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

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.

Study Overview

• Status: Completed
• Conditions: Monomorphic Ventricular Tachycardia
• Intervention / Treatment: Procedure: Ablation; Drug: Antiarrhythmic drug

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.

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28009
    • Hospital General Universitario Gregorio Maranon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ablation; Substrate-based radiofrequency catheter ablation	Procedure: Ablation; Substrate-based radiofrequency catheter ablation; Other Names: Catheter Ablation
Active Comparator: Antiarrhythmic drug therapy; Antiarrhythmic drug therapy; amiodarone or sotalol	Drug: Antiarrhythmic drug; Amiodarone or sotalol therapy; Other Names: Amiodarone, Sotalol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Hospital General Universitario Gregorio Marañon
• Investigators: Principal Investigator: Angel Arenal, MD, PhD, Hospital General Universitario Gregorio Maranon

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): September 29, 2017
• Study Completion (Actual): September 30, 2017

Study Registration Dates

• First Submitted: June 13, 2017
• First Submitted That Met QC Criteria: November 6, 2018
• First Posted (Actual): November 8, 2018

Study Record Updates

• Last Update Posted (Actual): March 15, 2019
• Last Update Submitted That Met QC Criteria: March 14, 2019
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Catheter Ablation; ICD; Ventricular tachycardia; Ischemic cardiomyopathy; Antiarrhythmic drug therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia; Tachycardia, Ventricular; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Membrane Transport Modulators; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Sodium Channel Blockers; Cytochrome P-450 CYP2D6 Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Sympatholytics; Potassium Channel Blockers; Amiodarone; Sotalol; Anti-Arrhythmia Agents
• Other Study ID Numbers: FIBHGM-0902

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED