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 fibrillation; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12612000089831
• Lead Sponsor: niversity of Adelaide

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-18
• Last Update Posted: 2020-01-13

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]