NCT03734562

Trial to Evaluate the Efficacy and Safety of Substrate Ablation of Monomorphic Ventricular Tachycardia

Randomized Controlled Phase IV Multicentric Trial, Comparing the Efficacy and Safety of Radiofrequency Substrate Ablation of Monomorphic Ventricular Tachycardia vs. Antiarrhyhtmic Drugs in Patients Experiencing Appropriate ICD Shocks

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Hospital General Universitario Gregorio Marañon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To compare the efficacy and safety of substrate-based radiofrequency catheter ablation vs. antiarrhythmic drug therapy in patients with ischemic cardiomyopathy and scar-related sustained monomorphic ventricular tachycardia.

Detailed description

Sustained monomorphic ventricular tachycardia remains an important source of morbidity and mortality in patients surviving a myocardial infarction. ICD´s have been proven to reduce mortality in this patients population, nonetheless, recurrent arrhythmia and ICD shocks are known to negatively impact ventricular function and are associated with worsening heart failure and mortality. We devised a controlled, randomized, parallel, single blind, phase IV clinical trial with the aim of comparing the efficacy and safety of substrate-based radiofrequency catheter ablation vs. antiarrhythmic drug therapy in patients with ischemic cardiomyopathy and scar-related sustained monomorphic ventricular tachycardia, implanted with an ICD.

Conditions

• Monomorphic Ventricular Tachycardia

Interventions

Type	Name	Description
PROCEDURE	Ablation	Substrate-based radiofrequency catheter ablation
DRUG	Antiarrhythmic drug	Amiodarone or sotalol therapy

Timeline

• Start date: 2010-07-01
• Primary completion: 2017-09-29
• Completion: 2017-09-30
• First posted: 2018-11-08
• Last updated: 2019-03-15

Locations

1 site across 1 country: Spain