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Ventricular Tachycardia (VT) Ablation or Escalated Drug Therapy (VANISH)

Primary Purpose

Recurrent Ventricular Tachycardia

Status

Completed

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Catheter Ablation

Escalated Antiarrhythmic Therapy

About this trial

This is an interventional treatment trial for Recurrent Ventricular Tachycardia focused on measuring Ventricular Tachycardia, Catheter Ablation, ICD therapy, Antiarrhythmic Drug Therapy, Ischemic Heart Disease

Eligibility Criteria

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

Inclusion Criteria:

Prior Myocardial Infarction
An implantable defibrillator
One of the following VT events (within the past 3 months):
- greater than or equal to 3 episodes of symptomatic VT treated with ATP
- greater than or equal to 1 appropriate ICD shock
- greater than or equal to 3 VT episodes within 24 hours
- sustained VT below detection rate of the ICD documented by ECG
"Failed" first-line antiarrhythmic drug therapy as defined by one of:
- Appropriate ICD therapy or sustained VT occurred while patient was taking amiodarone (stable dose >/= 2 weeks)
- Appropriate ICD therapy or sustained VT occurred on another antiarrhythmic drug (stable dose >/= 2 weeks)

Exclusion Criteria:

Active ischemia (acute thrombus, dynamic ST elevation on ECG) or another reversible cause of VT (eg. electrolyte abnormalities, drug induced arrhythmia)
Are known to be ineligible to take amiodarone (eg. active hepatitis, current hyperthyroidism, pulmonary fibrosis, known allergy)
Are ineligible for ablation (left ventricular thrombus, implanted mechanical aortic and mitral valves)
Renal Failure (creatinine clearance < 15 ml/min)
Current NYHA functional class IV heart failure or CCS Functional Class IV angina
Recent ST elevation myocardial infarction (< 1 month)
Recent coronary bypass surgery (< 3 mon) or recent PCI (< 1 mon)
Pregnant
prior ablation for ventricular tachycardia
A systemic illness likely to limit survival to < 1 year
Unable or unwilling to provide informed consent

Sites / Locations

QEII Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Ventricular Tachycardia Ablation

Escalated Antiarrhythmic Drug Therapy

Arm Description

Catheter ablation for Ventricular tachycardia will be performed within 14 days of randomization.

Patients are prescribed a loading dose of amiodarone or the addition of mexiletine to their current anti-arrhythmic medication which is stratified by the dose and type of antiarrhymic medication at the time of the index arrhythmic event.

Outcomes

Primary Outcome Measures

Appropriate ICD shocks,VT storm and death

Secondary Outcome Measures

All cause mortality

Appropriate ICD antitachycardia pacing anytime and after 1 month treatment period

appropriate ICD shocks anytime and after 1 month treatment period

Inappropriate shocks anytime and after 1 month treatment period

VT storm anytime and after 1 month treatment period

Documented sustained VT below detection rate of the ICD any time and after 1 month treatment period

Number of ICD shocks

Hospital admission for cardiac causes

Procedural complications, amiodarone toxicity or adverse events

Full Information

NCT ID

NCT00905853

First Posted

May 20, 2009

Last Updated

July 8, 2016

Sponsor

John Sapp

Collaborators

Abbott Medical Devices, Biosense Webster, Inc., Canadian Institutes of Health Research (CIHR)

1. Study Identification

Unique Protocol Identification Number

NCT00905853

Brief Title

Ventricular Tachycardia (VT) Ablation or Escalated Drug Therapy

Acronym

VANISH

Official Title

Ventricular Tachycardia Ablation or Escalated aNtiarrhythmic Drugs in ISchemic Heart Disease

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

May 2009 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

John Sapp

Collaborators

Abbott Medical Devices, Biosense Webster, Inc., Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study will compare aggressive antiarrhythmic therapy to catheter ablation for ventricular tachycardia in patients who have suffered prior myocardial infarction. The purpose of this study is to evaluate the optimal management of patients presenting with recurrent VT and receiving ICD therapy in spite of first-line antiarrhythmic drug therapy. The hypothesis is catheter ablation is superior to aggressive antiarrhythmic drug therapy for recurrent VT.

