Septal Ablation for Obstructive HCM

NCT06277960 | Active Not Recruiting

• 1 other identifier: CNS2301
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertrophic Obstructive Cardiomyopathy (HOCM)

Outcome Measures

Primary Outcomes (1)

• 30-day major adverse clinical events (MACE)

  30-day major adverse clinical events (MACE), including death, emergency surgery, severe pericardial effusion bleeding requiring pericardiocentesis or surgery, atrioventricular block, heart perforation, and surgery-related stroke.

  30-day

Secondary Outcomes (5)

• Technical success rate

  30-day

• Short Form 36 (SF-36) health survey questionnaire

  90-day

• Improvement of left ventricular outflow tract gradient (LVOTG)

  6 months

• Improvement of NYHA functional classification

  6 months

• 6-min walk distance

  6 months

Study Arms (1)

percutaneous intramyocardial septal radiofrequency ablation system

EXPERIMENTAL

Device: percutaneous intramyocardial septal radiofrequency ablation system

Interventions

percutaneous intramyocardial septal radiofrequency ablation system DEVICE

The device is introduced into the right ventricle and performs ablation treatment on the hypertrophic interventricular septum.

percutaneous intramyocardial septal radiofrequency ablation system

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old ≤ age ≤ 75 years old, no gender limit.
• Subject has pressure gradient of left ventricular outflow tract (LVOT) ≥50 mmHg（with Systolic 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 side effects of the drug.
• Subject was informed of the nature of the clinical study and agreed to participate in all the requirements of the clinical study, signed an ethics committee-approved informed consent form before conducting any special examinations and/or treatments related to the clinical study.

You may not qualify if:

• 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 intensive anti-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 of the subjects or interferes with the evaluation of test results.

Sponsors & Collaborators

• SuZhou Sinus Medical Technologies Co.,Ltd: lead

Study Sites (1)

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310016, China

Location

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: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2024
• First Posted: February 26, 2024
• Study Start: March 28, 2024
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 30, 2025

Record last verified: 2025-05

Locations

CN (1)