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Antiarrhythmics or Ablation for Ventricular Tachycardia 2 (VANISH2)

Primary Purpose

Ventricular Tachycardia (VT)

Status

Active

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Antiarrythmic Drug Therapy

Catheter ablation

About this trial

This is an interventional treatment trial for Ventricular Tachycardia (VT) focused on measuring Antiarrhythmic drug therapy, VT Catheter ablation, ICD Therapy, Ischemic Heart Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Vanderbilt University Hospital
Foothills Hospital
University of Alberta Hospital
Interior Health Authority
Fraser Health Authority - Royal Columbian Hospital
St. Paul's Hospital
Royal Jubilee Hospital
Nova Scotia Health Authority
Hamilton Health Sciences Center
Queen's University Health Sciences Centre
St. Mary's Hospital
London Health Sciences Centre
University of Ottawa Heart Institute
St. Michael's Hospital
Montreal Heart Institute
McGill University Health Center
Centre Hospitalier de l'Universitaire de Montreal
Institut Universitaire de cardiologie et pneumologie de Quebec - Laval University Hosptial
Centre Hospitalier Univesitaire de Sherbrooke
Hopitaux de Bordeaux
CHU - University Hospital Nancy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

VT catheter ablation

Antiarrhythmic Drug Therapy

Arm Description

Catheter ablation of ventricular tachycardia

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).

Outcomes

Primary Outcome Measures

All-cause mortality

Time to any death occurring at any time post randomization

Appropriate ICD shock at least 14 days post randomization

Time to first appropriate ICD shock after 14 days post randomization

VT storm at least 14 days post randomization

Time to 3 or more episodes of VT within 24 hours

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

Secondary Outcome Measures

All-cause mortality at any time

Time to any death occurring at any time post randomization

Appropriate ICD ATP at any time or after 14 days

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

Appropriate shocks

appropriate ICD shocks at any time post randomization

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

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 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)

Inappropriate ICD shocks at any time or after 14 days

all inappropriate shocks from the ICD at any time post randomization

Any ICD shock at any time or after 14 days

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

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.

Number of ICD shocks (all cause)

the number of all shocks from any cause will be calculated

Number of Anti-tachycardia pacing (ATP)

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

Number of ICD appropriate therapy

Total number of therapies which received appropriate ICD therapy

Number of VT storm events

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

Number of sustained VT events

Total number of sustained VT (greater than 30 seconds)

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.

Hospital admission for cardiac causes

Hospitalizations greater than 24 hours due to a cardiovascular cause.

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 to any serious adverse events

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

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.

Quality of life - SF36

Will include responses from the Short Form 36

Quality of life - EQ5D

Will include responses from the Euroquol 5D questionnaire

Quality of life - HADS

Will include responses from the Hospital Anxiety and Depression Scale quesionnaire

Cost-effectiveness

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

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.

Full Information

NCT ID

NCT02830360

First Posted

July 7, 2016

Last Updated

August 30, 2023

Sponsor

John Sapp

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

1. Study Identification

Unique Protocol Identification Number

NCT02830360

Brief Title

Antiarrhythmics or Ablation for Ventricular Tachycardia 2

Acronym

VANISH2

Official Title

Ventricular Tachycardia Antiarrhythmics or AblatioN In Structural Heart Disease 2

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 2016 (Actual)

Primary Completion Date

June 6, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

John Sapp

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ventricular Tachycardia (VT)

Keywords

Antiarrhythmic drug therapy, VT Catheter ablation, ICD Therapy, Ischemic Heart Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

416 (Actual)

8. Arms, Groups, and Interventions

Arm Title

VT catheter ablation

Arm Type

Active Comparator

Arm Description

Catheter ablation of ventricular tachycardia

Arm Title

Antiarrhythmic Drug Therapy

Arm Type

Active Comparator

Arm Description

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).

Intervention Type

Drug

Intervention Name(s)

Antiarrythmic Drug Therapy

Other Intervention Name(s)

Amiodarone (Cordarone) or Sotalol (Sotacor)

Intervention Description

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.)

Intervention Type

Procedure

Intervention Name(s)

Catheter ablation

Other Intervention Name(s)

VT ablation

Intervention Description

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.

Primary Outcome Measure Information:

Title

All-cause mortality

Description

Time to any death occurring at any time post randomization

Time Frame

8 years (including pilot study data)

Title

Appropriate ICD shock at least 14 days post randomization

Description

Time to first appropriate ICD shock after 14 days post randomization

Time Frame

8 years (including pilot study data)

Title

VT storm at least 14 days post randomization

Description

Time to 3 or more episodes of VT within 24 hours

Time Frame

8 years (including pilot study data)

Title

Sustained VT requiring treatment at least 14 days post randomziation

Description

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 Outcome Measure Information:

Title

All-cause mortality at any time

Description

Time to any death occurring at any time post randomization

Time Frame

8 years (including pilot study data)

Title

Appropriate ICD ATP at any time or after 14 days

Description

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

Time Frame

8 years (including pilot study data)

Title

Appropriate shocks

Description

appropriate ICD shocks at any time post randomization

Time Frame

8 years (including pilot study data)

Title

VT storm at any time or after 14 days

Description

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)

