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Clinical study on safety and efficacy evaluation of percutaneous endocardial ventricular septal radiofrequency ablation in the treatment of obstructive hypertrophic cardiomyopathy guided by three-dimensional intracardiac echocardiography

Clinical study on safety and efficacy evaluation of percutaneous endocardial ventricular septal radiofrequency ablation in the treatment of obstructive hypertrophic cardiomyopathy guided by three-dimensional intracardiac echocardiography

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035785
Enrollment
Unknown
Registered
2020-08-16
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-08-17

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 ventricular septal radiofrequency ablation in the treatment of obstructive hypertrophic cardiomyopathy guided by three-dimensional intracardiac echocardiography

Sponsors

Zhongshan Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Obstructive hypertrophic cardiomyopathy (echocardiography indicated LVOTG>=50mmHg, resting or loading state), with or without SAM sign; (2) Aged >=18 years old; (3) With or without clinical symptoms (including fatigue, shortness of breath, exertional angina, syncope, etc.), poor efficacy of adequate drug therapy or intolerance to adverse drug reactions; (4) The informed consent and voluntary participation of patients and their families are in accordance with GCP regulations.

Exclusion criteria

Exclusion criteria: (1) Simple apical hypertrophic cardiomyopathy; (2) Non-obstructive hypertrophic cardiomyopathy; (3) LVOTG<50 mmHg (rest or load); (4) Surgical contraindications: including abnormal coagulation function, contraindications for anticoagulation, pregnant and lactating women; (5) Left ventricular ejection fraction < 40%; (6) Life expectancy < 12 months; (7) Patients who are allergic to anesthetic drugs and cannot tolerate surgery; (8) Complications of other heart diseases and require surgical treatment; (9) Poor patient compliance, unable to complete the test requirements; (10) Patients who were considered unfit to participate in this study by other researchers.

Design outcomes

Primary

MeasureTime frame
eft ventricular outflow tract gradient,LVOTG;Adverse events;

Countries

China

Contacts

Public ContactWenqing Zhu

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