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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 30, 2014