A Phase 4 interventional study of Antiarrythmic Drug Therapy and Catheter ablation in Ventricular Tachycardia (VT), sponsored by John Sapp. Completed at 22 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-01.
Sponsored by John Sapp · Phase 4, Interventional, and Treatment
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.
623 studies on the registry are indexed under Tachycardia; 81 are open to participants now.
This study's enrollment of 416 is above the median of 64 across 379 interventional studies indexed under Tachycardia.
Browse Tachycardia studies →John Sapp is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Exclusion Criteria:
Catheter ablation of ventricular tachycardia
Procedure: Catheter ablation
Patients will be prescribed either oral amiodarone or sotalol daily (dosage and frequency to be determined based on patient's clinical presentation at the time of the qualifying arrhythmia).
Drug: Antiarrythmic Drug Therapy
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.)
Also known as: Amiodarone (Cordarone) or Sotalol (Sotacor)
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.
Also known as: VT ablation
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)
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)
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)
Plan to share: No
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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