NCT01687166

Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 398 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to establish the safety and effectiveness of the Blazer Open-Irrigated radiofrequency ablation catheter for the treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation.

Detailed description

The ZERO-AF trial is a prospective, multicenter, single blind, 1:1 randomized study. The trial is designed to demonstrate that the safety and effectiveness of the Blazer® Open-Irrigated Ablation Catheter are non-inferior to the safety and effectiveness of the control catheters, for the treatment drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation. The control catheters are open-irrigated radiofrequency ablation catheters that are approved in the United States for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems.

Conditions

• Paroxysmal Atrial Fibrillation (PAF)

Interventions

Type	Name	Description
DEVICE	Blazer Open-Irrigated Ablation Catheter (Boston Scientific)
DEVICE	FDA Approved Open-Irrigated Ablation Catheter

Timeline

• Start date: 2012-10-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2012-09-18
• Last updated: 2018-11-21
• Results posted: 2018-06-18

Locations

38 sites across 9 countries: United States, Australia, Czechia, France, Germany, Portugal, Spain, Sweden, United Kingdom