Status:
COMPLETED
Efficacy and Safety Study on Agilis NxT Introducer in AF Patients
Lead Sponsor:
Abbott Medical Devices
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-75 years
Phase:
NA
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2010
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00469638
Start Date
May 1 2007
End Date
April 1 2010
Last Update
February 4 2019
Active Locations (1)
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1
Herzzenturm Leipzig
Leipzig, Germany, 04289