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A retrospective, multicenter, single-objective clinical study of the safety and efficacy of ultrasound-guided percutaneous intraventricular septal radiofrequency ablation in the treatment of obstructive hypertrophic cardiomyopathy

A retrospective, multicenter, single-objective clinical study of the safety and efficacy of ultrasound-guided percutaneous intraventricular septal radiofrequency ablation in the treatment of obstructive hypertrophic cardiomyopathy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500096857
Enrollment
Unknown
Registered
2025-02-07
Start date
2024-06-01
Completion date
Unknown
Last updated
2025-02-10

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

Conditions

Obstructive hypertrophic cardiomyopathy

Interventions

Observation group:None

Sponsors

Department of Ultrasound, The First Affiliated Hospital of the Air Force Medical University (Xijing Hospital).
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1) Enrollment age>=18 years old; 2) Obstructive hypertrophic cardiomyopathy treated by PIMSRA ablation from June 2016 to May 2024; 3) Able to understand the purpose of the clinical trial, voluntarily participate and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Non-obstructive hypertrophic cardiomyopathy; 2) The investigator judged that the patient's compliance was poor and the patient could not complete the study as required, resulting in incomplete clinical data.

Design outcomes

Primary

MeasureTime frame
Left ventricular outflow tract pressure gradient (LVOT gradient) decreased by >=50% or resting left ventricular outflow tract gradient (LVOT gradient) <30 mmHg) ;Death was witnessed within 30 days of surgery;Symptomatic onset and 1 hour death within 30 days after surgery;Symptoms did not worsen within 30 days after surgery, and died at night;Sudden cardiac death (SCD) within 30 days after surgery was saved; The ICD was appropriately discharged within 30 days after surgery;

Secondary

MeasureTime frame
Ventricular septal thickness ;New York Heart Association Functional Classification, NYHA Grade;The left ventricular outflow tract pressure gradient (LVOT pressure gradient) decreased by >=50% or the resting left ventricular outflow tract pressure gradient (LVOT pressure gradient) decreased by <30 mmHg.;Malignant arrhythmias occurred during surgery and within 30 days after surgery;Intraoperative and 30 days postoperatively require drainage and/or surgical cardiac tamponade;Ventricular septal hematoma/ventricular septal perforation requiring emergency surgery intraoperatively and 30 days postoperatively;Cardiogenic shock during and 30 days after surgery;Postoperative thromboembolic events;

Countries

China

Contacts

Public ContactLiwen Liu

The First Affiliated Hospital of Air Force Military Medical University (Xijing Hospital)

liuliwen@fmmu.edu.cn+86 135 7197 2228

Outcome results

None listed

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