Cavo-Tricuspid Isthmus Block Durability After Pulsed Electric Field Ablation (NCT06691074) | Clinical Trial Compass
RecruitingNot Applicable
Cavo-Tricuspid Isthmus Block Durability After Pulsed Electric Field Ablation
Czechia150 participantsStarted 2024-09-16
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* \- 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The acute durability of the CTI block
Timeframe: During the ablation procedure
Trial details
NCT IDNCT06691074
SponsorInstitute for Clinical and Experimental Medicine