A randomized comparison between 3 D CT overlay and conventional fluoroscopy to decrease contrast and radiation exposure during cryoballoon ablation for atrial fibrillation

A randomized comparison between 3 D CT overlay and conventional fluoroscopy to decrease contrast and radiation exposure during cryoballoon ablation for atrial fibrillation - CAFE

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37693

Enrollment

Registered

2012-07-16

Start date

2012-10-24

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

minimaal invasieve interventie atrial fibrillation

Interventions

Cryoablation using a balloon with standard fluoroscopy versus cryoablation with 3D CT overlay

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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)and previous PVI ablation (epicardial or endocardial).

Design outcomes

Primary

Measure	Time frame
To compare the fluoroscopy time, radiation exposure (DAP) and amount of contrast medium between cryoballoon ablation with and without the use of 3D CT overlay	—

Secondary

Measure	Time frame
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

Source: NL-OMON (via WHO ICTRP)