Clinical trial NCT06277960: Septal Ablation for Obstructive HCM
Official title: A Prospective, Single-center, Single-arm Clinical Study to Evaluate the Safety and Effectiveness of Percutaneous Intramyocardial Septal Radiofrequency Ablation System in the Treatment of Hypertrophic Obstructive Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypertrophic Obstructive Cardiomyopathy (HOCM)
Lead sponsor: SuZhou Sinus Medical Technologies Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2024-02-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. 18 years old ≤ age ≤ 75 years old, no gender limit.
2. 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.
3. Subject with New York Heart Association (NYHA) cardiac function ≥ II grade.
4. Subject with adequate drug treatment is not effective or cannot tolerate side effects of the drug.
5. 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.

Exclusion Criteria:

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

Primary outcomes:
measure: 30-day major adverse clinical events (MACE)
timeFrame: 30-day
Secondary outcomes:
measure: Technical success rate
timeFrame: 30-day
measure: Short Form 36 (SF-36) health survey questionnaire
timeFrame: 90-day
measure: Improvement of left ventricular outflow tract gradient (LVOTG)
timeFrame: 6 months
measure: Improvement of NYHA functional classification
timeFrame: 6 months
measure: 6-min walk distance
timeFrame: 6 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
state: Zhejiang
Study officials:
References: