Condition: Hypertrophic Cardiomyopathy, Obstructive · Sponsor: SuZhou Sinus Medical Technologies Co.,Ltd
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.
This description comes directly from the study's public registry record.
Yongxin Su · +86 18121015668 · suyongxin@sinusmedtech.com
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| Capital Medical University Affiliated Beijing Anzhen Hospital | Beijing, Beijing Municipality, China | Recruiting |
| Sir Run Run Shaw hospital | Hangzhou, Zhejiang, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07006493