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

Medisch Spectrum Twente30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Atrial Fibrillation

Interventions

CryoablationDEVICE

Pulmonary vein isolation using cryoablation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Medisch Spectrum Twente

Enschede, Overijssel, Netherlands

Outcomes

Primary Outcomes

Fluoroscopy time

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

Time frame: Procedure time

radiation exposure

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

Time frame: Procedure time

Contrast

To compare the amount of contrast medium between cryoballoon ablation with and without the use of 3D CT overlay

Time frame: Amount of contrast during procedure

Secondary Outcomes

Recurrence

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.

Time frame: one year

Data from ClinicalTrials.gov

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