverse event [ Time Frame: 30 days ]
    Any instrument or surgery-related complications, including but not limited to death, emergency surgery, severe pericardial tamponade requiring pericardiocentesis or surgery, bleeding, surgery-related stroke.


Secondary Outcome Measures :
  1. Instrument success [ Time Frame: 30 days ]
    Radiofrequency ablation system instruments reach the desired treatment site and successfully complete ablation,and remove the system successfully.

  2. Operation success [ Time Frame: 90 days ]
    Improvement of LVOTG > 50% within 90 days after operation

  3. No main adverse events related to instruments or surgery within 90 days of instrument use [ Time Frame: 90 days ]
  4. Life quality score of SF-36 [ Time Frame: 90 days ]
    The life quality score of SF-36 was significantly improved after the operation.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Subject with obvious clinical symptoms.
  3. Subject with New York Heart Association (NYHA) cardiac function ≥ II grade.
  4. Subject with adequate drug treatment is not effective or cannot tolerate side effects of the drug.
  5. Subject was informed of the nature of the clinical study and agreed to participate in all the requirements of the clinical study, signed an informed consent form, and agreed to complete the following checks.

Exclusion Criteria:

  1. Subject is pregnant, lactating, or planned to conceive during a clinical study.
  2. Subject with Hypertrophic Non-obstructive Cardiomyopathy.
  3. Subject with interventricular septal thickness ≥ 30mm.
  4. Subject with Sudden Cardiac Death Index ≥ 10%.
  5. Subject combined with other heart diseases requires surgical treatment.
  6. Subject with heart failure(Defined as resting heart failure after intensive anti-heart failure therapy, left ventricular fraction of ejecting< 40%).
Contacts and Locations
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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): NCT04355260


Contacts
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Contact: Liwen Liu, MD 86-13571975528 liuliwencrt@hotmail.com

Locations
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China, Shaanxi
Ultrasound Medicine Department of Xijing Hospital, Fourth Military Medical University Recruiting
Xi'an, Shaanxi, China, 710032
Contact: LiWen Liu, MD    86-13571975528      
Sponsors and Collaborators
Xijing Hospital
Hangzhou Nuo Cheng Medical Instrument Co.,Ltd
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Liu Liwen, MD.PHD., Xijing Hospital
ClinicalTrials.gov Identifier: NCT04355260    
Other Study ID Numbers: KY20192076-F-1
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: January 15, 2021
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Liu Liwen, Xijing Hospital:
Cardiomyopathy, hypertrophic;techniques; Treatment outcome
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Hypertrophic
Hypertrophy
Heart Diseases
Cardiovascular Diseases
 Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases