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

NCT01122173 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2018-09-11

Study results available
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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).

Conditions

  • Paroxysmal Atrial Fibrillation

Interventions

DEVICE

Ablation

Atrial fibrillation ablation procedure

Sponsors & Collaborators

  • Hansen Medical

    lead INDUSTRY

Principal Investigators

  • Joseph Gallinghouse, M.D. · Texas Cardiac Arrhythmia Research Foundation

  • Andrea Natale, M.D. · Texas Cardiac Arrhythmia Research Foundation

  • Brenda Cayme, RN., BSN · Hansen Medical, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2017-04-30
Completion
2017-04-30

Countries

  • United States
  • Czechia
  • Denmark
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01122173 on ClinicalTrials.gov