Ablation Success With the Use of Steerable AGILIS NxT Introducer Compared With Conventionally Used Swartz SL0.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott Medical Devices
- Enrollment
- 130
- Locations
- 2
- Primary Endpoint
- rate of patients in stable sinus rhythm (free of Atrial Fibrillation and Left Atrial Flutter)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
rate of patients in stable sinus rhythm (free of Atrial Fibrillation and Left Atrial Flutter)
Time Frame: 6 months post ablation
Secondary Outcomes
- 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)