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Trial Comparing Ablation With Medical Therapy in Patients With Ventricular Tachycardia

Information source: Newmarket Electrophysiology Research Group Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ventricular Tachycardia; Coronary Artery Disease

Intervention: Catheter Ablation (Procedure); Medical therapy (sotalol or amiodarone) (Drug)

Phase: Phase 3

Status: Withdrawn

Sponsored by: Newmarket Electrophysiology Research Group Inc

Official(s) and/or principal investigator(s):
Yaariv Khaykin, MD, Principal Investigator, Affiliation: Newmarket Electrophysiology Research Group

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

Clinical Details

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

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

Primary outcome: Recurrence of Ventricular Tachycardia

Secondary outcome:

Time to First Shock/ATP for VT or to First Presentation of Sustained VT

Total mortality

Sudden cardiac death

Syncope

Number of hospitalizations

QOL measures

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.

Eligibility

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: April 2013
Last updated: January 26, 2015

Page last updated: August 23, 2015

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