Randomized Comparison Between 3 D CT Overlay and Conventional Fluoroscopy to Decrease Contrast and Radiation Exposure During Cryoballoon Ablation for Atrial Fibrillation

Not Applicable

Terminated

• Conditions: Atrial Fibrillation

• Registration Number: NCT06701383
• Lead Sponsor: Medisch Spectrum Twente

Brief Summary

Cryoablation using a balloon is an effective therapy for paroxysmal atrial fibrillation (AF), however associated with significant amounts of radiation exposure and contrast medium use. A new imaging technique (3D CT overlay) could reduce radiation exposure and contrast medium use significantly.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Primary Completion: 2014-05
• Study Completion: 2015-05
• Status Verified: 2024-11
• Study First Submitted: 2024-11-20
• Study First Submitted QC: 2024-11-20
• Last Update Submitted: 2024-11-20
• Study First Posted: 2024-11-22
• Last Update Posted: 2024-11-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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)
• Previous PVI ablation (epicardial or endocardial).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fluoroscopy time	Procedure time	To compare the fluoroscopy time between cryoballoon ablation with and without the use of 3D CT overlay
radiation exposure	Procedure time	To compare the radiation exposure (DAP) between cryoballoon ablation with and without the use of 3D CT overlay
Contrast	Amount of contrast during procedure	To compare the amount of contrast medium between cryoballoon ablation with and without the use of 3D CT overlay

Secondary Outcome Measures

Name	Time	Method
Recurrence	one year	The percentage of patients without a recurrence of AF, without AADs, within a follow-up period of at least 12 months after a stabilisation period of 90 days after the initial procedure.

Trial Locations

Locations (1)

Medisch Spectrum Twente; 🇳🇱 Enschede, OV, Netherlands