Randomized Comparison Between 3 D CT Overlay and Conventional Fluoroscopy to Decrease Contrast and Radiation Exposure During Cryoballoon Ablation for Atrial Fibrillation
- 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
- 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
- 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.
Related Research Topics
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Trial Locations
- Locations (1)
Medisch Spectrum Twente
🇳🇱Enschede, OV, Netherlands
Medisch Spectrum Twente🇳🇱Enschede, OV, Netherlands