Percutaneous Endocardial Septal Radiofrequency Ablation in Obstructive Hypertrophic Cardiomyopathy

National Center for Cardiovascular Diseases

Status: Enrolling

Conditions: Obstructive Hypertrophic Cardiomyopathy

Treatments: Procedure: Percutaneous Endocardial Septal Radiofrequency Ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT06224621

2023-ZX012

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Study group

Experimental group

Description:

Percutaneous Endocardial Septal Radiofrequency Ablation (PESA) is used to ablatethe hypertrophied septum of obstructive hypertrophic cardiomyopathy (oHCM) patients.

Treatment:

Procedure: Percutaneous Endocardial Septal Radiofrequency Ablation