A Prospective, Multicenter, Randomized, Parallel-Controlled Superiority Study Evaluating the Efficacy and Safety of a Transcatheter Intramyocardial Septal Radiofrequency Ablation System in Patients With Obstructive Hypertrophic Cardiomyopathy

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This is a prospective, multicenter, randomized, parallel-controlled, superiority clinical trial designed to evaluate the efficacy and safety of a transcatheter intramyocardial septal radiofrequency ablation system for the treatment of patients with obstructive hypertrophic cardiomyopathy (oHCM). Eligible participants will be randomized in a 2:1 ratio to receive either active ablation under intracardiac echocardiographic guidance or a sham procedure. All participants will continue to receive standard-of-care medical therapy during the study period. The primary endpoint is the treatment effectiveness rate at 6 months, defined as a ≥50% reduction in LVOT gradient from baseline or a resting LVOT gradient \<30 mmHg.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Age 18 to 80 years, regardless of sex

• Diagnosed with obstructive hypertrophic cardiomyopathy (oHCM)

• Presence of significant symptoms (e.g., dyspnea, chest pain, fatigue, palpitations, syncope)

• NYHA class II or higher with LVOTG ≥50 mmHg at rest or provoked (assessed by echocardiography)

• Septal thickness ≥15 mm

• Unsuitable for surgical myectomy or refusal of surgery

• Provided informed consent and agree to complete follow-up

Locations
Other Locations
China
Capital Medical University Affiliated Beijing Anzhen Hospital
RECRUITING
Beijing
Sir Run Run Shaw hospital
RECRUITING
Hangzhou
Contact Information
Primary
Yongxin Su
suyongxin@sinusmedtech.com
+86 18121015668
Time Frame
Start Date: 2025-07-20
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 124
Treatments
Experimental: Septal RF Ablation Group
Participants in this group will receive a transcatheter intramyocardial septal radiofrequency ablation under intracardiac echocardiography (ICE) guidance using the investigational device system. Standardized pharmacological therapy will be continued throughout the study period.
Sham_comparator: Sham Procedure (No RF Ablation)
Participants in this group will undergo a sham procedure under ICE guidance. The catheter will be inserted but no ablation will be performed. Participants will continue standardized pharmacological therapy throughout the study period. After completion of the 6-month follow-up, participants in this arm may voluntarily choose to receive the investigational treatment.
Sponsors
Leads: SuZhou Sinus Medical Technologies Co.,Ltd

This content was sourced from clinicaltrials.gov