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NOT YET RECRUITING
NCT06856265
NA

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

Sponsor: Shanghai Chest Hospital

View on ClinicalTrials.gov

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:

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-02-26

Completion Date

2025-12-01

Last Updated

2025-03-04

Healthy Volunteers

No

Interventions

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.