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

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:

Genetics Home Reference related topics: familial atrial fibrillation

MedlinePlus related topics: Atrial Fibrillation

U.S. FDA Resources

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:

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

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Piorkowski C, Eitel C, Rolf S, Bode K, Sommer P, Gaspar T, Kircher S, Wetzel U, Parwani AS, Boldt LH, Mende M, Bollmann A, Husser D, Dagres N, Esato M, Arya A, Haverkamp W, Hindricks G. Steerable versus nonsteerable sheath technology in atrial fibrillation ablation: a prospective, randomized study. Circ Arrhythm Electrophysiol. 2011 Apr 1;4(2):157-65. Epub 2011 Jan 19.

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 May 23, 2013

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