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OpenTrials
Completed

NCT Number: NCT00469638

Efficacy and Safety Study on Agilis NxT Introducer in AF Patients

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Herzzenturm Leipzig

Leipzig, 04289, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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 prior to ablation
  • Contraindication for anticoagulation

Treatment and study plan

Left atrial catheter ablation guided by introducer using Agilis sheeth

Procedure

Left atrial catheter ablation guided by introducer using Agilis sheeth

Left atrial catheter ablation guided by introducer using Non-steerable sheeth

Procedure

Left atrial catheter ablation guided by introducer using Non-steerable sheeth

Primary outcomes

  1. rate of patients in stable sinus rhythm (free of Atrial Fibrillation and Left Atrial Flutter)

    Time frame: 6 months post ablation

Secondary outcomes

  1. rate of patients in stable sinus rhythm (free of Atrial Fibrillation and Left Atrial Flutter) at 3 months post ablation rate of pulmonary vein isolation completely isolated rate of complications procedure duration X-ray duration

    Time frame: 6 month post ablation

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Ablation Success With the Use of Steerable AGILIS NxT Introducer Compared With Conventionally Used Swartz SL0.

Acronym: AGILIS

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
May 4, 2007
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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