Echocardiography-guided Percutaneous Septal Radiofrequency Ablation for Obstructive HCM After Alcohol Septal Ablation

NCT06496633 | Active Not Recruiting DMC

• 1 other identifier: KY20242206-C-1
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

After alcohol ablation, some HOCM patients have serious clinical symptoms and adverse complications, and need to undergo invasive surgery again when adequate drug therapy is not effective or cannot tolerate the side effects of drugs. Liwen surgery is a safe and effective new minimally invasive treatment for HOCM patients, so the purpose of this study was to evaluate the safety and efficacy of Liwen surgery in HOCM patients who failed alcohol ablation and provide new treatment methods for patients.

Conditions

Hypertrophic Cardiomyopathy

Keywords

Percutaneous Intramyocardial Septal Radiofrequency Ablation; Hypertrophic Cardiomyopathy; Alcohol Septal Ablation

Outcome Measures

Primary Outcomes (1)

• treatment success rate

  For survival, the left ventricular outflow tract pressure gradient (LVOT pressure gradient) decreased by ≥ 50% or the resting left ventricular outflow tract pressure gradient (LVOT pressure gradient) was \< 30 mmHg

  Six months after procedure.

Study Arms (1)

cohort :Hypertrophic Cardiomyopathy patients with residual obstruction after Alcohol Septal Ablation

All patients performed procedure of Percutaneous Intramyocardial Septal Radiofrequency Ablation

Procedure: Percutaneous Intramyocardial Septal Radiofrequency Ablation

Interventions

Percutaneous Intramyocardial Septal Radiofrequency Ablation PROCEDURE

PIMSRA procedure represents a significant breakthrough in the treatment of HOCM patients, as it uses a unique transmyocardial approach to directly and precisely insert a radiofrequency electrode needle into the hypertrophied IVS for targeted ablation

cohort :Hypertrophic Cardiomyopathy patients with residual obstruction after Alcohol Septal Ablation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with obstructive hypertrophic cardiomyopathy who underwent Liwen surgery at the Multidisciplinary Diagnosis and Treatment and Genetic Counseling Center for Hypertrophic Cardiomyopathy at Xijing Hospital of the Air Force Military Medical University from January 2017 to August 2023, all of whom had a history of alcohol ablation

You may qualify if:

• The patient is at least 18 years of age.
• Hypertrophic cardiomyopathy with alcohol ablation, LVOT pressure difference at rest or after excitation ≥ 50mmHg;
• The clinical symptoms are obvious, fatigue, shortness of breath, exhaustive angina pectoris, syncope, etc. seriously affect the quality of life, and the effect of adequate drug treatment is not good or the side effects of drugs cannot be tolerated;
• After the informed consent of the patient and his family, he voluntarily underwent Liwen surgery.

You may not qualify if:

• Non-obstructive hypertrophic cardiomyopathy;
• Left ventricular hypertrophy due to secondary causes, such as increased preload, history of taking drugs suspected of causing left ventricular hypertrophy, etc.
• Preoperative complications with other heart diseases require surgical treatment.
• The disease will make it difficult to evaluate treatment (e.g. cancer, severe metabolic diseases, mental illness, etc.).
• Patients who have participated in any clinical trial of drugs and/or medical devices within 1 month before surgery or during follow-up;
• Pregnant and breastfeeding women;
• Patients with poor adherence may not cooperate during treatment or follow-up.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Ultrasonic Diagnosis Department of Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Location

Related Publications (1)

• Zhang J, Hsi DH, Ta S, Wang J, Wang B, Ma H, Shan B, Hu R, Li J, Liu L. Percutaneous Intramyocardial Septal Radiofrequency Ablation for Hypertrophic Cardiomyopathy With Residual Obstruction After Alcohol Septal Ablation. Can J Cardiol. 2025 Dec;41(12):2397-2406. doi: 10.1016/j.cjca.2025.08.355. Epub 2025 Sep 25.

  PMID: 41015247 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

We collected 10 ml of peripheral venous blood from the HCM patient and extracted the genome from the isolated white blood cells using The Relax Gene Blood DNA System (cat. no. DP319; Tiangen Biotech Co, Ltd., Beijing, China). After gene extraction, 96 cardio-disease-related genes were analyzed by an experienced genetic Counselor.

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: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 11, 2024
• Study Start: March 26, 2024
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 11, 2024

Record last verified: 2024-03

Locations

CN (1)