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Antiarrhythmics or Ablation for Ventricular Tachycardia 2 (VANISH2)

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ClinicalTrials.gov Identifier: NCT02830360
Recruitment Status : Recruiting
First Posted : July 12, 2016
Last Update Posted : April 25, 2019
Sponsor:
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
Information provided by (Responsible Party):
John Sapp, Nova Scotia Health Authority

Brief 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).

Condition or disease Intervention/treatment Phase
Ventricular Tachycardia (VT) Drug: Antiarrythmic Drug Therapy Procedure: Catheter ablation Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 366 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ventricular Tachycardia Antiarrhythmics or AblatioN In Structural Heart Disease 2
Actual Study Start Date : October 2016
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2022


Arm Intervention/treatment
Active Comparator: VT catheter ablation
Catheter ablation of ventricular tachycardia
Procedure: Catheter 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.
Other Name: VT ablation

Active Comparator: Antiarrhythmic Drug Therapy
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.)
Other Name: Amiodarone (Cordarone) or Sotalol (Sotacor)




Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 6 years (including pilot study data) ]
    Time to any death occurring at any time post randomization

  2. Appropriate ICD shock at least 14 days post randomization [ Time Frame: 6 years (including pilot study data) ]
    Time to first appropriate ICD shock after 14 days post randomization

  3. VT storm at least 14 days post randomization [ Time Frame: 6 years ]
    Time to 3 or more episodes of VT within 24 hours

  4. Sustained VT requiring treatment at least 14 days post randomziation [ Time Frame: 6 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

  5. Incessant VT at least 14 days post randomization [ Time Frame: 6 years (including pilot study data) ]
    Time to incessant VT at least 14 days post randomization


Secondary Outcome Measures :
  1. Appropriate ICD ATP at any time or after 14 days [ Time Frame: 6 years (including pilot study data) ]
    any appropriate therapy delivered from the ICD at least 14 days post randomization

  2. Appropriate shocks [ Time Frame: 6 years (including pilot study data) ]
    appropriate ICD shocks at any time post randomization

  3. VT storm at any time or after 14 days [ Time Frame: 6 years (including pilot study data) ]
    3 or more episodes of VT occurring within 24 hours at any time post randomization

  4. Sustained VT not treated by ICD at any time or after 14 days [ Time Frame: 6 years (including pilot study data) ]
    any sustained VT greater than 30 seconds captured on a rhythm strip, monitor zone, holter monitor, or 12 lead ECG

  5. Incessant VT at any time or after 14 days [ Time Frame: 6 years (including pilot study data) ]
  6. Time to sustained VT treated with appropriate any type of manual cardioversion after 14 days [ Time Frame: 6 years (including pilot study data) ]
    Any sustained VT greater than 30 seconds requiring manual cardioversion (ICD, external or pharmacologic)

  7. Inappropriate ICD shocks at any time or after 14 days [ Time Frame: 6 years (including pilot study data) ]
    all inappropriate shocks from the ICD at any time post randomization

  8. Any ICD shock at any time or after 14 days [ Time Frame: 6 years (including pilot study data) ]
    Both appropriate and inappropriate shocks from the ICD at any time post randomization

  9. 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: 6 years (including pilot study data) ]
    All ventricular arrhythmias including a composite of: appropriate ATP, appropriate shock, sustained VT not treated by ICD, external cardioversion, or pharmacologic cardioversion)

  10. Number of ICD shocks (all cause) [ Time Frame: 6 years (including pilot study data) ]
    the number of all shocks from any cause will be calculated

  11. Number of Anti-tachycardia pacing (ATP) [ Time Frame: 6 years (including pilot study data) ]
    The total of all ATP delivered from the ICD will be calculated

  12. Number of ICD appropriate therapy [ Time Frame: 6 years (including pilot study data) ]
    Total number of therapies which received appropriate ICD therapy

