Actively Recruiting
Cavo-Tricuspid Isthmus Block Durability After Pulsed Electric Field Ablation
Led by Institute for Clinical and Experimental Medicine · Updated on 2024-11-15
150
Participants Needed
1
Research Sites
67 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Cavo-Tricuspid Isthmus Block Durability After Pulsed Electric Field Ablation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with paroxysmal atrial fibrillation undergoing pulmonary vein isolation by pulsed electric field energy with documented typical atrial flutter or patients with persistent atrial fibrillation planned for CTI ablation as part of a complex procedure
- Age 18 years or older at study enrollment
- Signed informed consent
You will not qualify if you...
- Left atrial diameter greater than 65 mm (measured in parasternal long-axis view)
- History of cavo-tricuspid isthmus ablation
- History of cardiac valve surgery
- Significant valvular defect
- Age below 18 years
- Pregnancy or breastfeeding
- Any disease with life expectancy less than 1 year
- Uncorrected congenital heart disease or valvular obstruction
- Active myocarditis
- Untreated hypothyroidism or hyperthyroidism
- Recipient of major organ transplant (lung, liver, heart)
- HIV positivity with survival expectancy less than 5 years due to HIV
- Chronic dialysis treatment
- Unwillingness to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute for Clinical and Experimental Medicine
Prague, Prague, Czechia, 14200
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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