NCT07003945

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

Clinical Outcomes of Percutaneous Intramyocardial Septal Radiofrequency Ablation Treating for Hypertrophic Obstructive Cardiomyopathy: A Large-Sample Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 800 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hypertrophic Obstructive Cardiomyopathy (HOCM)

Interventions

Type	Name	Description
PROCEDURE	Percutaneous Intramyocardial Septal Radiofrequency Ablation	With the real-time guidance of TTE, a radiofrequency electrode needle was percutaneously inserted via the transapical intramyocardial approach into the hypertrophied septum for thermal ablation. Intraoperative TTE and 12-lead electrocardiographic monitoring were employed to assess the ablation extent and prevent vascular and cardiac conduction bundle injury. The success of ablation was confirmed by evaluating contrast medium perfusion defects in the ablated areas and comparing them with the preprocedural hypertrophied septum.

Timeline

• Start date: 2025-04-29
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2025-06-04
• Last updated: 2025-06-04

Locations

1 site across 1 country: China