Status:
UNKNOWN
The Clinical Research of the Safety and Effectiveness Evaluation for Using Echocardiography-guided Liwen RF Radiofrequency Ablation System to Treat Hypertrophic Obstructive Cardiomyopathy
Lead Sponsor:
Xijing Hospital
Collaborating Sponsors:
Hangzhou Nuo Cheng Medical Instrument Co.,Ltd
Conditions:
Hypertrophic Obstructive Cardiomyopathy
Eligibility:
All Genders
Phase:
NA
Brief Summary
Objective to investigate the safety and effectiveness of Echocardiography-guided radiofrequency ablation in patients with Hypertrophic obstructive Cardiomyopathy (HOCM). Percutaneous intramyocardial ...
Eligibility Criteria
Inclusion
- 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 with obvious clinical symptoms.
- Subject with New York Heart Association (NYHA) cardiac function ≥ II grade.
- Subject with adequate drug treatment is not effective or cannot tolerate side effects of the drug.
- 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
- Subject is pregnant, lactating, or planned to conceive during a clinical study.
- Subject with Hypertrophic Non-obstructive Cardiomyopathy.
- Subject with interventricular septal thickness ≥ 30mm.
- Subject with Sudden Cardiac Death Index ≥ 10%.
- Subject combined with other heart diseases requires surgical treatment.
- Subject with heart failure(Defined as resting heart failure after intensive anti-heart failure therapy, left ventricular fraction of ejecting\< 40%).
Key Trial Info
Start Date :
July 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2021
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04355260
Start Date
July 30 2019
End Date
July 31 2021
Last Update
January 15 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ultrasound Medicine Department of Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, China, 710032