  13. Number of VT storm events [ Time Frame: 6 years (including pilot study data) ]
    Total number of VT storms (3 episodes of VT within 24 hours) will be calculated

  14. Number of sustained VT events [ Time Frame: 6 years (including pilot study data) ]
    Total number of sustained VT (greater than 30 seconds)

  15. Number of ventricular arrhythmia events [ Time Frame: 6 years (including pilot study data) ]
    This is a composite of appropriate ATP, appropriate shock, sustained VT not treated by ICD, external cardioversion, or pharmacologic cardioversion, and incessant VT

  16. Hospital admission for cardiac causes [ Time Frame: 6 years (including pilot study data) ]
    Hospitalizations greater than 24 hours due to a cardiovascular cause.

  17. .Ablation procedural complications or antiarrhythmic drug adverse effects (this may require a separate substudy, depending on data complexity) [ Time Frame: 6 years (including pilot study data) ]
    Periprocedural complications and adverse drug reactions will be assessed

  18. Time to any serious adverse events [ Time Frame: 6 years (including pilot study data) ]
    Serious events is any event which causes death, hospitalization, is life threatening and is directly related to the study treatment.

  19. Side effects from anti-arrhythmic medication [ Time Frame: 6 years (including pilot study data) ]
    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.

  20. Quality of life - SF36 [ Time Frame: 6 years (including pilot study data) ]
    Will include responses from the Short Form 36

  21. Quality of life - EQ5D [ Time Frame: 6 years (including pilot study data) ]
    Will include responses from the Euroquol 5D questionnaire

  22. Quality of life - HADS [ Time Frame: 6 years (including pilot study data) ]
    Will include responses from the Hospital Anxiety and Depression Scale quesionnaire

  23. Cost-effectiveness [ Time Frame: 6 years (including pilot study data) ]
    Quality adjusted life years (QALYs) will be derived from the case report forms and the questionnaires

  24. Escalation and De-escalation of antiarrhythmic medication [ Time Frame: 6 years (including pilot study data) ]
    Any increase or decrease in the dosage of antiarrhythmic medication either due to inefficacy or side effects will be assessed.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830360


Contacts
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Contact: Karen A Giddens, RDMS RDCS 9024732758 karen.giddens@nshealth.ca
Contact: John L Sapp, MD FRCPC 902 473 4272 john.sapp@nshealth.ca

