AITAF

Ablation Index in standard vs. high power radiofrequency ablation for Typical Atrial Flutter: a randomized study

A randomized controlled trial will be conducted to evaluate the efficacy of Ablation Index-guided high power – short duration (HPSD) ablation compared to conventional power settings in Cavotricuspid Isthmus (CTI) dependent atrial flutter. Participants will be randomized to receive either AI-guided HPSD ablation at 50 Watts or conventional power settings at 30 Watts. Both arms will use the Carto 3D mapping system and the QDOT MICRO ablation catheter (Biosense Webster). An anatomically contiguous line will be created with <6mm inter-lesion distance. After a standardized wait time of 30 minutes, ablation success will be assessed.

Enrolment Criteria

Inclusion
- Clinically determined by a cardiac electrophysiologist to have had at least one episode of CTI-dependent atrial flutter
- Clinically determined by a cardiac electrophysiologist to likely benefit from standalone CTI ablation
- For this to be their first CTI ablation attempt
- Able and willing to comply with all protocol requirements
- Agree to and sign patient Informed Consent Form (ICF)
- Be 18 years of age or older
Exclusion
- Previous CTI ablation
- Adult congenital heart disease, including Ebstein’s anomaly
- Previous surgery involving the tricuspid valve and atrium including cannulation scars for cardiopulmonary bypass
- Pediatric population age <18
- Women who are pregnant or breastfeeding.
- Active enrollment in another investigational study involving a drug or device.
- A requirement for additional procedures in the same setting. Such as EP study and ablation of other induced arrhythmias since these prolong secondary endpoints such as procedure time and RF time
- Patients on anti-arrhythmic drugs (AADs) such as flecainide, sotalol, or amiodarone should have their AAD stopped 3 days prior, and not be restarted after the procedure
- Patients under General Anesthetic (GA)
- Patients with sufficient baseline cognitive impairment to be unable to answer a post-procedure survey or consent
Previous ablations, other than for CTI flutter, are acceptable.