Ventricular Tachycardia (VT)Phase 4VANISH2NCT02830360
Antiarrhythmics or Ablation for Ventricular Tachycardia 2
A Phase 4 study testing Antiarrythmic Drug Therapy and Catheter ablation in people with Ventricular Tachycardia (VT), run by John Sapp at 22 sites in 3 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia (VT)
- What is being tested?
- Antiarrythmic Drug Therapy and Catheter ablation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 22 sitesin 3 countries
- Study dates
- Oct 2016to 30 Jun 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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.
Trial locations and contacts
22 sites in 3 countries.
22 sites in 3 countries
Canada18 sites
Foothills Hospital
Calgary, Alberta, T2W 1S7
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 3A7
Hamilton Health Sciences Center
Hamilton, Ontario, L8L 8E7
Interior Health Authority
Kelowna, British Columbia, V1Y 1T2
Queen's University Health Sciences Centre
Kingston, Ontario, K7L 2V7
St. Mary's Hospital
Kitchener, Ontario, N2M 1B2
London Health Sciences Centre
London, Ontario, N6A 5A5
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Centre Hospitalier de l'Universitaire de Montreal
Montreal, Quebec, H2X 0A9
McGill University Health Center
Montreal, Quebec, H3H 1A4
Sacre-Coeur Hospital
Montreal, Quebec, H4J 1C5
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Institut Universitaire de cardiologie et pneumologie de Quebec - Laval University Hosptial
Québec, Quebec, G1V 4G5
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
St. Paul's Hospital
Vancouver, British Columbia, V6E 1M7
Royal Jubilee Hospital
Victoria, British Columbia, V8R 1J8
United States2 sites
Hartford General Hospital
Hartford, Connecticut, 06102
Vanderbilt University Hospital
Nashville, Tennessee, 37232
France2 sites
Hopitaux de Bordeaux
Bordeaux, Acquitaine, 33604
CHU - University Hospital Nancy
Nancy, Meurthe-et-Moselle, 54511
About this study
Official title: Ventricular Tachycardia Antiarrhythmics or AblatioN In Structural Heart Disease 2
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).
Read the detailed description
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.
- Conditions
- Ventricular Tachycardia (VT)
- Being tested
- Antiarrythmic Drug Therapy, Catheter ablation
- Keywords
- Antiarrhythmic drug therapy, VT Catheter ablation, ICD Therapy, Ischemic Heart Disease
- Medical subject headings
- Tachycardia, Ventricular, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antiarrythmic Drug TherapyDrug
Also called Amiodarone (Cordarone) or Sotalol (Sotacor)
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 or surgery
Also called VT ablation
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.
| Study group | Role | What they receive |
|---|---|---|
| VT catheter ablation | Active comparator | Catheter ablation of ventricular tachycardia Receives: Procedure: Catheter ablation |
| 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). Receives: Drug: Antiarrythmic Drug Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Time to any death occurring at any time post randomization
Measured: 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
Measured: 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
Measured: 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
Measured: 8 years (including pilot study data)
Secondary outcomes (25)
All-cause mortality at any time
Time to any death occurring at any time post randomization
Measured: 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
Measured: 8 years (including pilot study data)
Appropriate shocks at any time or after 14 days
appropriate ICD shocks at any time post randomization
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: 8 years (including pilot study data)
Number of ICD shocks (all cause)
the number of all shocks from any cause will be calculated
Measured: 8 years (including pilot study data)
Number of Anti-tachycardia pacing (ATP)
The total of all ATP delivered from the ICD will be calculated
Measured: 8 years (including pilot study data)
Number of ICD appropriate therapy
Total number of therapies which received appropriate ICD therapy
Measured: 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
Measured: 8 years (including pilot study data)
Number of sustained VT events
Total number of sustained VT (greater than 30 seconds)
Measured: 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.
Measured: 8 years (including pilot study data)
Hospital admission for cardiac causes
Hospitalizations greater than 24 hours due to a cardiovascular cause.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 8 years (including pilot study data)
Quality of life - SF36
Will include responses from the Short Form 36
Measured: 8 years (including pilot study data)
Quality of life - EQ5D
Will include responses from the Euroquol 5D questionnaire
Measured: 8 years (including pilot study data))
Quality of life - HADS
Will include responses from the Hospital Anxiety and Depression Scale quesionnaire
Measured: 8 years (including pilot study data)
Cost-effectiveness
Quality adjusted life years (QALYs) will be derived from the case report forms and the questionnaires
Measured: 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.
Measured: 8 years (including pilot study data)
ICD Revision
Surgical revisions to implanted defibrillators at any time
Measured: 8 years (including pilot study data)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study startOct 2016
- Primary completion6 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ventricular Tachycardia (VT)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- John Sapp
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, Abbott Medical Devices, Biosense Webster, Inc., Ottawa Heart Institute Research Corporation, Canadian Institutes of Health Research (CIHR), Cardiac Arrhythmia Network of Canada, Abbott, Nova Scotia Health Authority
- Responsible party
- Sponsor-investigator, John Sapp, Nova Scotia Health Authority
- Investigators
- John L Sapp, MD FRCPC, Principal investigator, Nova Scotia Health AuthorityRatika Parkash, MD MSc FRCPC, Study director, Nova Scotia Health AuthoriryAnthony L Tang, MD FRCPC, Study director, London Health Sciences CentreGeorge A Wells, BSc MSc PhD, Study director, Ottawa Heart Institute Research CorporationWilliam G Stevenson, MD, Study director, Brigham and Women's HospitalJeff Healey, MD FRCPC, Study director, Population Health Research Institute, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02830360
- Sponsor's protocol ID
- SAPP004
- Acronym
- VANISH2
- Status last verified
- Jul 2024
- First submitted
- 7 Jul 2016
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 41217320Sapp 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.
