Antiarrhythmics or Ablation for Ventricular Tachycardia 2

John Sapp416 enrolled

Overview

A multicenter, randomized clinical trial to assess whether catheter ablation or antiarrhythmic drug therapy provides the most effective control of important clinical outcomes for patients with prior myocardial infarction and sustained monomorphic ventricular tachycardia (VT).

Implantable Defibrillators (ICDs) reduce sudden death and can terminate some VT without shocks, but they don't prevent VT; the most appropriate strategy to suppress VT remains unknown. Two randomized clinical trials have suggested that catheter ablation can significantly reduce the incidence of subsequent VT in patients after an initial episode. Neither trial, however, compared catheter ablation to active antiarrhythmic drug therapy. Randomized trials of antiarrhythmic drug therapy have demonstrated that therapy with either sotalol or amiodarone can reduce recurrent VT. Both antiarrhythmic drug and ablation therapy suffer from imperfect efficacy and the potential for significant side-effects. No study has compared ablation to drug therapy for first-line treatment. The VANISH study which compared ablation to aggressive antiarrhythmic drug therapy for patients who have failed initial drug therapy was published in May 2016, and demonstrated that for patients with drug-refractory VT, catheter ablation was superior to escalation of antiarrhythmic drug therapy. Benefits were seen in the group which had VT despite amiodarone. Event rates were similar between amiodarone and sotalol for patients with VT occurring despite sotalol, who were randomized to either new initiation of amiodarone or catheter ablation. These results do not address the clinical question of the most appropriate first line therapy for suppression of VT in persons with prior myocardial infarction, an ICD and VT. The trial hypothesis is: catheter ablation will, in comparison to antiarrhythmic drug therapy reduce the composite outcome of death at any time, appropriate ICD shock after 14 days, ventricular tachycardia storm after 14 days or treated sustained ventricular tachycardia below the detection rate of the ICD for patients with prior myocardial infarction and sustained monomorphic ventricular tachycardia.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

416

Conditions

Ventricular Tachycardia (VT)

Interventions

Antiarrythmic Drug TherapyDRUG

Patients will be prescribed antiarrhythmic drugs (either amiodarone or sotalol based on specific clinical presentation, including medical history, functional class, ejection fraction, and renal function.)

Catheter ablationPROCEDURE

Intracardiac electrode catheters are placed via central vasculature to identify myocardial scar, and surviving conduction channels within the scar which form the substrate for ventricular tachycardia. Radiofrequency energy is applied to these sites, interrupting the VT circuits.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Prior Myocardial Infarction and * One of the following VT events while not being treated with amiodarone, sotalol, or another class I or class III antiarrhythmic drug) within the last 6 months: * Sustained monomorphic VT documented on 12-lead ECG or rhythm strip terminated by pharmacologic means or DC cardioversion * ≥3 episodes of VT treated with antitachycardia pacing (ATP), at least one of which was symptomatic * ≥ 5 episodes of VT treated with antitachycardia pacing (ATP) regardless of symptoms * ≥1 appropriate ICD shocks, * ≥3 VT episodes within 24 hours Exclusion Criteria: * Unable or unwilling to provide informed consent. * Active ischemia (acute thrombus diagnosed by coronary angiography, or dynamic ST segment changes demonstrated on ECG) or another reversible cause of VT (e.g. drug-induced arrhythmia), had recent acute coronary syndrome within 30 days, coronary revascularization (\<90 days bypass surgery, \<30 days percutaneous coronary intervention), or have CCS functional class IV angina. Note that biomarker level elevation alone after ventricular arrhythmias does not denote acute coronary syndrome or active ischemia. * Are ineligible to take the antiarrhythmic drug to which they would be assigned due to allergy, intolerance or contraindication * Are known to have protruding left ventricular thrombus or mechanical aortic and mitral valves * Have had a prior catheter ablation procedure for VT * Presenting arrhythmia: polymorphic VT or ventricular fibrillation (VF) * Are in renal failure (Creatinine clearance \<15 mL/min), have NYHA Functional class IV heart failure, or a systemic illness likely to limit survival to \<1 year * Have had recent ST elevation myocardial infarction or non-ST elevation MI (\< 30 days); note that biomarker elevation alone after ventricular arrhythmias does not denote MI. * Are pregnant.

Locations (22)

Hartford General Hospital

Hartford, Connecticut, United States

Outcomes

Primary Outcomes

All-cause mortality

Time to any death occurring at any time post randomization

Time frame: 8 years (including pilot study data)

Appropriate ICD shock at least 14 days post randomization

Time to first appropriate ICD shock after 14 days post randomization

Time frame: 8 years (including pilot study data)

VT storm at least 14 days post randomization

Time to 3 or more episodes of VT within 24 hours

Time frame: 8 years (including pilot study data)

Sustained VT requiring treatment at least 14 days post randomziation

Time to any sustained VT greater below the detection rate of the ICD requiring cardioversion (electrical or chemical) or manual ICD therapy at least 14 days post randomization

Time frame: 8 years (including pilot study data)