Title

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

Description

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)

Title

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

Description

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

Time Frame

8 years (including pilot study data)

Title

Inappropriate ICD shocks at any time or after 14 days

Description

all inappropriate shocks from the ICD at any time post randomization

Time Frame

8 years (including pilot study data)

Title

Any ICD shock at any time or after 14 days

Description

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

Time Frame

6 years (including pilot study data)

Title

Description

Time Frame

8 years (including pilot study data)

Title

Number of ICD shocks (all cause)

Description

the number of all shocks from any cause will be calculated

Time Frame

8 years (including pilot study data)

Title

Number of Anti-tachycardia pacing (ATP)

Description

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

Time Frame

8 years (including pilot study data)

Title

Number of ICD appropriate therapy

Description

Total number of therapies which received appropriate ICD therapy

Time Frame

8 years (including pilot study data)

Title

Number of VT storm events

Description

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)

Title

Number of sustained VT events

Description

Total number of sustained VT (greater than 30 seconds)

Time Frame

8 years (including pilot study data)

Title

Number of ventricular arrhythmia events

Description

Time Frame

8 years (including pilot study data)

Title

Hospital admission for cardiac causes

Description

Hospitalizations greater than 24 hours due to a cardiovascular cause.

Time Frame

8 years (including pilot study data)

Title

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

Description

Periprocedural complications and adverse drug reactions will be assessed

Time Frame

8 years (including pilot study data)

Title

Time to any serious adverse events

Description

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)

Title

Side effects from anti-arrhythmic medication

Description

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)

Title

Quality of life - SF36

Description

Will include responses from the Short Form 36

Time Frame

8 years (including pilot study data)

Title

Quality of life - EQ5D

Description

Will include responses from the Euroquol 5D questionnaire

Time Frame

8 years (including pilot study data))

Title

Quality of life - HADS

Description

Will include responses from the Hospital Anxiety and Depression Scale quesionnaire

Time Frame

8 years (including pilot study data)

Title

Cost-effectiveness

Description

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

Time Frame

8 years (including pilot study data)

Title

Escalation and De-escalation of antiarrhythmic medication

Description

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John L Sapp, MD FRCPC

Organizational Affiliation

Nova Scotia Health Authority

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ratika Parkash, MD MSc FRCPC

Organizational Affiliation

Nova Scotia Health Authoriry

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Anthony L Tang, MD FRCPC

Organizational Affiliation

London Health Sciences Centre

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

George A Wells, BSc MSc PhD

Organizational Affiliation

Ottawa Heart Institute Research Corporation

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

William G Stevenson, MD

Organizational Affiliation

Brigham and Women's Hospital

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Jeff Healey, MD FRCPC

Organizational Affiliation

Population Health Research Institute, McMaster University

Official's Role

Study Director

Facility Information:

Facility Name

Vanderbilt University Hospital

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Facility Name

Foothills Hospital

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2W 1S7

Country

Canada

Facility Name

University of Alberta Hospital

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2B7

Country

Canada

Facility Name

Interior Health Authority

City

Kelowna

State/Province

British Columbia

ZIP/Postal Code

V1Y 1T2

Country

Canada

Facility Name

Fraser Health Authority - Royal Columbian Hospital

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V3T OH1

Country

Canada

Facility Name

St. Paul's Hospital

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6E 1M7

Country

Canada

Facility Name

Royal Jubilee Hospital

City

Victoria

State/Province

British Columbia

ZIP/Postal Code

V8R 1J8

Country

Canada

Facility Name

Nova Scotia Health Authority

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 3A7

Country

Canada

Facility Name

Hamilton Health Sciences Center

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8L 8E7

Country

Canada

Facility Name

Queen's University Health Sciences Centre

City

Kingston

State/Province

Ontario

ZIP/Postal Code

K7L 2V7

Country

Canada

Facility Name

St. Mary's Hospital

City

Kitchener

State/Province

Ontario

ZIP/Postal Code

N2M 1B2

Country

Canada

Facility Name

London Health Sciences Centre

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5A5

Country

Canada

Facility Name

University of Ottawa Heart Institute

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1Y 4W7

Country

Canada

Facility Name

St. Michael's Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5B 1W8

Country

Canada

Facility Name

Montreal Heart Institute

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1T 1C8

Country

Canada

Facility Name

McGill University Health Center

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3H 1A4

Country

Canada

Facility Name

Centre Hospitalier de l'Universitaire de Montreal

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H2X 0A9

Country

Canada

Facility Name

Institut Universitaire de cardiologie et pneumologie de Quebec - Laval University Hosptial

City

Quebec CIty

State/Province

Quebec

ZIP/Postal Code

G1V 4G5

Country

Canada

Facility Name

Centre Hospitalier Univesitaire de Sherbrooke

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H 5N4

Country

Canada

Facility Name

Hopitaux de Bordeaux

City

Bordeaux

State/Province

Acquitaine

ZIP/Postal Code

33604

Country

France

Facility Name

CHU - University Hospital Nancy

City

Nancy

State/Province

Meurthe-et-Moselle

ZIP/Postal Code

54511

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31698933

Citation

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.

Results Reference

derived

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Antiarrhythmics or Ablation for Ventricular Tachycardia 2

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