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Bipolar percutaneous endocardial septal radiofrequency ablation (Bi-PESA) treatment: A multicenter, prospective clinical study on hypertrophic obstructive cardiomyopathy

Bipolar percutaneous endocardial septal radiofrequency ablation (Bi-PESA) treatment: A multicenter, prospective clinical study on hypertrophic obstructive cardiomyopathy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124896
Enrollment
Unknown
Registered
2026-05-19
Start date
2026-06-10
Completion date
Unknown
Last updated
2026-05-25

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:Bipolar percutaneous Endocardial Septal Radiofrequency Ablation

Sponsors

Chinese Academy of Medical Sciences Fuwai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) Patients aged 18-85 with symptomatic HOCM; (2) Patients who are not suitable for surgical procedures or who subjectively refuse surgical procedures; (3) Patients who do not have suitable coronary vessels for chemical ablation or who subjectively refuse chemical ablation; (4) Resting or provoked left ventricular outflow tract transvalvular pressure gradient =50mmHg; (5) Cardiac ultrasound excludes giant papillary muscles or the presence of abnormal muscle bundles; (6) Patients who agree to be enrolled and can complete follow-up on time.

Exclusion criteria

Exclusion criteria: (1) Patients with abnormal muscle bundles (false tendons, hypertrophic papillary muscles, etc.) indicated by transthoracic echocardiography; (2) Patients with isolated hypertrophic cardiomyopathy (HOCM); (3) Patients with HOCM accompanied by ventricular dilation or heart failure; (4) Patients with concomitant malignancy or life expectancy less than 1 year; (5) Patients who are not suitable for surgery during the acute phase of the disease.

Design outcomes

Primary

MeasureTime frame
The decrease proportion of LVOTG after 3 months of surgery compared to before proceduree;

Secondary

MeasureTime frame
Improvement in NYHA functional classification;Syncope/pre-syncope relief rate;Interventricular septal thickness;Proportion of patients transferred to surgical department for septal resection;Permanent pacemaker implantation rate;Bundle branch block;Cardiac tamponade;Complications of vascular puncture;All cause mortality;

Countries

China

Contacts

Public ContactJia Yuhe

Chinese Academy of Medical Sciences Fuwai Hospital

jiayuhejyh@163.com+86 137 0135 8427

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 30, 2026