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Status unknownNCT04355260Updated Jan 15, 2021

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

An interventional study of Echocardiography-guided Radiofrequency ablation for Hypertrophic obstructive Cardiomyopathy (HOCM). in Hypertrophic Obstructive Cardiomyopathy, sponsored by Xijing Hospital. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2021-01-15.

Sponsored by Xijing Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2020), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jul 2019, registered Apr 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Sex
All
01

Study 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.

02

Conditions studied

  • Hypertrophic Obstructive Cardiomyopathy

Keywords

  • Cardiomyopathy, hypertrophic;techniques; Treatment outcome
03

In context

Cardiomyopathies

1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.

This study's planned enrollment of 150 is above the median of 51 across 609 interventional studies indexed under Cardiomyopathies.

Browse Cardiomyopathies studies →

Lead sponsor

Xijing Hospital is the lead sponsor of 465 studies on the registry; 157 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

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%).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Hypertrophic Obstructive Cardiomyopathy

    Procedure: Echocardiography-guided Radiofrequency ablation for Hypertrophic obstructive Cardiomyopathy (HOCM).

Interventions

  • ProcedureEchocardiography-guided Radiofrequency ablation for Hypertrophic obstructive Cardiomyopathy (HOCM).

    Echocardiography-guided Radiofrequency ablation for Hypertrophic obstructive Cardiomyopathy (HOCM).

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 30 days

Secondary outcomes

  1. Instrument success

    Radiofrequency ablation system instruments reach the desired treatment site and successfully complete ablation,and remove the system successfully.

    Time frame: 30 days

  2. Operation success

    Improvement of LVOTG \> 50% within 90 days after operation

    Time frame: 90 days

  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

    The life quality score of SF-36 was significantly improved after the operation.

    Time frame: 90 days

07

Study locations

1 of 1 sites recruiting
  • Ultrasound Medicine Department of Xijing Hospital, Fourth Military Medical University
    Xi'an, Shaanxi 710032, China
    • LiWen Liu, MD · Contact · 86-13571975528
    Recruiting
08

References and documents

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. PubMed 33628143 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04355260
Lead sponsor
Xijing Hospital
Collaborators
Hangzhou Nuo Cheng Medical Instrument Co.,Ltd
Responsible party
Liu Liwen (MD.PHD., Xijing Hospital) — Principal investigator
First posted
Apr 21, 2020
Start date
Jul 30, 2019
Primary completion
Jun 30, 2021 (estimated)
Completion
Jul 31, 2021 (estimated)
Last update
Jan 15, 2021

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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