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

Medisch Spectrum Twente

Status: Terminated

Conditions: Atrial Fibrillation

Treatments: Device: Cryoablation

Study type: Interventional

Funder types: Other

Identifiers

NCT06701383

P12-16 (Other Identifier)

NL39065.044.11

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Standard fluorscopy

Active Comparator group

Description:

Cryoablation using a balloon with standard fluoroscopy

Treatment:

Device: Cryoablation

3D CT overlay

Experimental group

Description:

Cryoablation using a balloon with 3D CT overlay

Treatment:

Device: Cryoablation