NCT01570361

Atrial Fibrillation Progression Trial

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 255 (actual)
• Sponsor: Biosense Webster, Inc. · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to determine whether early radiofrequency (RF) ablation treatment, using the CARTO® 3 or CARTO® XP System, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™) in subjects with paroxysmal atrial fibrillation (PAF), delays progression of atrial fibrillation (AF) compared with drug therapy (either rate or rhythm control) using current AF management guidelines.

Detailed description

Eligible PAF subjects with recurrent AF for 2 years who have failed no more than 2 prescribed drugs (with either anti-arrhythmic or rate control drug) are randomized into one of two study arms (catheter ablation or drug therapy).

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Catheter Ablation	Treat subjects with Paroxysmal Atrial Fibrillation (PAF)
DRUG	Drug Treatment	Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with current atrial fibrillation management guidelines.

Timeline

• Start date: 2012-02-13
• Primary completion: 2018-12-19
• Completion: 2018-12-19
• First posted: 2012-04-04
• Last updated: 2025-02-04
• Results posted: 2020-05-14

Regulatory

• FDA-regulated device study