ear zero-fluoroscopy ablation of atrial fibrillation/left atrial flutter/left atrial tachycardia - safety and effectivity (pilot study)
Recruiting
- Conditions
- I48.9Atrial fibrillation and atrial flutter, unspecified
- Registration Number
- DRKS00025560
- Lead Sponsor
- IVERSITÄTSKLINIKUM FREIBURGCampus Bad Krozingen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 112
Inclusion Criteria
(a) patients scheduled for catheter ablation treatment of atrial fibrillation, left atrial atrial flutter, or left atrial atrial tachycardia
(b) males and females at least 18 years of age.
Exclusion Criteria
a) Age <18 years
b) Contraindication to catheter ablation treatment or magnetic resonance imaging of the heart.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method a.Feasibility of transseptal puncture by pure X-ray-free 3D mapping control.<br>b.Occurrence of specific potential study-associated complications (vascular injury, pericardial effusion, pulmonary vein stenosis).<br>c.Total X-ray exposure time (in minutes and seconds) and X-ray dose (measured as dose area product) during the procedure.
- Secondary Outcome Measures
Name Time Method a.X-ray radiation duration and dose (as shown above) recorded for the procedural individual steps (3D mapping, transseptal puncture, and ablation). <br>b.Procedure duration<br>c.Ablation number, time<br>d.Recording of overall complication rate (including non-study-associated complications, intra- and post-procedural)<br>e.Recurrence at follow-up (3 and 6 months).