Cavo-Tricuspid Isthmus Block Durability After Pulsed Electric Field Ablation
Recruiting now · Not applicable
Conditions studied: Flutter, Atrial, Cavotricuspid Isthmus Dependent Right Atrial Flutter, Catheter Ablation
In brief
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).
Key facts
- Study ID
- NCT06691074
- Run by
- Institute for Clinical and Experimental Medicine
- People needed
- 150
- Starts
- 2024-09-16
- Expected to finish
- 2025-12-31
- Last updated by the study team
- 2024-11-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- - 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.
Where it is running
- Institute for Clinical and Experimental Medicine — Prague, Prague, Czechia (enrolling)
Full record on ClinicalTrials.gov
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