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Rationale and design of the TAILOR-HCM multicenter randomized controlled trial: Transapical beating-heart septal
Jing Fang1, Yilei Ma1, Yue Chen1
1Division of Cardiovascular Surgery, Department of Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Hubei Engineering Research Center for Diagnostic and Therapeutic Equipment in Precision Cardiovascular Surgery, Wuhan, China; Key Laboratory of Organ Transplantation, Ministry of Education; NHC Key Laboratory of Organ Transplantation; Key Laboratory of Organ Transplantation, Chinese Academy of Medical Sciences; Organ Transplantation Clinical Medical Research Center of Hubei Province, Wuhan, China.
Insights
The TAILOR-HCM trial compares transapical beating-heart septal myectomy (TA-BSM) to conventional septal myectomy (CSM) for obstructive hypertrophic cardiomyopathy (oHCM). This study will determine if TA-BSM is a safe and effective alternative to CSM.
Area of Science:
- Cardiology
- Cardiac Surgery
- Medical Devices
Background:
- Septal myectomy is the standard treatment for drug-refractory obstructive hypertrophic cardiomyopathy (oHCM).
- Conventional septal myectomy (CSM) is technically complex and limited to specialized centers.
- Transapical beating-heart septal myectomy (TA-BSM) offers a less invasive approach under echocardiographic guidance.
Purpose of the Study:
- To evaluate the safety and efficacy of TA-BSM compared to CSM in patients with oHCM.
- To determine if TA-BSM is noninferior to CSM in relieving left ventricular outflow tract (LVOT) obstruction.
- To assess secondary outcomes including hemodynamic parameters, quality of life, and safety.
Main Methods:
- The TAILOR-HCM trial is a multicenter, randomized, controlled, assessor-blinded, noninferiority trial.
- 216 symptomatic oHCM patients were randomized 1:1 to TA-BSM or CSM.
- The primary endpoint is LVOT obstruction relief at 12 months (resting gradient <30 mm Hg, Valsalva <50 mm Hg).
Main Results:
- This section will report the findings of the TAILOR-HCM trial once available.
- Key outcomes include comparative analysis of LVOT obstruction relief between TA-BSM and CSM.
- Safety outcomes, including all-cause mortality, will be assessed at 12 months.
Conclusions:
- TAILOR-HCM is the first multicenter randomized trial comparing TA-BSM and CSM for oHCM.
- The study aims to provide evidence for TA-BSM as a potential alternative surgical approach.
- If proven effective and safe, TA-BSM could expand treatment options for oHCM patients.
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.
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