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

Abbott

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Procedure: Left atrial catheter ablation guided by introducer using Non-steerable sheeth; Procedure: Left atrial catheter ablation guided by introducer using Agilis sheeth

Study type: Interventional

Funder types: Industry

Identifiers

NCT00469638

A07

Details and patient eligibility

About

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.

Full 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

Enrollment: 130 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 2 patient groups

Agilis sheeth group

Experimental group

Treatment:

Procedure: Left atrial catheter ablation guided by introducer using Agilis sheeth

Non-steerable sheeth group

Active Comparator group

Treatment:

Procedure: Left atrial catheter ablation guided by introducer using Non-steerable sheeth