Trial Comparing Ablation With Medical Therapy in Patients With Ventricular Tachycardia

NCT01798277 | Withdrawn Phase 3

• 1 other identifier: NERG-02
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Ventricular Tachycardia; Coronary Artery Disease

Keywords

Keywords provided by Newmarket Electrophysiology Research Group Inc:; Ventricular tachycardia; Ventricular tachyarrhythmia; Ablation; Coronary artery disease; Ischemic heart disease; Amiodarone; Sotalol; Anti-Arrhythmia Agents; Therapeutic Uses; Pharmacologic Actions; Additional relevant MeSH terms:; Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Catheter Ablation, Radiofrequency

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

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

  1 year

• Total mortality

  1 year

• Sudden cardiac death

  1 year

• Syncope

  1 year

• Number of hospitalizations

  1 year

Study Arms (2)

Catheter Ablation

ACTIVE COMPARATOR

Radiofrequency ablation procedure

Procedure: Catheter Ablation

Medical therapy

ACTIVE COMPARATOR

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

Drug: Medical therapy (sotalol or amiodarone)

Interventions

Catheter Ablation 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.).

Also known as: Ablation of:, - Ischemic ventricular tachycardia, - Sustained monomorphic ventricular tachycardia, - Clinical ventricular tachycardia, - Hemodynamically stable/unstable ventricular tachycardia

Catheter Ablation

Medical therapy (sotalol or amiodarone) DRUG

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

Also known as: Sotalol - Betapace, Betapace AF, Sotalex, Sotacor

Medical therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Newmarket Electrophysiology Research Group Inc: lead
• Biosense Webster, Inc.: collaborator

MeSH Terms

Conditions

Tachycardia, Ventricular; Coronary Artery Disease; Myocardial Ischemia; Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes

Interventions

Catheter Ablation; Sotalol; Amiodarone

Condition Hierarchy (Ancestors)

Tachycardia; Cardiac Conduction System Disease; Pathological Conditions, Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Yaariv Khaykin, MD

  Newmarket Electrophysiology Research Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2013
• First Posted: February 25, 2013
• Study Start: April 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 27, 2015

Record last verified: 2015-01