Secondary Outcomes

All-cause mortality at any time

Time to any death occurring at any time post randomization

Time frame: 8 years (including pilot study data)

Appropriate ICD ATP at any time or after 14 days

any appropriate therapy delivered from the ICD at least 14 days post randomization

Time frame: 8 years (including pilot study data)

Appropriate shocks at any time or after 14 days

appropriate ICD shocks at any time post randomization

Time frame: 8 years (including pilot study data)

Data from ClinicalTrials.gov

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Vanderbilt University Hospital

Nashville, Tennessee, United States

Foothills Hospital

Calgary, Alberta, Canada

University of Alberta Hospital

Edmonton, Alberta, Canada

Interior Health Authority

Kelowna, British Columbia, Canada

St. Paul's Hospital

Vancouver, British Columbia, Canada

Royal Jubilee Hospital

Victoria, British Columbia, Canada

Nova Scotia Health Authority

Halifax, Nova Scotia, Canada

Hamilton Health Sciences Center

Hamilton, Ontario, Canada

Queen's University Health Sciences Centre

Kingston, Ontario, Canada

...and 12 more locations

VT storm at any time or after 14 days

3 or more episodes of VT occurring within 24 hours at any time post randomization; including incessant VT

Time frame: 8 years (including pilot study data)

Sustained VT not treated by ICD at any time or after 14 days

any sustained VT greater than 30 seconds captured on a rhythm strip, monitor zone, holter monitor, or 12 lead ECG

Time frame: 8 years (including pilot study data)

Time to sustained VT treated with appropriate any type of manual cardioversion after 14 days

Any sustained VT greater than 30 seconds requiring manual cardioversion (ICD, external or pharmacologic)

Time frame: 8 years (including pilot study data)

Inappropriate ICD shocks at any time or after 14 days

all inappropriate shocks from the ICD at any time post randomization

Time frame: 8 years (including pilot study data)

Any ICD shock at any time or after 14 days

Both appropriate and inappropriate shocks from the ICD at any time post randomization

Time frame: 6 years (including pilot study data)

Any ventricular arrhythmia event at any time or after 14 days (composite of appropriate ATP, appropriate shock, sustained VT not treated by ICD, external cardioversion, or pharmacologic cardioversion)

All ventricular arrhythmias including a composite of: appropriate ATP, appropriate shock, sustained VT not treated by ICD, external cardioversion, or pharmacologic cardioversion), VT storm/incessant VT.

Time frame: 8 years (including pilot study data)

Number of ICD shocks (all cause)

the number of all shocks from any cause will be calculated

Time frame: 8 years (including pilot study data)

Number of Anti-tachycardia pacing (ATP)

The total of all ATP delivered from the ICD will be calculated

Time frame: 8 years (including pilot study data)

Number of ICD appropriate therapy

Total number of therapies which received appropriate ICD therapy

Time frame: 8 years (including pilot study data)

Number of VT storm events

Total number of VT storms (3 episodes of VT within 24 hours)/ incessant VT will be calculated

Time frame: 8 years (including pilot study data)

Number of sustained VT events

Total number of sustained VT (greater than 30 seconds)

Time frame: 8 years (including pilot study data)

Number of ventricular arrhythmia events

This is a composite of appropriate ATP, appropriate shock, sustained VT not treated by ICD, external cardioversion, or pharmacologic cardioversion, or VT storm/incessant VT. VT events which do not terminate despite exhausting ICD therapies will be considered incessant VT and included within the definition of VT storm.

Time frame: 8 years (including pilot study data)

Hospital admission for cardiac causes

Hospitalizations greater than 24 hours due to a cardiovascular cause.

Time frame: 8 years (including pilot study data)

Ablation procedural complications or antiarrhythmic drug adverse effects (this may require a separate substudy, depending on data complexity)

Periprocedural complications and adverse drug reactions will be assessed

Time frame: 8 years (including pilot study data)

Serious adverse events

Serious events is any event which causes death, hospitalization, is life threatening and is directly related to the study treatment.

Time frame: 8 years (including pilot study data)

Side effects from anti-arrhythmic medication

Any dose change or discontinuation of anti-arrhythmic medication due to abnormal blood tests (including kidney function, liver function, thyroid function) or any perceived side effects.

Time frame: 8 years (including pilot study data)

Quality of life - SF36

Will include responses from the Short Form 36

Time frame: 8 years (including pilot study data)

Quality of life - EQ5D

Will include responses from the Euroquol 5D questionnaire

Time frame: 8 years (including pilot study data))

Quality of life - HADS

Will include responses from the Hospital Anxiety and Depression Scale quesionnaire

Time frame: 8 years (including pilot study data)

Cost-effectiveness

Quality adjusted life years (QALYs) will be derived from the case report forms and the questionnaires

Time frame: 8 years (including pilot study data)

Escalation and De-escalation of antiarrhythmic medication

Any increase or decrease in the dosage of antiarrhythmic medication either due to inefficacy or side effects will be assessed.

Time frame: 8 years (including pilot study data)

ICD Revision

Surgical revisions to implanted defibrillators at any time

Time frame: 8 years (including pilot study data)