Trial Comparing Ablation With Medical Therapy in Patients With Ventricular Tachycardia

Coronary Artery Disease Clinical Trial

— VeTAMed  

Official title:

Ablation Versus Medical Therapy in Patients With Coronary Artery Disease and Sustained Ventricular Tachycardia Randomized Trial (VeTAMed)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01798277
• Other study ID #: NERG-02
• Status: Withdrawn
• Phase: Phase 3
• First received: February 20, 2013
• Last updated: January 26, 2015
• Start date: April 2013
• Est. completion date: December 2015

Study information

• Verified date: January 2015
• Source: Newmarket Electrophysiology Research Group Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• 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.).

Drug:
• Medical therapy (sotalol or amiodarone)
Patients will be tiered to one of two possible antiarrhythmic drugs (sotalol or amiodarone).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Newmarket Electrophysiology Research Group Inc	Biosense Webster, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of Ventricular Tachycardia	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	1 year	No
Secondary	Time to First Shock/ATP for VT or to First Presentation of Sustained VT	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	1 year	No
Secondary	Total mortality	Change in mortality status at 3, 6, 9 and 12 months after intervention	1 year	No
Secondary	Sudden cardiac death	Change in sudden cardiac death status at 3, 6, 9 and 12 months after intervention	1 year	No
Secondary	Syncope	Change in syncope status at 3, 6, 9 and 12 months after intervention	1 year	No
Secondary	Number of hospitalizations	Change in number of hospitalizations at 3, 6, 9 and 12 months after intervention	1 year	No
Secondary	QOL measures	Change in QOL measures at 6 and 12 months after intervention	1 year	No