Assessing the durability of a heart procedure using pulsed electric field energy
Systematic Assessment of the Acute Cavo-Tricuspid Isthmus Block Durability After Pulsed Electric Field Ablation
This study is testing if a new heart procedure using pulsed electric field energy can effectively block a specific area in the heart for people with atrial flutter and how long to wait before checking if the treatment worked.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institute for Clinical and Experimental Medicine Government |
| Locations | 1 site (Prague, Prague) |
| Trial ID | NCT06691074 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of pulsed electric field (PEF) energy in creating a durable block at the cavo-tricuspid isthmus (CTI) during catheter ablation for atrial flutter. It aims to determine the optimal waiting time for conduction recovery post-ablation and the utility of adenosine testing for dormant conduction. The study will involve 150 patients undergoing pulmonary vein isolation (PVI) and will compare two configurations of the Farapulse catheter to assess differences in efficacy and adverse events. Procedures will be conducted under general anesthesia or deep sedation with continuous anticoagulation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with paroxysmal atrial fibrillation undergoing PVI or those with persistent atrial fibrillation requiring CTI ablation.
Not a fit: Patients with significant heart conditions, prior CTI ablation, or other serious health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and durable treatments for patients with atrial flutter.
How similar studies have performed: While there have been studies on radiofrequency ablation, the use of pulsed electric field energy for CTI block durability is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Prague, Prague
- Institute for Clinical and Experimental Medicine — Prague, Prague, Czechia (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.