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

Efficacy and Safety of Echocardiography-guided Percutaneous Intraventricular Septal Radiofrequency Ablation for Obstructive Hypertrophic Cardiomyopathy After Alcohol Septal Ablation

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hypertrophic Cardiomyopathy
• Intervention / Treatment: Procedure: Percutaneous Intramyocardial Septal Radiofrequency Ablation

Detailed Description

Hypertrophic cardiomyopathy (HCM) is the most common inherited cardiovascular disease, mostly due to mutations in the gene encoding myocardial sarcomere contractile protein, with an incidence of about 1:500-1:200. HCM is the main cause of sudden cardiac death in young people and athletes. Its clinical manifestations are highly heterogeneous. Some patients have no obvious symptoms or mild symptoms, but some patients have obvious myocardial hypertrophy in the early stage, resulting in chest tightness, chest pain, breathing difficulties, syncope, heart failure, and even sudden cardiac death. The annual mortality rate of HCM patients is about 1.4% -2.2%. Alcohol septal ablation (ASA) is a kind of interventional therapy. Its principle is to inject anhydrous alcohol through a catheter, occlude the septal branch of the coronary artery, make the hypertrophic ventricular septal myocardium that dominates it ischemic, necrosis, thinning, and contractility decrease, so that the obstruction of the outflow tract disappears or alleviates, thereby improving the clinical symptoms of patients. However, HOCM patients often have serious clinical symptoms and adverse complications after alcohol ablation, and invasive surgical treatment is required when adequate drug therapy is not effective or cannot tolerate the side effects of drugs. Liwen surgery is a safe and effective new path to treat minimally invasive HOCM patients, so the purpose of this study was to evaluate the safety and efficacy of Liwen surgery after alcohol ablation in HOCM patients, and to verify its early postoperative efficacy.

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Ultrasonic Diagnosis Department of Xijing Hospital, Fourth Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

Inclusion Criteria:

1. The patient is at least 18 years of age.
2. Hypertrophic cardiomyopathy with alcohol ablation, LVOT pressure difference at rest or after excitation ≥ 50mmHg;
3. 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;
4. After the informed consent of the patient and his family, he voluntarily underwent Liwen surgery.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Xijing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2024
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: July 4, 2024
• First Submitted That Met QC Criteria: July 4, 2024
• First Posted (Actual): July 11, 2024

Study Record Updates

• Last Update Posted (Actual): July 11, 2024
• Last Update Submitted That Met QC Criteria: July 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Hypertrophic Cardiomyopathy; Alcohol Septal Ablation; Percutaneous Intramyocardial Septal Radiofrequency Ablation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Hypertrophy; Cardiomyopathies; Cardiomyopathy, Hypertrophic
• Other Study ID Numbers: KY20242206-C-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No