NCT00578617

Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial

Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation - Pilot Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The CABANA pilot study is designed to test the hypothesis that the treatment strategy of percutaneous left atrial catheter ablation for the purpose of the elimination of atrial fibrillation (AF) is superior to current state-of-the-art therapy with either rate control or anti-arrhythmic drugs for reducing AF recurrences at 1 year follow-up.

Detailed description

The need for this trial arises out of 1) the rapidly increasing number of pts \> 60 years of age with AF accompanied by symptoms and morbidity, 2) the failure of anti-arrhythmic drug therapy to maintain sinus rhythm and reduce mortality, 3) the rapidly increasing application of radio-frequency catheter ablation without appropriate evidence-based validation, and 4) the expanding impact of AF on health care costs.

Conditions

• Atrial Fibrillation
• Arrhythmia

Interventions

Type	Name	Description
DRUG	Rate Control	Metoprolol 50-100mg
DEVICE	Ablation Therapy
DRUG	Rate Control	Atenolol 50-100mg,
DRUG	Rate control	Propranolol 40-80mg
DRUG	Rate control	Acebutolol 200mg
DRUG	Rate control	Carvedilol 6.25mg
DRUG	Rate Control	Diltiazem 180-240mg
DRUG	Rate Control	Verapamil 180-240mg
DRUG	Rate Control	Digoxin 0.125mg
DRUG	Rhythm Control	Propafenone 450mg
DRUG	Rhythm control	Flecainide 200mg
DRUG	Rhythm control	Sotalol 240mg
DRUG	Rhythm control	Dofetilide 500mcg
DRUG	Rhythm control	Amiodarone 200mg
DRUG	Rhythm control	Quinidine 600-900mg

Timeline

• Start date: 2006-09-01
• Primary completion: 2009-02-01
• Completion: 2010-06-01
• First posted: 2007-12-21
• Last updated: 2013-01-04
• Results posted: 2013-01-04

Locations

10 sites across 1 country: United States