PubMed 39555820Sapp 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.
PubMed 38649085Kheiri 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.
PubMed 31698933
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventricular Tachycardia Antiarrhythmics or AblatioN In Structural Heart Disease 2
- ClinicalTrials.gov ID
- NCT02830360
- Acronym / sponsor ID
- VANISH2 / SAPP004
- Conditions
- Ventricular Tachycardia (VT)
- Keywords
- Antiarrhythmic drug therapy, VT Catheter ablation, ICD Therapy, Ischemic Heart Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- John SappUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, Abbott Medical Devices, Biosense Webster, Inc., Ottawa Heart Institute Research Corporation, Canadian Institutes of Health Research (CIHR), Cardiac Arrhythmia Network of Canada, Abbott, Nova Scotia Health Authority
- Study start
- Oct 2016 (actual)
- Primary completion
- 6 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 12 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VT catheter ablation | Active comparator | Procedure: Catheter ablationCatheter ablation of ventricular tachycardia |
| Antiarrhythmic Drug Therapy | Active comparator | Drug: Antiarrythmic Drug TherapyPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antiarrythmic Drug TherapyAlso: Amiodarone (Cordarone) or Sotalol (Sotacor)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.) | Drug | Antiarrhythmic Drug Therapy |
| Catheter ablationAlso: VT ablationIntracardiac 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. | Procedure or surgery | VT catheter ablation |
Primary outcome
All-cause mortality
Time frame: 8 years (including pilot study data)
Time to any death occurring at any time post randomization
Appropriate ICD shock at least 14 days post randomization
Time frame: 8 years (including pilot study data)
Time to first appropriate ICD shock after 14 days post randomization
VT storm at least 14 days post randomization
Time frame: 8 years (including pilot study data)
Time to 3 or more episodes of VT within 24 hours
Sustained VT requiring treatment at least 14 days post randomziation
Time frame: 8 years (including pilot study data)
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
25 secondary outcomes
All-cause mortality at any time
Time frame: 8 years (including pilot study data)
Appropriate ICD ATP at any time or after 14 days
Time frame: 8 years (including pilot study data)
Appropriate shocks at any time or after 14 days
Time frame: 8 years (including pilot study data)
VT storm at any time or after 14 days
Time frame: 8 years (including pilot study data)
Sustained VT not treated by ICD at any time or after 14 days
Time frame: 8 years (including pilot study data)
Time to sustained VT treated with appropriate any type of manual cardioversion after 14 days
Time frame: 8 years (including pilot study data)
Inappropriate ICD shocks at any time or after 14 days
Time frame: 8 years (including pilot study data)
Any ICD shock at any time or after 14 days
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)
Time frame: 8 years (including pilot study data)
Number of ICD shocks (all cause)
Time frame: 8 years (including pilot study data)
Number of Anti-tachycardia pacing (ATP)
Time frame: 8 years (including pilot study data)
Number of ICD appropriate therapy
Time frame: 8 years (including pilot study data)
Number of VT storm events
Time frame: 8 years (including pilot study data)
Number of sustained VT events
Time frame: 8 years (including pilot study data)
Number of ventricular arrhythmia events
Time frame: 8 years (including pilot study data)
Hospital admission for cardiac causes
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)
Time frame: 8 years (including pilot study data)
Serious adverse events
Time frame: 8 years (including pilot study data)
Side effects from anti-arrhythmic medication
Time frame: 8 years (including pilot study data)
Quality of life - SF36
Time frame: 8 years (including pilot study data)
Quality of life - EQ5D
Time frame: 8 years (including pilot study data))
Quality of life - HADS
Time frame: 8 years (including pilot study data)
Cost-effectiveness
Time frame: 8 years (including pilot study data)
Escalation and De-escalation of antiarrhythmic medication
Time frame: 8 years (including pilot study data)
ICD Revision
Time frame: 8 years (including pilot study data)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Derived from this study: PubMed 41217320Nery 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.
- Derived from this study: PubMed 39555820Sapp 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.
- Derived from this study: PubMed 38649085Sapp 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.
- Derived from this study: PubMed 31698933Kheiri 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John L Sapp, MD FRCPC principal investigator
Nova Scotia Health Authority
Ratika Parkash, MD MSc FRCPC study director
Nova Scotia Health Authoriry
Anthony L Tang, MD FRCPC study director
London Health Sciences Centre
22 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Antiarrythmic Drug Therapy and Catheter ablation in people with Ventricular Tachycardia (VT), run by John Sapp at 22 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Canada, United States, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 8 years (including pilot study data)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02830360, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.