Clinical Outcomes of PIMSRA Treating for Hypertrophic Obstructive Cardiomyopathy: A Large-Sample Study

Air Force Military Medical University of People's Liberation Army

Status: Active, not recruiting

Conditions: Hypertrophic Obstructive Cardiomyopathy (HOCM)

Treatments: Procedure: Percutaneous Intramyocardial Septal Radiofrequency Ablation

Study type: Observational

Funder types: Other

Identifiers

NCT07003945

KY20242272-C-1

Details and patient eligibility

About

The Hypertrophic Cardiomyopathy Center of Xijing Hospital pioneered percutaneous intramyocardial septal radiofrequency ablation (PIMSRA) as an innovative treatment for hypertrophic obstructive cardiomyopathy (HOCM) to relieve left ventricular outflow tract obstruction. Clinical studies have confirmed PIMSRA's efficacy, safety and reliability, establishing it as a novel alternative for septal reduction therapy. As a novel interventional approach, comprehensive evaluation of its safety and therapeutic effectiveness is warranted.

Therefore, this retrospective study aims to:

• Investigate postoperative clinical outcomes and their influencing factors in HOCM patients undergoing PIMSRA;
• Analyze morphological and hemodynamic changes including: septal thickness, left ventricular outflow tract gradient, mid-ventricular pressure gradient and left ventricular flow field dynamics;
• Examine correlations between clinical/procedural parameters and clinical symptoms, quality of life and cardiac reverse remodeling indicators.

This study will provide high-quality evidence to support the clinical application of this novel procedure.

Enrollment: 800 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All HOCM patients who underwent PIMSRA treatment, including those with left ventricular outflow tract and middle ventricular obstruction;
• Age from 18 to 90 years old.

Exclusion criteria

• Patients lost to follow-up whose follow-up period did not reach 6 months;
• Incomplete clinical data affected statistical analysis.

Trial design

800 participants in 1 patient group

Hypertrophic Obstructive Cardiomyopathy Patients Underwent PIMSRA

Treatment:

Procedure: Percutaneous Intramyocardial Septal Radiofrequency Ablation