A randomized comparison between 3 D CT overlay and conventional fluoroscopy to decrease contrast and radiation exposure during cryoballoon ablation for atrial fibrillatio

Completed

• Conditions: minimaal invasieve interventie; atrial fibrillation; 10007521

• Registration Number: NL-OMON37693
• Lead Sponsor: Medisch Spectrum Twente

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 94

Inclusion Criteria

All patients screened are accepted for PVI according to the current guidelines. Patients are candidates for enrolment if they have paroxysmal AF as defined in the guidelines

Exclusion Criteria

Persistent, long-standing persistent or permanent AF, left atrial diameter > 50 mm (measured in the parasternal long axis, as assessed with transthoracic echocardiography)and previous PVI ablation (epicardial or endocardial).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To compare the fluoroscopy time, radiation exposure (DAP) and amount of<br /><br>contrast medium between cryoballoon ablation with and without the use of 3D CT<br /><br>overlay</p><br>

Secondary Outcome Measures

Name	Time	Method
<p> The percentage of patients without a recurrence of AF, without AADs, within a<br /><br>follow-up period of at least 12 months after a stabilisation period of 90 days<br /><br>after the initial procedure. </p><br>