Detailed Description

This is a multicentre, parallel group, two arm, unblinded, randomized clinical trial to compare two management strategies for patients with ischemic heart disease and recurrent ICD therapy despite at least one antiarrhythmic drug. The primary endpoint will be a composite of appropriate ICD shocks or death.

6. Conditions and Keywords

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

Recurrent Ventricular Tachycardia

Keywords

Ventricular Tachycardia, Catheter Ablation, ICD therapy, Antiarrhythmic Drug 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

260 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ventricular Tachycardia Ablation

Arm Type

Active Comparator

Arm Description

Catheter ablation for Ventricular tachycardia will be performed within 14 days of randomization.

Arm Title

Escalated Antiarrhythmic Drug Therapy

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Escalated Antiarrhythmic Therapy

Other Intervention Name(s)

Cordarone, Mexetil

Intervention Description

Patients who have 'failed' antiarrhythmic therapy (except amiodarone) will be prescribed: Amiodarone 400 mg twice daily for 2 weeks, followed by 400 mg/day for 4 weeks, followed by 200 mg/day thereafter. Patients who 'failed' amiodarone (less than 300mg/day) will be prescribed: Amiodarone 400 mg three times a day for 2 weeks, followed by 400 mg/day for 1 week and 300 mg/day thereafter. Patients who 'failed' amiodarone (greater or equal to 300mg/day) will be prescribed: Amiodarone at the current dose with the addition of mexiletine 400 to 800 mg/day

Primary Outcome Measure Information:

Title

Appropriate ICD shocks,VT storm and death

Time Frame

3 years

Secondary Outcome Measure Information:

Title

All cause mortality

Time Frame

3 years

Title

Appropriate ICD antitachycardia pacing anytime and after 1 month treatment period

Time Frame

3 years

Title

appropriate ICD shocks anytime and after 1 month treatment period

Time Frame

3 years

Title

Inappropriate shocks anytime and after 1 month treatment period

Time Frame

3 years

Title

VT storm anytime and after 1 month treatment period

Time Frame

3 years

Title

Documented sustained VT below detection rate of the ICD any time and after 1 month treatment period

Time Frame

3 years

Title

Number of ICD shocks

Time Frame

3 years

Title

Hospital admission for cardiac causes

Time Frame

3 years

Title

Procedural complications, amiodarone toxicity or adverse events

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Prior Myocardial Infarction An implantable defibrillator One of the following VT events (within the past 3 months): greater than or equal to 3 episodes of symptomatic VT treated with ATP greater than or equal to 1 appropriate ICD shock greater than or equal to 3 VT episodes within 24 hours sustained VT below detection rate of the ICD documented by ECG "Failed" first-line antiarrhythmic drug therapy as defined by one of: Appropriate ICD therapy or sustained VT occurred while patient was taking amiodarone (stable dose >/= 2 weeks) Appropriate ICD therapy or sustained VT occurred on another antiarrhythmic drug (stable dose >/= 2 weeks) Exclusion Criteria: Active ischemia (acute thrombus, dynamic ST elevation on ECG) or another reversible cause of VT (eg. electrolyte abnormalities, drug induced arrhythmia) Are known to be ineligible to take amiodarone (eg. active hepatitis, current hyperthyroidism, pulmonary fibrosis, known allergy) Are ineligible for ablation (left ventricular thrombus, implanted mechanical aortic and mitral valves) Renal Failure (creatinine clearance < 15 ml/min) Current NYHA functional class IV heart failure or CCS Functional Class IV angina Recent ST elevation myocardial infarction (< 1 month) Recent coronary bypass surgery (< 3 mon) or recent PCI (< 1 mon) Pregnant prior ablation for ventricular tachycardia A systemic illness likely to limit survival to < 1 year Unable or unwilling to provide informed consent

Overall Study Officials: