Trial to Evaluate the Efficacy and Safety of Substrate Ablation of Monomorphic Ventricular Tachycardia
- Conditions
- Monomorphic Ventricular Tachycardia
- Interventions
- Drug: Antiarrhythmic drugProcedure: Ablation
- Registration Number
- NCT03734562
- Lead Sponsor
- Hospital General Universitario Gregorio Marañon
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 180
- Ischemic cardiomyopathy, with ischemic myocardial scar
- Sustained monomorphic ventricular tachycardia
- Age > 18 years
- Prior ICD implantation
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Antiarrhythmic drug therapy Antiarrhythmic drug Antiarrhythmic drug therapy; amiodarone or sotalol Ablation Ablation Substrate-based radiofrequency catheter ablation
- Primary Outcome Measures
Name Time Method Occurrence of hospitalization for heart failure 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. 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 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. 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 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 Outcome Measures
Name Time Method Number of patients with inappropriate ICD therapies 2 years Occurrence of ICD therapies 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).
Appropriateness of ICD therapies is established by device-stored electrogram analysis performed by two expert independent electrophysiologistsNumber of patients with appropriate ICD therapies 2 years Occurrence of appropriate ICD therapies 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). Appropriateness of ICD therapies is established by device-stored electrogram analysis performed by two expert independent electrophysiologists
Number of patients with inappropriate ICD shocks 2 years Occurrence of ICD shocks 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).
Appropriateness of ICD shocks is established by device-stored electrogram analysis performed by two expert independent electrophysiologistsQuality of life measured with the The Short Form (36) Health Survey 2 years Quality of life is measured with the The Short Form (36) Health Survey at pre-specified study follow-up visits (3,6,12,24 months).
The short-form (36) health survey consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disabilityNumber of patients with appropriate ICD shocks 2 years Occurrence of ICD shocks 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).
Appropriateness of ICD shocks is established by device-stored electrogram analysis performed by two expert independent electrophysiologists
Trial Locations
- Locations (1)
Hospital General UNiversitario Gregorio Marañon
🇪🇸Madrid, Spain