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NCT07003945Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 4 Jun 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
800 (estimated)
First submitted
30 Apr 2025
Start date
29 Apr 2025
Primary completion date
30 Jun 2027
Lead sponsor
Xijing Hospital
NCT number
NCT07003945

What you commit to

  • Study type: Observational
  • Planned participants: 800
  • From 29 Apr 2025 to the primary completion date, 30 Jun 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

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

Who the study is looking for

  • 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.

Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ultrasound Medicine Department of Xijing Hospital, Fourth Military Medical University
Coordinator of this site? Confirm its status
Xi'anChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.