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

To Evaluate the Safety and Effectiveness Evaluation of Using Echocardiography-guided Liwen RF Radiofrequency Ablation System to Treat Hypertrophic Obstructive Cardiomyopathy

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.

Study Overview

• Status: Unknown
• Conditions: Hypertrophic Obstructive Cardiomyopathy
• Intervention / Treatment: Procedure: Echocardiography-guided Radiofrequency ablation for Hypertrophic obstructive Cardiomyopathy (HOCM).

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Ultrasound Medicine Department of Xijing Hospital, Fourth Military Medical University
      • Contact: LiWen Liu, MD; Phone Number: 86-13571975528

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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%).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Main adverse event	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.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Instrument success	Radiofrequency ablation system instruments reach the desired treatment site and successfully complete ablation,and remove the system successfully.	30 days
Operation success	Improvement of LVOTG > 50% within 90 days after operation	90 days
No main adverse events related to instruments or surgery within 90 days of instrument use		90 days
Life quality score of SF-36	The life quality score of SF-36 was significantly improved after the operation.	90 days

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Collaborators: Hangzhou Nuo Cheng Medical Instrument Co.,Ltd

Publications and helpful links

General Publications

• Han C, Zhou M, Hu R, Wang B, Zuo L, Li J, Ta S, Hsi DH, Liu J, Wei L, Liu L. Trans-Septal Myocardial Biopsy in Hypertrophic Cardiomyopathy Using the Liwen Procedure: An Introduction of a Novel Technique. J Interv Cardiol. 2021 Feb 10;2021:1905184. doi: 10.1155/2021/1905184. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 30, 2019
• Primary Completion (ANTICIPATED): June 30, 2021
• Study Completion (ANTICIPATED): July 31, 2021

Study Registration Dates

• First Submitted: April 17, 2020
• First Submitted That Met QC Criteria: April 17, 2020
• First Posted (ACTUAL): April 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 15, 2021
• Last Update Submitted That Met QC Criteria: January 12, 2021
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Cardiomyopathy, hypertrophic;techniques; Treatment outcome
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Hypertrophy; Cardiomyopathies; Cardiomyopathy, Hypertrophic
• Other Study ID Numbers: KY20192076-F-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No