Efficacy and Safety Study on Agilis NxT Introducer in AF Patients

Atrial Fibrillation Clinical Trial

— AGILIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00469638
• Other study ID #: A07
• Status: Completed
• Phase: N/A
• Start date: May 2007
• Est. completion date: April 2010

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
Germany	Herzzenturm Leipzig	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View 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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of patients in stable sinus rhythm (free of Atrial Fibrillation and Left Atrial Flutter)		6 months post ablation
Secondary	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