NCT00514735

Tailored Treatment of Permanent Atrial Fibrillation

Tailored Treatment of Permanent Atrial Fibrillation - TTOP-AF

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to evaluate the safety and efficacy of the Medtronic Cardiac Ablation System compared to medical therapy in the persistent and long-standing persistent atrial fibrillation population.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	Medtronic Cardiac Ablation System	Arm 1 (Ablation Management): Ablation procedures using investigational catheters in left atrium. Cardioversion could be used to restore sinus rhythm if needed.
DRUG	Class I or III Antiarrhythmic Medications	Arm 2 (Medical Management): Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current cardioversions were also allowed at the discretion of the investigator.

Timeline

• Start date: 2007-05-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2007-08-10
• Last updated: 2018-10-16
• Results posted: 2012-05-09

Locations

24 sites across 2 countries: United States, Netherlands