Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial

Summary

The (Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial) CABANA Trial has the overall goal of establishing the appropriate roles for medical and ablative intervention for atrial fibrillation (AF). The CABANA Trial is designed to test the hypothesis that the treatment strategy of left atrial catheter ablation for the purpose of eliminating atrial fibrillation (AF) will be superior to current state-of-the-art therapy with either rate control or rhythm control drugs for decreasing the incidence of the composite endpoint of total mortality, disabling stroke, serious bleeding, or cardiac arrest in patients with untreated or incompletely treated AF.

Conditions

• Atrial Fibrillation
• Arrhythmia

Interventions

DEVICE

Left atrial ablation

St. Jude: Livewire TC™ , Therapy™ Dual / Thermocouple, Safire,Therapy Cool Path Biosense Webster: NAVI-STAR, NAVI-STAR/NAVI-STAR DS, Celsius Braided/Long Tip, NAVI-STAR™ and Celsius™ ThermoCool, NAVI-STAR® RMT, Celsius® RMT, ThermoCool® SF Medtronic CryoCath LP: Freezor®/Freezor MAX®, Artic Front®, Cardiac Ablation System Bard: Stinger Boston Scientific: Blazer II RF/XP, Blazer RPM, Chilli II Cooled, SteeroCath

DRUG

Rate or Rhythm Control Therapy

Rate control: Metoprolol 50-100mg, Atenolol 50-100mg, Propranolol 40-80mg, Acebutolol 200-300mg, Carvedilol 6.25-25mg, Diltiazem 180-240mg, Verapamil 180-240mg, Digoxin 0.125-0.25mg Rhythm control: Propafenone 450-625mg, Flecainide 200-300mg, Sotalol 240-320mg, Dofetilide 500-1000mcg, Amiodarone 200-400mg, Quinidine 600-900mg, Dronedarone 800mg

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Abbott Medical Devices

  collaborator INDUSTRY

• Biosense Webster, Inc.

  collaborator INDUSTRY

• Mayo Clinic

  lead OTHER

Principal Investigators

• Douglas L. Packer, M.D. · Mayo Clinic

• Kerry L. Lee, Ph.D. · Duke Clinical Research Institute

• Daniel B. Mark, M.D., MPH · Duke Clinical Research Institute

• Rich A. Robb, Ph.D. Phy · Mayo Clinic

• Yves D. Rosenberg, M.D., MPH · National Heart, Lung, and Blood Institute (NHLBI)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-11-13

Primary Completion

2017-12-31

Completion

2017-12-31

Countries

• United States
• Australia
• Canada
• China
• Czechia
• Germany
• Italy
• Russia
• South Korea
• United Kingdom

Study Locations