Ablation Index in Standard vs. High Power Radiofrequency Ablation for Typical Atrial Flutter: A R… (NCT06406686) | Clinical Trial Compass
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Ablation Index in Standard vs. High Power Radiofrequency Ablation for Typical Atrial Flutter: A Randomized Study (AITAF)
Canada50 participantsStarted 2024-06-03
Plain-language summary
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. The primary outcome is total radiofrequency ablation time. Secondary outcomes include procedural time, fluoroscopy time, safety outcomes, and 3-month freedom from recurrence. It is our expectation that HPSD will result in a shorter primary outcome.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Clinically determined by a cardiac electrophysiologist to have had at least one episode of CTI dependent atrial flutter
✓. Clinically determined by a cardiac electrophysiologist likely to 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 criteria
✕. 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
✕. 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