Ventricular Tachycardia (VT) Ablation or Escalated Drug Therapy

NCT ID: NCT00905853

Last Updated: 2016-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2015-12-31

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.

Conditions

Recurrent Ventricular Tachycardia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ventricular Tachycardia Ablation

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

Group Type: ACTIVE_COMPARATOR

Catheter Ablation

Intervention Type: PROCEDURE

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.

Escalated Antiarrhythmic Drug Therapy

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.

Group Type: ACTIVE_COMPARATOR

Escalated Antiarrhythmic Therapy

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: PROCEDURE

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

Intervention Type: DRUG

Other Intervention Names

VT Ablation; Cordarone; Mexetil

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: collaborator

Biosense Webster, Inc.

INDUSTRY

Sponsor Role: collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

John Sapp

OTHER

Sponsor Role: lead

Responsible Party

John Sapp

Staff physician, Division of Cardiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

John L Sapp, BSc, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Nova Scotia Health Authority

Ratika Parkash, MD, MSc, FRCPC

Role: STUDY_DIRECTOR

Nova Scotia Health Authority

Anthony S Tang, MSc, MD, FRCPC

Role: STUDY_DIRECTOR

Royal Jubilee Hospital

George A Wells, BSc,MSc,PhD

Role: STUDY_DIRECTOR

Univeristy of Ottawa Heart Institute

William G Stevenson, MD

Role: STUDY_DIRECTOR

Brigham and Women's Hospital

Locations

QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Countries

Canada

References

Parkash R, Nault I, Rivard L, Gula L, Essebag V, Nery P, Tung S, Raymond JM, Sterns L, Doucette S, Wells G, Tang ASL, Stevenson WG, Sapp JL. Effect of Baseline Antiarrhythmic Drug on Outcomes With Ablation in Ischemic Ventricular Tachycardia: A VANISH Substudy (Ventricular Tachycardia Ablation Versus Escalated Antiarrhythmic Drug Therapy in Ischemic Heart Disease). Circ Arrhythm Electrophysiol. 2018 Jan;11(1):e005663. doi: 10.1161/CIRCEP.117.005663.

Reference Type: DERIVED

PMID: 29305400 (View on PubMed)

Sapp JL, Wells GA, Parkash R, Stevenson WG, Blier L, Sarrazin JF, Thibault B, Rivard L, Gula L, Leong-Sit P, Essebag V, Nery PB, Tung SK, Raymond JM, Sterns LD, Veenhuyzen GD, Healey JS, Redfearn D, Roux JF, Tang AS. Ventricular Tachycardia Ablation versus Escalation of Antiarrhythmic Drugs. N Engl J Med. 2016 Jul 14;375(2):111-21. doi: 10.1056/NEJMoa1513614. Epub 2016 May 5.

Reference Type: DERIVED

PMID: 27149033 (View on PubMed)

Related Links

http://www.nejm.org/doi/full/10.1056/NEJMoa1513614

Publication

Other Identifiers

Sapp001

Identifier Type: -

Identifier Source: org_study_id