Rationale and design of the TAILOR-HCM multicenter randomized controlled trial: Transapical beating-heart septal myectomy for obstructive hypertrophic cardiomyopathy.

BACKGROUND

Septal myectomy is the gold standard treatment for drug-refractory obstructive hypertrophic cardiomyopathy (oHCM). However, conventional septal myectomy (CSM) has been largely confined to specialized centers owing to its technical complexity. Transapical beating-heart septal myectomy (TA-BSM) can simplify CSM, enabling minimally invasive tailored septal resections in the beating heart under real-time echocardiographic guidance. Despite single-institution experience showed favorable efficacy and safety, whether TA-BSM can achieve similar clinical outcomes as CSM remains unknown since randomized controlled trial comparing the 2 approaches was unavailable.

METHODS

The TAILOR-HCM trial (Transapical Beating-Heart Septal Myectomy vs Conventional Surgical Myectomy in Patients with Obstructive Hypertrophic Cardiomyopathy) is a multicenter, randomized, controlled, assessor-blinded, noninferiority trial evaluating the safety and efficacy of a novel device-based TA-BSM procedure conducted at 11 experienced CSM centers in China. In total, 216 symptomatic patients with oHCM who meet guideline-directed indications for septal myectomy will be randomly assigned in a 1:1 ratio to TA-BSM or CSM. The primary endpoint is relief of left ventricular outflow tract (LVOT) obstruction at 12 months, defined as a resting LVOT gradient <30 mm Hg and a standardized Valsalva maneuver-provoked LVOT gradient <50 mm Hg. Secondary endpoints include cardiac hemodynamic and structural parameters, procedure-related outcomes, quality of life, and laboratory examinations. The key safety outcome is all-cause mortality within 12 months after surgery.

CONCLUSIONS

TAILOR-HCM is the first multicenter randomized controlled trial evaluating both TA-BSM and CSM in oHCM. Through comparative evidence against CSM, this study will inform future clinical decision-making. If noninferior hemodynamic efficacy with favorable safety is confirmed, TA-BSM may represent an alternative surgical approach that expands therapeutic options and improves access to definitive septal reduction therapy for patients with oHCM.

CLINICAL TRIAL REGISTRATION: https://www.chictr.org.cn. Unique Identifier: ChiCTR2400087414.