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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ablation | Experimental | Substrate-based radiofrequency catheter ablation |
|
| Antiarrhythmic drug therapy | Active Comparator | Antiarrhythmic drug therapy; amiodarone or sotalol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ablation | Procedure | Substrate-based radiofrequency catheter ablation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of death from cardiovascular causes. | - 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 | 2 years |
| Occurrence of appropriate shocks for VT/VF | 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). | 2 years |
| Occurrence of hospitalization for heart failure | - 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). | 2 years |
| Occurrence of severe complication of the ablation procedure. | Occurrence of severe complications of the ablation procedure Will be identified through review of patient clinical reports | 2 years |
| Occurrence of interruption of antiarrhythmic drug therapy due to severe side effects | Occurrence of severe complications of the ablation procedure Will be identified through review of patient clinical reports | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with appropriate ICD therapies | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angel Arenal, MD, PhD | Hospital General Universitario Gregorio Marañon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General UNiversitario Gregorio Marañon | Madrid | 28009 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37366571 | Derived | Avila P, Berruezo A, Jimenez-Candil J, Tercedor L, Calvo D, Arribas F, Fernandez-Portales J, Merino JL, Hernandez-Madrid A, Fernandez-Aviles F, Arenal A. Bayesian analysis of the Substrate Ablation vs. Antiarrhythmic Drug Therapy for Symptomatic Ventricular Tachycardia trial. Europace. 2023 Jul 4;25(7):euad181. doi: 10.1093/europace/euad181. | |
| 35422240 |
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| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| D000889 | Anti-Arrhythmia Agents |
| D000638 | Amiodarone |
| D013015 | Sotalol |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
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ICD therapy analysis and outcome adjudication is performed by physicians blinded to the study group.
| Antiarrhythmic drug | Drug | Amiodarone or sotalol therapy |
|
|
| 2 years |
| Number of patients with inappropriate ICD therapies | 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 electrophysiologists | 2 years |
| Number of patients with appropriate ICD shocks | 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 | 2 years |
| Number of patients with inappropriate ICD shocks | 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 | 2 years |
| Quality of life measured with the The Short Form (36) Health Survey | 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 disability | 2 years |
| 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. |
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013514 |
| Surgical Procedures, Operative |
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |