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Evaluating the Durability of Cavo-Tricuspid Isthmus Block After Pulsed Electric Field Ablation Comparing Flower and Basket Farapulse Catheter Configurations for Atrial Flutter Treatment
Led by Institute for Clinical and Experimental Medicine · Updated on 2024-11-15
150
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
This research aims to evaluate the immediate effectiveness and durability of the cavo-tricuspid isthmus CTI block using pulsed electric field PEF energy in patients with atrial fibrillation AF and typical atrial flutter. The study will also determine the best waiting time to detect recovery of conduction after PEF CTI ablation and assess the usefulness of routine adenosine testing for dormant conduction. Additionally, it compares two catheter configurations, basket and flower, to study differences in acute success and side effects like hemolysis and coronary vasospasm. Participants undergo catheter ablation of the CTI using either the flower or basket configuration of the Farapulse catheter in a randomized 11 assignment. Ablations are performed during atrial pacing under anesthesia with intracardiac echocardiography guidance. Patients receive sublingual nitrates before ablation, and sequential PEF applications are delivered until CTI block is achieved. Adenosine testing for dormant conduction and monitoring of conduction recovery times are performed during the procedure. Blood samples to measure plasma biomarkers are collected before and after CTI isolation. Throughout the study, patients are monitored using catheters in the heart, electrocardiograms, and intracardiac imaging. Researchers measure the acute durability of the CTI block, time to conduction recovery, presence of dormant conduction via adenosine testing, plasma hemoglobin levels, and coronary vasospasm occurrence. The study includes 150 patients aged 18 and older, with follow-up during the ablation procedure to assess these outcomes under continuous observation. The total participation time corresponds to the duration of the ablation procedure and associated assessments.
CONDITIONS
Brief Title
Cavo-Tricuspid Isthmus Block Durability After Pulsed Electric Field Ablation
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