Efficacy and Safety Study on Agilis NxT Introducer in AF Patients

Study Overview
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Brief Summary
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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
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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

Official Title
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Ablation Success With the Use of Steerable AGILIS NxT Introducer Compared With Conventionally Used Swartz SL0.

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: Left atrial catheter ablation guided by introducer using Agilis sheeth
* Procedure: Left atrial catheter ablation guided by introducer using Non-steerable sheeth


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Agilis sheeth group<br> | Procedure: Left atrial catheter ablation guided by introducer using Agilis sheeth<br>* Left atrial catheter ablation guided by introducer using Agilis sheeth<br>|
| Active Comparator: Non-steerable sheeth group<br> | Procedure: Left atrial catheter ablation guided by introducer using Non-steerable sheeth<br>* Left atrial catheter ablation guided by introducer using Non-steerable sheeth<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of patients in stable sinus rhythm (free of Atrial Fibrillation and Left Atrial Flutter) |  | 6 months post ablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 6 month post ablation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, paroxysmal, persistent, symptomatic, ablation, catheter, introducer, Agilis NxT, sinus rhythm, paroxysmal atrial fibrillation, persistent atrial fibrillation, symptomatic atrial fibrillation