RecruitingNot ApplicableNCT06691074

Cavo-Tricuspid Isthmus Block Durability After Pulsed Electric Field Ablation

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


Sponsor

Institute for Clinical and Experimental Medicine

Enrollment

150 participants

Start Date

Sep 16, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • 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

Exclusion Criteria14

  • \- LA diameter \> 65 mm (measured in the parasternal long-axis view)
  • History of CTI ablation in the past
  • History of cardiac valve surgery
  • Significant valvular defect
  • Age below 18 years
  • Pregnancy, breastfeeding
  • Any disease with a life expectancy \<1 year
  • Uncorrected congenital heart disease or valvular obstruction
  • Active myocarditis
  • Untreated hypothyroidism or hyperthyroidism
  • Recipient of any major organ transplant (e.g., lung, liver, heart)
  • HIV positivity with a survival expectancy of less than five years due to HIV
  • Chronic dialysis treatment
  • Unwillingness to participate.

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Interventions

PROCEDURECatheter ablation of cavotricuspid isthmus using flower configuration of the Farapulse catheter

catheter ablation

PROCEDURECatheter ablation of cavotricuspid isthmus using basket configuration of the Farapulse catheter

Catheter ablation of cavotricuspid isthmus using basket configuration of the Farapulse catheter


Locations(1)

Institute for Clinical and Experimental Medicine

Prague, Prague, Czechia

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NCT06691074


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