Septal Ablation for Obstructive HCM

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertrophic Obstructive Cardiomyopathy (HOCM)
• Intervention / Treatment: Device: percutaneous intramyocardial septal radiofrequency ablation system

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yaxun Sun, MD; Phone Number: +86 15057173170; Email: sunyaxun@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310016
      • Sir Run Run Shaw Hospital
      • Contact: Yaxun Sun, MD; Phone Number: +86 15057173170; Email: sunyaxun@zju.edu.cn

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: percutaneous intramyocardial septal radiofrequency ablation system	Device: percutaneous intramyocardial septal radiofrequency ablation system; The device is introduced into the right ventricle and performs ablation treatment on the hypertrophic interventricular septum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success rate	Technical success rate: the radiofrequency ablation catheter reaches the required treatment site, successfully completes the ablation, and is successfully withdrawn from the body.	30-day
Short Form 36 (SF-36) health survey questionnaire	The life quality score of SF-36 would significantly improved after the procedure. The higher scores mean a better outcome.	90-day
Improvement of left ventricular outflow tract gradient (LVOTG)	The improvement of LVOTG at post-procedure,30 days,3 months and 6 months after procedure. If the pressure gradient is reduced, the symptom will improve.	6 months
Improvement of NYHA functional classification	The improvement of NYHA functional class at post-procedure,30 days,3 months and 6 months after procedure. The lower class mean a better outcome.	6 months
6-min walk distance	The increase of 6-min walk distance at post-procedure,30 days,3 months and 6 months after procedure.	6 months

Collaborators and Investigators

• Sponsor: SuZhou Sinus Medical Technologies Co.,Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): February 29, 2024
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: January 27, 2024
• First Submitted That Met QC Criteria: February 18, 2024
• First Posted (Actual): February 26, 2024

Study Record Updates

• Last Update Posted (Actual): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 18, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• 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: CNS2301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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