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| Name | Class |
|---|---|
| Heart and Stroke Foundation of Canada | OTHER |
| Abbott Medical Devices | INDUSTRY |
| Biosense Webster, Inc. | INDUSTRY |
| Ottawa Heart Institute Research Corporation |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VT catheter ablation | Active Comparator | Catheter ablation of ventricular tachycardia |
|
| Antiarrhythmic Drug Therapy | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antiarrythmic Drug Therapy | Drug | 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.) |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | Time to any death occurring at any time post randomization | 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 | 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 | 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 | 8 years (including pilot study data) |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality at any time | Time to any death occurring at any time post randomization | 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 |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John L Sapp, MD FRCPC | Nova Scotia Health Authority | Principal Investigator |
| Ratika Parkash, MD MSc FRCPC | Nova Scotia Health Authoriry | Study Director |
| Anthony L Tang, MD FRCPC | London Health Sciences Centre | Study Director |
| George A Wells, BSc MSc PhD | Ottawa Heart Institute Research Corporation | Study Director |
| William G Stevenson, MD | Brigham and Women's Hospital | Study Director |
| Jeff Healey, MD FRCPC | Population Health Research Institute, McMaster University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hartford General Hospital | Hartford | Connecticut | 06102 | United States | ||
| Vanderbilt University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41217320 | Derived | Nery PB, Wells GA, Tang ASL, Parkash R, Stevenson W, Healey JS, Gula L, Nair GM, Essebag V, Rivard L, Deyell MW, Sarrazin JF, Amit G, Roux JF, AbdelWahab A, Lane C, Samuel M, Sandila N, Sapp JL; VANISH2 Study Team. Catheter Ablation vs Sotalol or Amiodarone for Ventricular Tachycardia: A Substudy of the VANISH2 Trial. J Am Coll Cardiol. 2026 Jan 20;87(2):157-168. doi: 10.1016/j.jacc.2025.09.1595. Epub 2025 Oct 11. | |
| 39555820 |
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| OTHER |
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| Cardiac Arrhythmia Network of Canada | OTHER |
| Abbott | INDUSTRY |
| Nova Scotia Health Authority | OTHER |
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| Catheter ablation | Procedure | 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. |
|
|
| 8 years (including pilot study data) |
| Appropriate shocks at any time or after 14 days | appropriate ICD shocks at any time post randomization | 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 | 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 | 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) | 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 | 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 | 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. | 8 years (including pilot study data) |
| Number of ICD shocks (all cause) | the number of all shocks from any cause will be calculated | 8 years (including pilot study data) |
| Number of Anti-tachycardia pacing (ATP) | The total of all ATP delivered from the ICD will be calculated | 8 years (including pilot study data) |
| Number of ICD appropriate therapy | Total number of therapies which received appropriate ICD therapy | 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 | 8 years (including pilot study data) |
| Number of sustained VT events | Total number of sustained VT (greater than 30 seconds) | 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. | 8 years (including pilot study data) |
| Hospital admission for cardiac causes | Hospitalizations greater than 24 hours due to a cardiovascular cause. | 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 | 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. | 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. | 8 years (including pilot study data) |
| Quality of life - SF36 | Will include responses from the Short Form 36 | 8 years (including pilot study data) |
| Quality of life - EQ5D | Will include responses from the Euroquol 5D questionnaire | 8 years (including pilot study data)) |
| Quality of life - HADS | Will include responses from the Hospital Anxiety and Depression Scale quesionnaire | 8 years (including pilot study data) |
| Cost-effectiveness | Quality adjusted life years (QALYs) will be derived from the case report forms and the questionnaires | 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. | 8 years (including pilot study data) |
| ICD Revision | Surgical revisions to implanted defibrillators at any time | 8 years (including pilot study data) |
| Nashville |
| Tennessee |
| 37232 |
| United States |
| Foothills Hospital | Calgary | Alberta | T2W 1S7 | Canada |
| University of Alberta Hospital | Edmonton | Alberta | T6G 2B7 | Canada |
| Interior Health Authority | Kelowna | British Columbia | V1Y 1T2 | Canada |
| St. Paul's Hospital | Vancouver | British Columbia | V6E 1M7 | Canada |
| Royal Jubilee Hospital | Victoria | British Columbia | V8R 1J8 | Canada |
| Nova Scotia Health Authority | Halifax | Nova Scotia | B3H 3A7 | Canada |
| Hamilton Health Sciences Center | Hamilton | Ontario | L8L 8E7 | Canada |
| Queen's University Health Sciences Centre | Kingston | Ontario | K7L 2V7 | Canada |
| St. Mary's Hospital | Kitchener | Ontario | N2M 1B2 | Canada |
| London Health Sciences Centre | London | Ontario | N6A 5A5 | Canada |
| University of Ottawa Heart Institute | Ottawa | Ontario | K1Y 4W7 | Canada |
| St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| Montreal Heart Institute | Montreal | Quebec | H1T 1C8 | Canada |
| Centre Hospitalier de l'Universitaire de Montreal | Montreal | Quebec | H2X 0A9 | Canada |
| McGill University Health Center | Montreal | Quebec | H3H 1A4 | Canada |
| Sacre-Coeur Hospital | Montreal | Quebec | H4J 1C5 | Canada |
| Institut Universitaire de cardiologie et pneumologie de Quebec - Laval University Hosptial | Québec | Quebec | G1V 4G5 | Canada |
| Centre Hospitalier Universitaire de Sherbrooke | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Hopitaux de Bordeaux | Bordeaux | Acquitaine | 33604 | France |
| CHU - University Hospital Nancy | Nancy | Meurthe-et-Moselle | 54511 | France |
| Derived |
| Sapp JL, Tang ASL, Parkash R, Stevenson WG, Healey JS, Gula LJ, Nair GM, Essebag V, Rivard L, Roux JF, Nery PB, Sarrazin JF, Amit G, Raymond JM, Deyell M, Lane C, Sacher F, de Chillou C, Kuriachan V, AbdelWahab A, Nault I, Dyrda K, Wilton S, Jolly U, Kanagasundram A, Wells GA; VANISH2 Study Team. Catheter Ablation or Antiarrhythmic Drugs for Ventricular Tachycardia. N Engl J Med. 2025 Feb 20;392(8):737-747. doi: 10.1056/NEJMoa2409501. Epub 2024 Nov 16. |
| 38649085 | Derived | Sapp JL, Tang ASL, Parkash R, Stevenson WG, Healey JS, Wells G. A randomized clinical trial of catheter ablation and antiarrhythmic drug therapy for suppression of ventricular tachycardia in ischemic cardiomyopathy: The VANISH2 trial. Am Heart J. 2024 Aug;274:1-10. doi: 10.1016/j.ahj.2024.04.009. Epub 2024 Apr 21. |
| 31698933 | Derived | Kheiri B, Barbarawi M, Zayed Y, Hicks M, Osman M, Rashdan L, Kyi HH, Bachuwa G, Hassan M, Stecker EC, Nazer B, Bhatt DL. Antiarrhythmic Drugs or Catheter Ablation in the Management of Ventricular Tachyarrhythmias in Patients With Implantable Cardioverter-Defibrillators: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Circ Arrhythm Electrophysiol. 2019 Nov;12(11):e007600. doi: 10.1161/CIRCEP.119.007600. Epub 2019 Nov 8. |
| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000638 | Amiodarone |
| D013015 | Sotalol |
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| 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 |
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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