Trial Comparing Ablation With Medical Therapy in Patients With Ventricular Tachycardia

Phase 3

Withdrawn

• Conditions: Ventricular Tachycardia; Coronary Artery Disease
• Interventions: Procedure: Catheter Ablation; Drug: Medical therapy (sotalol or amiodarone)

• Registration Number: NCT01798277
• Lead Sponsor: Newmarket Electrophysiology Research Group Inc

Brief Summary

This study aims to compare antiarrhythmic drug therapy with catheter ablation using the SmartTOUCH catheter (Biosense Webster Inc.) as treatment for patients with ventricular tachycardia and coronary artery disease

Detailed Description

This is a multicenter, randomized prospective cohort study to compare the impact of catheter ablation with antiarrhythmic drug therapy for treating patients with sustained ventricular tachycardia (VT) and coronary artery disease. Patients that meet all inclusion criteria and no exclusion criteria will be recruited to the study cohort. After baseline measurements are taken, patients will be randomized in a 2:1 fashion to either undergo radiofrequency catheter ablation or receive antiarrhythmic drug therapy (amiodarone or sotalol). The in-clinic appointments include: enrollment, baseline, intervention, and follow-up every three months for one year post-ablation. At each follow-up visit, electrogram (ECG) and Holter monitoring tests will be performed to measure any episodes of ventricular tachyarrhythmia. Furthermore, interrogation of the patient's implantable cardioverter defibrillator (ICD) will be performed at all follow-up visits to detect any episodes of ventricular tachyarrhythmia that required antitachycardia pacing (ATP) or shocks.

Study Timeline

• Study First Submitted: 2013-02-20
• Study First Submitted QC: 2013-02-21
• Study First Posted: 2013-02-25
• Study Start: 2013-04
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-26
• Last Update Posted: 2015-01-27
• Primary Completion: 2015-06
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Sustained monomorphic VT (>30 seconds, or requiring appropriate ICD therapy in patients with ICDs)
• Documented ischemic heart disease with no further options for revascularization
• Ability and willingness to give written informed consent to participate in the trial

Exclusion Criteria

• VT in the setting of metabolic abnormalities or acute ischemia if coronary lesions suitable for revascularization are identified.
• Acute ischemia with eligibility for revascularization
• Significant peripheral arterial disease preventing transvascular access to the left ventricle.
• Patients with arrhythmogenic right ventricular cardiomyopathy (ARVC), hypertrophic cardiomyopathy, Brugada syndrome, Long QT syndromes, dilated cardiomyopathy
• Prior long term therapy with a Class III or Class IC antiarrhythmic agent (longer than 2 weeks)
• Patient is or may be potentially pregnant
• Patient has a mechanical heart valve
• Myocardial infarction within the past 90 days
• Stroke within the past 90 days
• New York Heart Association (NYHA) functional class IV
• Hemorrhagic manifestations, bleeding diathesis, or impairment of hemostasis
• Lesions at risk of clinically significant bleeding (e.g., extensive cerebral infarction within the last 6 months, active peptic ulcer disease with recent bleeding)
• Prior VT ablation procedure
• Contraindication or allergy to contrast media, routine procedural medications or catheter materials
• Contraindications to an interventional procedure
• Life expectancy is less than 6 months
• Incessant or multiple episodes of VT requiring immediate therapy with medications or ablation
• Untreated hypothyroidism or hyperthyroidism (euthyroid or thyroid hrt is acceptable)
• Current enrolment in another investigational drug or device study
• There are other conditions present that the investigator feels would be problematic or would restrict or limit the participation for the patient for the entire study period
• Absolute contraindication to the use of heparin or warfarin
• Documented intra-arterial thrombus, ventricular thrombus, (less than 6 months after detection of thrombus), tumor or other abnormality that precludes catheter introduction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Catheter Ablation	Catheter Ablation	Radiofrequency ablation procedure
Medical therapy	Medical therapy (sotalol or amiodarone)	Antiarrhythmic drug therapy will include amiodarone or sotalol. Which antiarrhythmic drug will prescribed per patient depends on the observing physician.

Primary Outcome Measures

Name	Time	Method
Recurrence of Ventricular Tachycardia	1 year	Number of any appropriate ATPs/shocks and/or presentations of sustained (\>30sec) VT on Holter or ECG recording at 3, 6, 9 and 12 months after intervention

Secondary Outcome Measures

Name	Time	Method
QOL measures	1 year	Change in QOL measures at 6 and 12 months after intervention
Syncope	1 year	Change in syncope status at 3, 6, 9 and 12 months after intervention
Total mortality	1 year	Change in mortality status at 3, 6, 9 and 12 months after intervention
Time to First Shock/ATP for VT or to First Presentation of Sustained VT	1 year	Change in time to first ATP/shock or presentation of sustained (\>30sec) VT on Holter or ECG recording at 3, 6, 9 and 12 months after intervention
Sudden cardiac death	1 year	Change in sudden cardiac death status at 3, 6, 9 and 12 months after intervention
Number of hospitalizations	1 year	Change in number of hospitalizations at 3, 6, 9 and 12 months after intervention