Clinical trial NCT00469638: Efficacy and Safety Study on Agilis NxT Introducer in AF Patients
Official title: Ablation Success With the Use of Steerable AGILIS NxT Introducer Compared With Conventionally Used Swartz SL0.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
paroxysmal
persistent
symptomatic
ablation
catheter
introducer
Agilis NxT
sinus rhythm
paroxysmal atrial fibrillation
persistent atrial fibrillation
symptomatic atrial fibrillation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2007-05-04
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: rate of patients in stable sinus rhythm (free of Atrial Fibrillation and Left Atrial Flutter)
timeFrame: 6 months post ablation
Secondary outcomes:
measure: 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
timeFrame: 6 month post ablation
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Herzzenturm Leipzig
Study officials:
affiliation: Herzzentrum Leipzig, Abteilung für Rhythmologie, Strümpellstraße 39, 04289 Leipzig, Germany
name: Gerhard Hindricks, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1056/NEJM198204293061703.
citation: 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. doi: 10.1161/01.str.22.8.983.
citation: 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
citation: 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;4(2):157-65. doi: 10.1161/CIRCEP.110.957761. Epub 2011 Jan 19.