Atrial Fibrillation
Conditions
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.
Interventions
DEVICECryoablation
Pulmonary vein isolation using cryoablation
Sponsors
Medisch Spectrum Twente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Netherlands
Outcome results
None listed