Trial Comparing Ablation With Medical Therapy in Patients With Ventricular Tachycardia

NCT ID: NCT01798277

Last Updated: 2015-01-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2015-12-31

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.

Conditions

Ventricular Tachycardia; Coronary Artery Disease

Study Design

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

Study Groups

Catheter Ablation

Radiofrequency ablation procedure

Group Type: ACTIVE_COMPARATOR

Catheter Ablation

Intervention Type: PROCEDURE

Catheter ablation of ventricular tachycardia will employ three-dimensional mapping Fast Anatomical Mapping or CARTOSOUND technology (Biosense Webster Inc.), and the Thermocool Navistar catheter (Biosense Webster Inc.).

Medical therapy

Antiarrhythmic drug therapy will include amiodarone or sotalol. Which antiarrhythmic drug will prescribed per patient depends on the observing physician.

Group Type: ACTIVE_COMPARATOR

Medical therapy (sotalol or amiodarone)

Intervention Type: DRUG

Patients will be tiered to one of two possible antiarrhythmic drugs (sotalol or amiodarone).

Interventions

Catheter Ablation

Catheter ablation of ventricular tachycardia will employ three-dimensional mapping Fast Anatomical Mapping or CARTOSOUND technology (Biosense Webster Inc.), and the Thermocool Navistar catheter (Biosense Webster Inc.).

Intervention Type: PROCEDURE

Medical therapy (sotalol or amiodarone)

Patients will be tiered to one of two possible antiarrhythmic drugs (sotalol or amiodarone).

Intervention Type: DRUG

Other Intervention Names

Ablation of: - Ischemic ventricular tachycardia; - Sustained monomorphic ventricular tachycardia; - Clinical ventricular tachycardia; - Hemodynamically stable/unstable ventricular tachycardia; Sotalol - Betapace, Betapace AF, Sotalex, Sotacor

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biosense Webster, Inc.

INDUSTRY

Sponsor Role: collaborator

Newmarket Electrophysiology Research Group Inc

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yaariv Khaykin, MD

Role: PRINCIPAL_INVESTIGATOR

Newmarket Electrophysiology Research Group

Other Identifiers

NERG-02

Identifier Type: -

Identifier Source: org_study_id