Accuracy and clinical outcomes of CARTOSOUND compared to electro-anatomical mapping for atrial fibrillation ablation: A randomised controlled study.
Not Applicable
Completed
- Conditions
- Drug refractory atrial fibrillationCardiovascular - Other cardiovascular diseases
- Registration Number
- ACTRN12612000089831
- Lead Sponsor
- niversity of Adelaide
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Drug refractory atrial fibrillation ablation patients presenting for an atrial fibrillation ablation procedure
Exclusion Criteria
Age < 18 years,
Pregnancy,
Thrombus in left atrium on trans-esophageal echocardiogram,
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total procedural X-ray time from the point at which venous access is gained until the removal of catheters.[At the end of the clinical procedure]
- Secondary Outcome Measures
Name Time Method 3D navigational accuracy as assessed by 1) distance to the map surface and 2) distance from the pulmonary vein ostia.[At the end of 3D map creation, before the beginning of the ablation procedure];Arrhythmia free clinical success (without anti-arrhythmic drugs) using a combination of patient symptoms and/or atrial fibrillation (AF) detected on 7 day Holter monitoring at 3 monthly intervals.[3, 6, 9, 12 months after the procedure];Peri-procedural and long term complications<br>eg.<br>Bleeding complications at catheter access site<br>Pericardial effusions detected via echocardiography<br>Pulmonary vein stenoses (via cardiac magnetic resonance imaging at 6 months)<br>Embolic events detected via symptoms and consequent clinical investigations (eg. computed tomography scan)[3, 6, 9, 12 months after the procedure]