NCT06224621

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Obstructive Hypertrophic Cardiomyopathy

Interventions

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

Timeline

• Start date: 2024-01-31
• Primary completion: 2026-01-31
• Completion: 2026-01-31
• First posted: 2024-01-25
• Last updated: 2024-05-20

Locations

1 site across 1 country: China