Efficacy and Safety Study on Agilis NxT Introducer in AF Patients (AGILIS)

This study has been completed.
Sponsor:
Information provided by:
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00469638
First received: May 3, 2007
Last updated: April 21, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Procedure: Left atrial catheter ablation guided by introducer using Agilis sheeth
Procedure: Left atrial catheter ablation guided by introducer using Non-steerable sheeth

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Ablation Success With the Use of Steerable AGILIS NxT Introducer Compared With Conventionally Used Swartz SL0.

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • rate of patients in stable sinus rhythm (free of Atrial Fibrillation and Left Atrial Flutter) [ Time Frame: 6 months post ablation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 130
Study Start Date: May 2007
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Agilis sheeth group Procedure: Left atrial catheter ablation guided by introducer using Agilis sheeth
Left atrial catheter ablation guided by introducer using Agilis sheeth
Active Comparator: Non-steerable sheeth group Procedure: Left atrial catheter ablation guided by introducer using Non-steerable sheeth
Left atrial catheter ablation guided by introducer using Non-steerable sheeth

Detailed 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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00469638

Locations
Germany
Herzzenturm Leipzig
Leipzig, Germany, 04289
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Gerhard Hindricks, Prof. Dr. Herzzentrum Leipzig, Abteilung für Rhythmologie, Strümpellstraße 39, 04289 Leipzig, Germany
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alexander Huemmer, St Jude Medical Germany, GMBH
ClinicalTrials.gov Identifier: NCT00469638     History of Changes
Other Study ID Numbers: A07
Study First Received: May 3, 2007
Last Updated: April 21, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by St. Jude Medical:
atrial fibrillation
paroxysmal
persistent
symptomatic
ablation
catheter
introducer
Agilis NxT
sinus rhythm
paroxysmal atrial fibrillation
persistent atrial fibrillation
symptomatic atrial fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014