NCT01122173

Use of the Hansen Medical System in Patients With Paroxysmal Atrial Fibrillation

A Prospective, Single Arm Study of the Hansen System for Introducing and Positioning RF Ablation Catheters in Subjects With Paroxysmal Atrial Fibrillation

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Hansen Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and performance of the Hansen Medical Sensei Robotic System and Artisan Catheter when used to robotically manipulate RF ablation catheters for the treatment of paroxysmal atrial fibrillation (irregular heartbeats originating in the upper chambers of the heart).

Detailed description

Subjects who satisfy the inclusion and exclusion criteria will be treated with an RF ablation catheter and Artisan guide catheters controlled by the Sensei X Robotic Catheter System. Subject will be followed for a period of one year post ablation procedure. Follow up visit time frames will be conducted at 7-day, 30-day, 90-day, 180-day and 365-day.

Conditions

• Paroxysmal Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Ablation	Atrial fibrillation ablation procedure

Timeline

• Start date: 2013-07-01
• Primary completion: 2017-04-01
• Completion: 2017-04-01
• First posted: 2010-05-13
• Last updated: 2018-09-11
• Results posted: 2018-09-11

Locations

13 sites across 5 countries: United States, Czechia, Denmark, Spain, United Kingdom