Septal Ablation for Obstructive HCM

Phase

N/A

Condition

Circulation Disorders

Treatment

percutaneous intramyocardial septal radiofrequency ablation system

Clinical Study ID

NCT06277960

CNS2301

Ages 18-75
All Genders

Study Summary

Hypertrophic cardiomyopathy (HCM) is a common clinical genetic-related disease, with a global incidence of 0.2%-0.5%, but only a few cases (10-20%) have been clinically diagnosed. About 70% of them are hypertrophic obstructive cardiomyopathy (HOCM), these HOCM patients have significant clinical symptoms, including progressively increasing fatigue, angina, exertional dyspnea, and syncope. Conservative medications are used to treat the vast majority of patients. Invasive therapy, which includes surgical myectomy, percutaneous transluminal septal myocardial ablation(PTSMA), percutaneous intramyocardial septal radiofrequency ablation (PIMSRA) and percutaneous endocardial septal radiofrequency ablation (PESA) is introduced to patients with refractory symptoms or drug resistance. However, surgical operations are complicated and high risk procedures with high mortality. Interventional approaches are very difficult to perform and therefore the application is limited.

Previous researches have shown that interventricular septal radiofrequency ablation could effectively reduce the left ventricular outflow tract pressure gradient (LVOTG), thereby treating obstructive hypertrophic cardiomyopathy (HOCM). This device is based on the same radiofrequency ablation energy principle, however, the catheter is introduced into the right ventricle and performs ablation treatment on the hypertrophic interventricular septum, which is potentially a lower risk route of access for septal ablation than currently attempted interventional approaches.

The purpose of this study is to evaluate the safety and efficacy of percutaneous intramyocardial septal ablation catheters in the treatment of obstructive hypertrophic cardiomyopathy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

18 years old ≤ age ≤ 75 years old, no gender limit.
Subject has pressure gradient of left ventricular outflow tract (LVOT) ≥50 mmHg（withSystolic Anterior Motion）in the resting-state or after exercise stress test.
Subject with New York Heart Association (NYHA) cardiac function ≥ II grade.
Subject with adequate drug treatment is not effective or cannot tolerate sideeffects of the drug.
Subject was informed of the nature of the clinical study and agreed to participatein all the requirements of the clinical study, signed an ethics committee-approvedinformed consent form before conducting any special examinations and/or treatmentsrelated to the clinical study.

Exclusion

Exclusion Criteria:

Subject is pregnant, lactating, or planned to conceive during a clinical study.
Subject with interventricular septal thickness ≥ 30mm.
Subject has undergone other ventricular septal volume reduction surgeries.
Subject with complete right bundle branch block on electrocardiogram.
Subject with Sudden Cardiac Death Index ≥ 10%.
Subject combined with other heart diseases requires surgical treatment.
Subject with heart failure(Defined as resting heart failure after intensiveanti-heart failure therapy, left ventricular fraction of ejecting< 40%).
Subject is mentally incapacitated or unable to understand the study requirements.
Subject has participated in other clinical trials within 3 months.
The investigator determines that there is any situation that affects the safety ofthe subjects or interferes with the evaluation of test results.

Study Design

percutaneous intramyocardial septal radiofrequency ablation system

March 28, 2024

June 30, 2026

Connect with a study center

Sir Run Run Shaw Hospital
Hangzhou, Zhejiang 310016
China
Site Not Available

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