Percutaneous Endocardial Septal Radiofrequency Ablation in Obstructive Hypertrophic Cardiomyopathy

Percutaneous Endocardial Septal Radiofrequency Ablation in the Treatment of Obstructive Hypertrophic Cardiomyopathy: a Prospective, Multicenter, Single-arm Objective Performance Criteria Trial

This prospective, multicenter, single-arm objective performance criteria trial is designed to assess the efficacy and safety of the Percutaneous Endocardial Septal Radiofrequency Ablation (PESA) procedure in the treatment of obstructive hypertrophic cardiomyopathy (oHCM). The primary objectives include investigating:

1. the treatment efficacy and safety of PESA treatment in oHCM patients with either left ventricular outflow tract obstruction (LVOTO) or midventricular obstruction;
2. the impact of PESA treatment on the functional capacity, quality of life and long-term prognosis of oHCM patients with either LVOTO or midventricular obstruction.

Inclusion Criteria:

• Patients with a diagnosis of hypertrophic cardiomyopathy;
• At least 18 years old;
• The presence of a resting or maximum provoked LVOT/midventricular gradient of ≥50 mmHg with symptoms, despite maximum tolerated medical therapy;
• Willing to receive PESA treatment;
• LVEF≥55%;
• Signed and dated written informed consent and willing to return for clinical follow-up.

Exclusion Criteria:

• Midventricular obstruction rendered by isolated papillary muscle hypertrophy;
• Complete right bundle branch block;
• Acute decompensation heart failure with NYHA IV;
• Previous septal reduction therapy including surgical and interventional procedures;
• Combination of other diseases requiring surgical treatment (including but not limited to coronary artery bypass grafting and apical aneurysm);
• Contraindications of radiofrequency ablation procedure;
• Women who are pregnant or lactating, or who plan to become pregnant while in the trial;
• Currently enrolled in another investigational device or drug trial;
• Combining any other clinical condition with a life expectancy less than 1 year.