Efficacy and Safety Study on Agilis NxT Introducer in AF Patients - Full Text View

Sponsored by:	St. Jude Medical
Information provided by:	St. Jude Medical
ClinicalTrials.gov Identifier:	NCT00469638

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

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Ablation Success With the Use of Steerable AGILIS NxT Introducer Compared With Conventionally Used Swartz SL0.

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 ]

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 ]

Estimated Enrollment:	130
Study Start Date:	May 2007
Estimated Study Completion Date:	November 2008

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

Contacts

Contact: Gerhard Hindricks, Prof. Dr.

+49 341 865 1421

Locations

Germany
Herzzenturm Leipzig	Recruiting
Leipzig, Germany, 04289
Principal Investigator: Gerhard Hindricks, Prof. Dr.

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:

Kannel WB, Abbott RD, Savage DD, McNamara PM. Epidemiologic features of chronic atrial fibrillation: the Framingham study. N Engl J Med. 1982 Apr 29;306(17):1018-22.

Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke. 1991 Aug;22(8):983-8.

Piorkowski C, Hindricks G, Weiss S et al: Long term outcome of circumferential left atrial PV ablation using a steerable transseptal sheath. Poster European Society of Cardiology 2006, Barcelona

Study ID Numbers:	A07
Study First Received:	May 3, 2007
Last Updated:	August 7, 2007
ClinicalTrials.gov Identifier:	NCT00469638
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

Study placed in the following topic categories:

Heart Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009