Systematic Assessment of the Acute Cavo-Tricuspid Isthmus Block Durability After Pulsed Electric Field Ablation

Status: Recruiting
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study seeks to assess the acute durability of the CTI block when PEF energy is used. Second goal is to establish the optimal waiting time for the conduction recovery after PEF CTI ablation and to assess the utility of routine adenosine testing for dormant conduction. Moreover, this study aims to investigate the differences in acute efficacy and adverse events (hemolysis, coronary vasospasm) between the two available configurations (basket or flower) of the pentaspline Farawave catheter (Farapulse-Boston Scientific Inc, USA).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• patients with paroxysmal AF undergoing PVI by PEF energy with documented typical atrial flutter or patients with persistent AF in whom catheter ablation of CTI is planned as a part of a complex procedure

• Age ≥ 18 years at the time of study enrollment

• Signed informed consent

Time Frame
Start Date: 2024-09-16
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 150
Treatments
Active_comparator: Flower configuration
Ablation of the CTI using a Farapulse catheter in flower configuration
Active_comparator: Basket configuration
Ablation of the CTI using a Farapulse catheter in basket configuration
Sponsors
Leads: Institute for Clinical and Experimental Medicine

This content was sourced from clinicaltrials.gov