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

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000031936
Enrollment
Unknown
Registered
2020-04-15
Start date
2020-07-08
Completion date
Unknown
Last updated
2020-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertrophic obstructive Cardiomyopathy

Interventions

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

Sponsors

The First Affiliated Hospital of Air Force Medical
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 100 Years

Inclusion criteria

Inclusion criteria: 1. Subject with quiescent condition or Intracardiac cavity of left ventricle after stimulation or Left Ventricle Outflow Tract Gradient >= 50 mmHg. 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%).

Design outcomes

Primary

MeasureTime frame
Clinical and image index;MAE 30 days after operation;

Countries

China

Contacts

Public ContactLiwen Liu

The First Affiliated Hospital of Air Force Medical

liuliwen@fmmu.edu.cn029-84771671

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026