Cavo-Tricuspid Isthmus Block Durability After Pulsed Electric Field Ablation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute for Clinical and Experimental Medicine
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
- 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
Trial design
Design model
Parallel
Treatments tested in this trial
Catheter ablation of cavotricuspid isthmus using flower configuration of the Farapulse catheter
Procedure/Surgerycatheter ablation
Catheter ablation of cavotricuspid isthmus using basket configuration of the Farapulse catheter
Procedure/SurgeryCatheter ablation of cavotricuspid isthmus using basket configuration of the Farapulse catheter
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Flower configurationActive comparator 1 intervention
Group B: Basket configurationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The acute durability of the CTI block
The primary goal of this study is to assess the acute durability of the CTI block when PEF energy is used. The bidirectional block on the CTI will be demonstrated with standard pacing manoeuvres (differential pacing from duodecapolar catheter and proximal CS).
Time frame
During the ablation procedureSecondary outcomes
1
The optimal waiting time for the conduction recovery after PEF CTI ablation
Second goal is to establish the optimal waiting time for the conduction recovery after PEF CTI ablation.
Time frame
During the procedure2
The utility of routine adenosine testing for dormant conduction on the CTI
Dormant conduction over the CTI will be assessed using an I.V. bolus of 12-18 mg of adenosine during continuous atrial pacing immediately after the confirmation of the CTI block and at the end of the procedure.
Time frame
During the ablation procedure.3
Concentration of plasma free haemoglobin
Plasma biomarker of hemolysis (free haemoglobin \[fHb\]) will be measured at two time points: before the procedure (T1) and after CTI isolation before LA ablation (T2). Levels of fHb will be compared among the study groups.
Time frame
During the ablation procedure4
The presence of the coronary vasospasm
The surface electrocardiogram (ECG) will be analyzed across all 12 leads to evaluate for the presence of ST segment elevation (i.e. signs of the coronary vasospasm) after the CTI ablation.
Time frame
During the ablation procedureSponsors and contacts
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Source ClinicalTrials.gov