NCT06856265

Efficacy of Mavacamten Combined With Radiofrequency Ablation in Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the efficacy and safety of Mavacamten combined with radiofrequency ablation compared to Mavacamten alone in patients with symptomatic obstructive hypertrophic cardiomyopathy (HOCM). Participants were randomized into two groups:

Detailed description

This study aims to evaluate the efficacy and safety of Mavacamten combined with radiofrequency ablation compared to Mavacamten alone in patients with symptomatic obstructive hypertrophic cardiomyopathy (HOCM). Participants were randomized into two groups: Group 1: Mavacamten monotherapy Group 2: Mavacamten + Radiofrequency Ablation

Conditions

• Obstructive Hypertrophic Cardiomyopathy
• Mavacamten
• Radiofrequency Ablation

Interventions

Type	Name	Description
PROCEDURE	radiofrequency ablation	Radiofrequency Ablation is a minimally invasive interventional technique performed via catheter guidance. It utilizes thermal energy (50-80°C) generated by high-frequency alternating current (typically 300-750 kHz) to induce coagulative necrosis or electrophysiological isolation in targeted tissues, thereby eliminating abnormal electrical activity or mechanical obstruction. In the treatment of cardiomyopathy, RFA is applied to ablate hypertrophied myocardial tissue (e.g., the ventricular septum) to alleviate left ventricular outflow tract (LVOT) obstruction.
DRUG	Mavacamten	Initial Dose: Both groups received a starting dose of Mavacamten 2.5 mg orally once daily. Dose Titration: Adjustments were made based on a previously published titration protocol, guided by correlations among resting left ventricular ejection fraction (LVEF), LVOT gradient during Valsalva maneuver, and pre-dose Mavacamten plasma concentrations.

Timeline

• Start date: 2025-02-26
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2025-03-04
• Last updated: 2025-03-04