REFINE-HCM: Intramyocardial Septal Radiofrequency Ablation for Obstructive Hypertrophic Cardiomyopathy
Recruiting
N/A
Interventional Study
Hypertrophic Cardiomyopathy, Obstructive
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 124 (estimated)
- Sponsor
- SuZhou Sinus Medical Technologies Co.,Ltd · Industry
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About This Trial
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 intraca…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 e…
Contacts