Clinical trial NCT03734562: Trial to Evaluate the Efficacy and Safety of Substrate Ablation of Monomorphic Ventricular Tachycardia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Monomorphic Ventricular Tachycardia
Keywords: Ventricular tachycardia
Ischemic cardiomyopathy
Catheter Ablation
Antiarrhythmic drug therapy
ICD
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
First posted: 2018-11-08
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Ischemic cardiomyopathy, with ischemic myocardial scar
* Sustained monomorphic ventricular tachycardia
* Age \> 18 years
* Prior ICD implantation

Exclusion Criteria:

* VT storm
* NYHA functional class IV
* Additional indication for antiarrhythmic drug therapy
* Contraindication for both study drugs (amiodarone and sotalol).
* Uncontrolled myocardial ischemia.
* LV thrombus.
* Non-ischemic VT substrate.
* Contraindications for anticoagulation.
* Prior substrate ablation in the previous 6 months
* Cr \> 2.5 mg/dL
* Mitral AND aortic mechanical valvular prosthesis

Primary outcomes:
measure: Occurrence of death from cardiovascular causes.
timeFrame: 2 years
measure: Occurrence of appropriate shocks for VT/VF
timeFrame: 2 years
measure: Occurrence of hospitalization for heart failure
timeFrame: 2 years
measure: Occurrence of severe complication of the ablation procedure.
timeFrame: 2 years
measure: Occurrence of interruption of antiarrhythmic drug therapy due to severe side effects
timeFrame: 2 years
Secondary outcomes:
measure: Number of patients with appropriate ICD therapies
timeFrame: 2 years
measure: Number of patients with inappropriate ICD therapies
timeFrame: 2 years
measure: Number of patients with appropriate ICD shocks
timeFrame: 2 years
measure: Number of patients with inappropriate ICD shocks
timeFrame: 2 years
measure: Quality of life measured with the The Short Form (36) Health Survey
timeFrame: 2 years
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital General UNiversitario Gregorio Marañon
Study officials:
affiliation: Hospital General Universitario Gregorio Marañon
name: Angel Arenal, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arenal A, Avila P, Jimenez-Candil J, Tercedor L, Calvo D, Arribas F, Fernandez-Portales J, Merino JL, Hernandez-Madrid A, Fernandez-Aviles FJ, Berruezo A. Substrate Ablation vs Antiarrhythmic Drug Therapy for Symptomatic Ventricular Tachycardia. J Am Coll Cardiol. 2022 Apr 19;79(15):1441-1453. doi: 10.1016/j.jacc.2022.01.050.