Locations
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United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102
Contact: Lizabeth Roper, MHS         
Principal Investigator: Edmond Cronin, MD         
United States, Tennessee
Vanderbilt University Hospital Recruiting
Nashville, Tennessee, United States, 37232
Contact: Libby Salberg    615-322-2281    libby.salberg@vumc.org   
Principal Investigator: Arvindh Kanagasundram, MD         
Canada, Alberta
Foothills Hospital Recruiting
Calgary, Alberta, Canada, T2W 1S7
Contact: Marcello Tonelli, Dr         
Principal Investigator: Vikas Kuriachan, MD, FRCPC         
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Ronald Welch    780-407-8007    Ron.Welch@albertahealthservices.ca   
Principal Investigator: Tomasz Hrusczkowski, MD, FRCPC         
Canada, British Columbia
Fraser Health Authority - Royal Columbian Hospital Recruiting
Vancouver, British Columbia, Canada, V3T OH1
Contact: Susan Chunick    604-587-4681    susan.chunick@fraserhealth.ca   
Principal Investigator: Stan Tung, MD, FRCPC         
St. Paul's Hospital Recruiting
Vancouver, British Columbia, Canada, V6E 1M7
Contact: S.F. Paul Man, MD, FRCPC    (604) 806-8495    pman@providencehealth.bc.ca   
Principal Investigator: Marc Deyell, MD, FRCPC         
Royal Jubilee Hospital Recruiting
Victoria, British Columbia, Canada, V8R 1J8
Contact: Cindy Trytten    250-370-8485    Cindy.Trytten@viha.ca   
Principal Investigator: Chris Lane, MD, FRCPC         
Canada, Nova Scotia
Nova Scotia Health Authority Recruiting
Halifax, Nova Scotia, Canada, B3H 3A7
Contact: Karen Giddens    902 473 2758    karen.giddens@nshealth.ca   
Principal Investigator: John L Sapp, MD FRCPC         
Canada, Ontario
Hamilton Health Sciences Center Recruiting
Hamilton, Ontario, Canada, L8L 8E7
Contact: Ted Scott, PhD    905.521.2100 ext. 72290    scottted@HHSC.CA   
Principal Investigator: Guy Amit, MD, MPH         
Queen's University Health Sciences Centre Recruiting
Kingston, Ontario, Canada, K7L 2V7
Contact: Roger Deeley, PhD    613-549-6666 x.3344    Roger.Deeley@Kingstonhsc.ca   
Principal Investigator: Damian Redfearn, MD, FRCPC         
St. Mary's Hospital Recruiting
Kitchener, Ontario, Canada, N2M 1B2
Contact: Marco Terlevic         
Principal Investigator: Umjeet Jolly, MD, FRCPC         
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5A5
Contact: Cheryl Litchfield       cheryl.litchfield@lawsonresearch.com   
Principal Investigator: Lorne Gula, MD, FRCPC         
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Contact: Marion Fraser, CA, MBA         
Principal Investigator: Pablo nery, ZMD, FRCPC         
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Arthur Slutsky, MD    416 864-5637    SlutskyA@smh.ca   
Principal Investigator: Paul Angaran, MD, FRCPC         
Canada, Quebec
Montreal Heart Institute Recruiting
Montreal, Quebec, Canada, H1T 1C8
Contact: Gilles Lefebvre         
Principal Investigator: Lena Rivard, MD, FRCPC         
McGill University Health Center Recruiting
Montreal, Quebec, Canada, H3H 1A4
Contact: Costas N Karatzas, MSc, PhD    514-934-1934 ext. 71532    costas.karatzas@mail.mcgill.ca   
Principal Investigator: Vidal Essebag, MD, FRCPC         
Centre Hospitalier de l'Universitaire de Montreal Recruiting
Montréal, Quebec, Canada, H2X 0A9
Contact: Vincent Poitout, DVM, PhD, FCAHS    514 890-8044    vincent.poitout@umontreal.ca   
Principal Investigator: Jean-Marc Raymond, MD, FRCPC         
Institut Universitaire de cardiologie et pneumologie de Quebec - Laval University Hosptial Recruiting
Quebec CIty, Quebec, Canada, G1V 4G5
Contact: Michele Clavet         
Principal Investigator: Jean-Francois Sarazzin, MD, FRCPC         
Centre Hospitalier Univesitaire de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Sylvain Bernier, MAP, PhD         
Principal Investigator: Jean-Francois Roux, Md, FRCPC         
France
Hopitaux de Bordeaux Not yet recruiting
Bordeaux, Acquitaine, France, 33604
Contact: Phillippe Vigouroux         
Principal Investigator: Fred Sacher, MD         
CHU - University Hospital Nancy Not yet recruiting
Nancy, Meurthe-et-Moselle, France, 54511
Contact: Philippe Vigouroux         
Principal Investigator: Christian De Chillou, MD         
Sponsors and Collaborators
John Sapp
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
Investigators
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Principal Investigator: John L Sapp, MD FRCPC Nova Scotia Health Authority
Study Director: 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

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Responsible Party: John Sapp, Staff Physician, Division of Cardiology, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT02830360     History of Changes
Other Study ID Numbers: SAPP004
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by John Sapp, Nova Scotia Health Authority:
Antiarrhythmic drug therapy
VT Catheter ablation
ICD Therapy
Ischemic Heart Disease
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Pathologic Processes
Amiodarone
Sotalol
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents