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Clinical study of percutaneous endocardial septal radiofrequency ablation in the treatment of obstructive hypertrophic cardiomyopathy under the guidance of intracardiac ultrasound

Clinical study of percutaneous endocardial septal radiofrequency ablation in the treatment of obstructive hypertrophic cardiomyopathy under the guidance of intracardiac ultrasound

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054064
Enrollment
Unknown
Registered
2021-12-08
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-11-07

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

Conditions

Hypertrophic cardiomyopathy

Interventions

Group 1:percutaneous endocardial septal radiofrequency ablation in the treatment of obstructive hypertrophic cardiomyopathy under the guidance of intracardiac ultrasound

Sponsors

Zhongshan Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Obstructive hypertrophic cardiomyopathy (LVOTG >= 50 mmHg on echocardiography, resting or stress state), with or without SAM sign; 2. Aged >= 18 years; 3. Accompanied by clinical symptoms (including fatigue, shortness of breath, exertional angina pectoris, amaurosis, syncope, etc. affecting life), insufficient drug treatment effect or intolerable adverse drug reactions; 4. Informed consent of patients and their families, the principle of voluntary participation, and the process of obtaining informed consent conforms to GCP regulations.

Exclusion criteria

Exclusion criteria: 1. There are surgical contraindications: including abnormal coagulation function, contraindications to anticoagulation, pregnant and lactating women; 2. Left ventricular ejection fraction < 40%; 3. Life expectancy < 12 months; 4. Patients who are allergic to anesthetic drugs and cannot tolerate surgery; 5. Combined with other heart diseases requiring surgical treatment; 6. The patient has poor compliance and cannot complete the test requirements; 7. There are patients who are considered unsuitable to participate in this study by other researchers.

Design outcomes

Primary

MeasureTime frame
left ventricular outflow tract gradient, LVOTG;

Secondary

MeasureTime frame
Adverse events;

Countries

China

Contacts

Public ContactZhu Wenqing

Zhongshan Hospital Affiliated to Fudan University

zhu.wenqing@zs-hospital.sh.cn+86 13701630800

Outcome results

None listed

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