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

NCT07003945 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 800

Last updated 2025-06-04

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Xijing Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-29
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07003945 on ClinicalTrials.gov