Efficacy and Safety Study on Agilis NxT Introducer in AF Patients

Last updated: February 1, 2019
Sponsor: Abbott Medical Devices
Overall Status: Completed

Phase

N/A

Condition

Chest Pain

Dysrhythmia

Atrial Fibrillation

Treatment

N/A

Clinical Study ID

NCT00469638
A07
  • Ages 18-75
  • All Genders

Study Summary

To prove if the success rate of curative treatment of atrial fibrillation in left atrial circumferential pulmonary vein ablation is higher by using a steerable transseptal introducer giving access to the left atrium then by using a conventionally introducer with fixed curve.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Paroxysmal or persistent symptomatic atrial fibrillation

  • Resistant to at least 1 anti arrhythmic drug

  • Left atrial diameter less then 60 mm (TTE, parasternal)

  • Atrial fibrillation documented by ECG

  • Patient is willing and available to perform all Follow Ups

Exclusion

Exclusion Criteria:

  • Permanent atrial fibrillation

  • Pre existing left atrial fibrillation ablation

  • Atrial fibrillation due to reversible cause

  • Known intracardiac or other thrombi

  • Pregnancy

  • Women of child bearing potential without negative pregnancy test within 48 hours priorto ablation

  • Contraindication for anticoagulation

Study Design

Total Participants: 130
Study Start date:
May 01, 2007
Estimated Completion Date:
April 30, 2010

Study Description

To prove if the success rate of curative treatment of atrial fibrillation in left atrial circumferential pulmonary vein ablation is higher by using a steerable transseptal introducer giving access to the left atrium then by using a conventionally introducer with fixed curve; in patients with paroxysmal or persistent symptomatic Atrial Fibrillation.

Primary Endpoint: rate of patients in stable sinus rhythm at 6 Month Follow Up

Connect with a study center

  • Herzzenturm Leipzig

    Leipzig, 04289
    Germany

    Site Not Available

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