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| Name | Class |
|---|---|
| Abbott Medical Devices | INDUSTRY |
| Biosense Webster, Inc. | INDUSTRY |
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ventricular Tachycardia Ablation | Active Comparator | Catheter ablation for Ventricular tachycardia will be performed within 14 days of randomization. |
|
| Escalated Antiarrhythmic Drug Therapy | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheter Ablation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Appropriate ICD shocks,VT storm and death | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality | 3 years | |
| Appropriate ICD antitachycardia pacing anytime and after 1 month treatment period | 3 years | |
| appropriate ICD shocks anytime and after 1 month treatment period |
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Inclusion Criteria:
Prior Myocardial Infarction
An implantable defibrillator
One of the following VT events (within the past 3 months):
"Failed" first-line antiarrhythmic drug therapy as defined by one of:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John L Sapp, BSc, MD, FRCPC | Nova Scotia Health Authority | Principal Investigator |
| Ratika Parkash, MD, MSc, FRCPC | Nova Scotia Health Authority | Study Director |
| Anthony S Tang, MSc, MD, FRCPC | Royal Jubilee Hospital | Study Director |
| George A Wells, BSc,MSc,PhD | Univeristy of Ottawa Heart Institute | Study Director |
| William G Stevenson, MD | Brigham and Women's Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| QEII Health Sciences Centre | Halifax | Nova Scotia | B3H 3A7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29305400 | Derived | 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. | |
| 27149033 |
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| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| D000638 | Amiodarone |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
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|
|
| Escalated Antiarrhythmic Therapy | 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 |
|
|
| 3 years |
| Inappropriate shocks anytime and after 1 month treatment period | 3 years |
| VT storm anytime and after 1 month treatment period | 3 years |
| Documented sustained VT below detection rate of the ICD any time and after 1 month treatment period | 3 years |
| Number of ICD shocks | 3 years |
| Hospital admission for cardiac causes | 3 years |
| Procedural complications, amiodarone toxicity or adverse events | 3 years |
| Derived |
| 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. |
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |