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NCT Number: NCT07003945

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hypertrophic Obstructive Cardiomyopathy (HOCM) Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ultrasound Medicine Department of Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Percutaneous Intramyocardial Septal Radiofrequency Ablation

Procedure

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.

Primary outcomes

  1. Major adverse cardiovascular events

    Time frame: Observations were conducted from the immediate postoperative period through 1-year follow-up, with assessment time points including but not limited to 1 month, 3 months, 6 months, and 1 year.

    Major adverse cardiovascular events including but not limited to:

    • All-cause death;
    • Arrhythmic events: resuscitated cardiac arrest or ventricular tachycardia/fibrillation, appropriate implantable cardioverter-defibrillator discharge, atrioventricular block, pacemaker implantation and atrial fibrillation;
    • Acute heart failure: acute pulmonary edema, new-onset NYHA class Ⅲ-IV symptoms, and heart failure-related hospitalization;
    • Cardiogenic shock: cardiac disorder that results in a systolic blood pressure <90 mmHg for ≥30 min (or the need for vasopressors, inotropes or mechanical circulatory support to maintain systolic blood pressure ≥90 mmHg) with evidence of hypoperfusion;
    • Severe systolic anterior motion: the proximal portion of the anterior mitral leaflet moved excessively close to the septum, resulting in extreme LVOT obstruction and acute haemodynamic collapse;
    • Cerebrovascular events: all stroke (ischemic or hemorrhagic) and transient ischemic attacks.

  2. Procedure-related adverse events

    Time frame: Observations were conducted from the immediate postoperative period through 1-year follow-up, with assessment time points including but not limited to 1 month, 3 months, 6 months, and 1 year.

    Any instrument or procedure-related complications, including but not limited to death, emergency surgery, pericardial tamponade requiring pericardiocentesis or surgery, bleeding, procedure-related stroke.

  3. Interventricular septal thickness

    Time frame: Observations were conducted from the immediate postoperative period through 1-year follow-up, with assessment time points including but not limited to 1 month, 3 months, 6 months, and 1 year.

    Maximum septal thickness as measured by echocardiography.

  4. Left ventricular outflow tract gradient

    Time frame: Observations were conducted from the immediate postoperative period through 1-year follow-up, with assessment time points including but not limited to 1 month, 3 months, 6 months, and 1 year.

    Left ventricular outflow tract gradient as measured by echocardiography.

Secondary outcomes

  1. New York Heart Association Classification

    Time frame: Observations were conducted from the immediate postoperative period through 1-year follow-up, with assessment time points including but not limited to 1 month, 3 months, 6 months, and 1 year.

    The New York Heart Association Classification involved 4 classes. I-No limitation of physical activity, II-Slight limitation of physical activity, III-Marked limitation of physical activity, IV-Unable to carry on any physical activity without discomfort. A higher grade means worse heart function.

  2. Kansas City Cardiomyopathy Questionnaire score

    Time frame: Observations were conducted from the immediate postoperative period through 1-year follow-up, with assessment time points including but not limited to 1 month, 3 months, 6 months, and 1 year.

    The Kansas City Cardiomyopathy Questionnaire was a 23-item, self-administered questionnaire that measure the participant's perception of their health status. It quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated from each domain and scaled from 0 to 100, where lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life.

  3. Late gadolinium enhancement

    Time frame: Observations were conducted from the immediate postoperative period through 1-year follow-up, with assessment time points including but not limited to 1 month, 3 months, 6 months, and 1 year.

    Late gadolinium enhancement measured by cardiac magnetic resonance.

  4. Mean blood pressure

    Time frame: Observations were conducted from the immediate postoperative period through 1-year follow-up, with assessment time points including but not limited to 1 month, 3 months, 6 months, and 1 year.

    Mean systolic/diastolic blood pressure measured by ambulatory blood pressure monitoring.

  5. Energy loss

    Time frame: Observations were conducted from the immediate postoperative period through 1-year follow-up, with assessment time points including but not limited to 1 month, 3 months, 6 months, and 1 year.

    Energy loss measured by vector flow mapping.

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 4, 2025
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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