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
Overview
- Phase
- Not Applicable
- Intervention
- Ablation
- Conditions
- Monomorphic Ventricular Tachycardia
- Sponsor
- Hospital General Universitario Gregorio Marañon
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Occurrence of hospitalization for heart failure
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Ischemic cardiomyopathy, with ischemic myocardial scar
- •Sustained monomorphic ventricular tachycardia
- •Age \> 18 years
- •Prior ICD implantation
Exclusion Criteria
- •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
Arms & Interventions
Ablation
Substrate-based radiofrequency catheter ablation
Intervention: Ablation
Antiarrhythmic drug therapy
Antiarrhythmic drug therapy; amiodarone or sotalol
Intervention: Antiarrhythmic drug
Outcomes
Primary Outcomes
Occurrence of hospitalization for heart failure
Time Frame: 2 years
- Hospitalization for heart failure requiring overnight hospital stay and either increased oral diuretics or intravenous diuretics (at least 40 mg od frusemide or 10 mg od torasemide).
Occurrence of severe complication of the ablation procedure.
Time Frame: 2 years
Occurrence of severe complications of the ablation procedure Will be identified through review of patient clinical reports
Occurrence of interruption of antiarrhythmic drug therapy due to severe side effects
Time Frame: 2 years
Occurrence of severe complications of the ablation procedure Will be identified through review of patient clinical reports
Occurrence of death from cardiovascular causes.
Time Frame: 2 years
- Cause of death will be established by evaluation of medical records by an endpoints adjudication committee. Cardiovascular death includes: sudden death, death due to worsening heart failure or death due to myocardial infarction
Occurrence of appropriate shocks for VT/VF
Time Frame: 2 years
Occurrence of appropriate shocks for VT/VF VT is measured by ICD interrogation, which is routinely done at the following follow-up visits: after the VT ablation procedure, or in case of suspected arrhythmic symptoms (palpitations, syncope or presyncope).
Secondary Outcomes
- Number of patients with inappropriate ICD therapies(2 years)
- Number of patients with appropriate ICD therapies(2 years)
- Number of patients with inappropriate ICD shocks(2 years)
- Quality of life measured with the The Short Form (36) Health Survey(2 years)
- Number of patients with appropriate ICD shocks(2 years)