MedPath

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

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
NameTimeMethod
Fluoroscopy timeProcedure time

To compare the fluoroscopy time between cryoballoon ablation with and without the use of 3D CT overlay

radiation exposureProcedure time

To compare the radiation exposure (DAP) between cryoballoon ablation with and without the use of 3D CT overlay

ContrastAmount 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
NameTimeMethod
Recurrenceone 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

Medisch Spectrum Twente
🇳🇱Enschede, OV, Netherlands

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.