Ventricular Tachycardia (VT) Ablation or Escalated Drug Therapy

Recurrent Ventricular Tachycardia Clinical Trial

— VANISH  

Official title:

Ventricular Tachycardia Ablation or Escalated aNtiarrhythmic Drugs in ISchemic Heart Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00905853
• Other study ID #: Sapp001
• Status: Completed
• Phase: Phase 4
• First received: May 20, 2009
• Last updated: July 8, 2016
• Start date: May 2009
• Est. completion date: December 2015

Study information

• Verified date: July 2016
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Myocardial Ischemia
• Recurrent Ventricular Tachycardia
• Tachycardia
• Tachycardia, Ventricular

Intervention

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.

Drug:
• Escalated Antiarrhythmic Therapy
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

Locations

Country	Name	City	State
Canada	QEII Health Sciences Centre	Halifax	Nova Scotia

Sponsors (4)

Lead Sponsor	Collaborator
John Sapp	Biosense Webster, Inc., Canadian Institutes of Health Research (CIHR), St. Jude Medical

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Appropriate ICD shocks,VT storm and death		3 years	No
Secondary	All cause mortality		3 years	No
Secondary	Appropriate ICD antitachycardia pacing anytime and after 1 month treatment period		3 years	No
Secondary	appropriate ICD shocks anytime and after 1 month treatment period		3 years	No
Secondary	Inappropriate shocks anytime and after 1 month treatment period		3 years	No
Secondary	VT storm anytime and after 1 month treatment period		3 years	No
Secondary	Documented sustained VT below detection rate of the ICD any time and after 1 month treatment period		3 years	No
Secondary	Number of ICD shocks		3 years	No
Secondary	Hospital admission for cardiac causes		3 years	No
Secondary	Procedural complications, amiodarone toxicity or adverse events		3 years	Yes

External Links

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