Atrial Fibrillation
Conditions
Keywords
atrial fibrillation, paroxysmal, persistent, symptomatic, ablation, catheter, introducer, Agilis NxT, sinus rhythm, paroxysmal atrial fibrillation, persistent atrial fibrillation, symptomatic atrial fibrillation
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
Interventions
PROCEDURELeft atrial catheter ablation guided by introducer using Agilis sheeth
Left atrial catheter ablation guided by introducer using Agilis sheeth
PROCEDURELeft atrial catheter ablation guided by introducer using Non-steerable sheeth
Left atrial catheter ablation guided by introducer using Non-steerable sheeth
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| rate of patients in stable sinus rhythm (free of Atrial Fibrillation and Left Atrial Flutter) | 6 months post ablation |
Secondary
| Measure | 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 |
Countries
Germany
Outcome results
None listed