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

NCT07003945 | Active Not Recruiting

• 1 other identifier: KY20242272-C-1
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Cardiomyopathy, hypertrophic; Treatment outcome; safety; efficacy; Percutaneous intramyocardial septal radiofrequency ablation

Outcome Measures

Primary Outcomes (4)

• Major adverse cardiovascular events

  Major adverse cardiovascular events including but not limited to: 1. All-cause death; 2. Arrhythmic events: resuscitated cardiac arrest or ventricular tachycardia/fibrillation, appropriate implantable cardioverter-defibrillator discharge, atrioventricular block, pacemaker implantation and atrial fibrillation; 3. Acute heart failure: acute pulmonary edema, new-onset NYHA class Ⅲ-IV symptoms, and heart failure-related hospitalization; 4. 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; 5. 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; 6. Cerebrovascular events: all stroke (ischemic or hemorrhagic) and transient ischemic attacks.

  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.

• Procedure-related adverse events

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

  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.

• Interventricular septal thickness

  Maximum septal thickness as measured by echocardiography.

  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

  Left ventricular outflow tract gradient as measured by echocardiography.

  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.

Secondary Outcomes (5)

• New York Heart Association Classification

  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.

• Kansas City Cardiomyopathy Questionnaire score

  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

  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 blood pressure

  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

  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.

Study Arms (1)

Hypertrophic Obstructive Cardiomyopathy Patients Underwent PIMSRA

Procedure: Percutaneous Intramyocardial Septal Radiofrequency Ablation

Interventions

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.

Hypertrophic Obstructive Cardiomyopathy Patients Underwent PIMSRA

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are diagnosed with HOCM and with drug-refractory symptoms underwent PIMSRA in Xijing Hospital from 2016 to 2025.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Ultrasound Medicine Department of Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: June 4, 2025
• Study Start: April 29, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)