Clinical trial NCT07003945: Clinical Outcomes of PIMSRA Treating for Hypertrophic Obstructive Cardiomyopathy: A Large-Sample Study
Official title: Clinical Outcomes of Percutaneous Intramyocardial Septal Radiofrequency Ablation Treating for Hypertrophic Obstructive Cardiomyopathy: A Large-Sample Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hypertrophic Obstructive Cardiomyopathy (HOCM)
Keywords: Cardiomyopathy, hypertrophic
Treatment outcome
safety
efficacy
Percutaneous intramyocardial septal radiofrequency ablation
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Major adverse cardiovascular events
timeFrame: 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.
measure: Procedure-related adverse events
timeFrame: 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.
measure: Interventricular septal thickness
timeFrame: 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.
measure: Left ventricular outflow tract gradient
timeFrame: 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:
measure: New York Heart Association Classification
timeFrame: 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.
measure: Kansas City Cardiomyopathy Questionnaire score
timeFrame: 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.
measure: Late gadolinium enhancement
timeFrame: 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.
measure: Mean blood pressure
timeFrame: 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.
measure: Energy loss
timeFrame: 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.
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Ultrasound Medicine Department of Xijing Hospital, Fourth Military Medical University
state: Shaanxi
Study officials:
References: