Improved procedural workflow for catheter ablation of paroxysmal AF with high-density mapping system and advanced technology: Rationale and study design of a multicenter international study

Francesco Solimene, Giuseppe Stabile, Pablo Ramos, Luca Segreti, Filippo Maria Cauti, Valerio De Sanctis, Ruggero Maggio, Javier Ramos-Maqueda, Lluis Mont, Vincenzo Schillaci, Maurizio Malacrida, Ignacio Garcia-Bolao, Francesco Solimene, Giuseppe Stabile, Pablo Ramos, Luca Segreti, Filippo Maria Cauti, Valerio De Sanctis, Ruggero Maggio, Javier Ramos-Maqueda, Lluis Mont, Vincenzo Schillaci, Maurizio Malacrida, Ignacio Garcia-Bolao

Abstract

Background: The antral region of pulmonary veins (PV)s seems to play a key role in a strategy aimed at preventing atrial fibrillation (AF) recurrence. Particularly, low-voltage activity in tissue such as the PV antra and residual potential within the antral scar likely represent vulnerabilities in antral lesion sets, and ablation of these targets seems to improve freedom from AF. The aim of this study is to validate a structured application of an approach that includes the complete abolition of any antral potential achieving electrical quiescence in antral regions.

Methods: The improveD procEdural workfLow for cathETEr ablation of paroxysmal AF with high density mapping system and advanced technology (DELETE AF) study is a prospective, single-arm, international post-market cohort study designed to demonstrate a low rate of clinical atrial arrhythmias recurrence with an improved procedural workflow for catheter ablation of paroxysmal AF, using the most advanced point-by-point RF ablation technology in a multicenter setting. About 300 consecutive patients with standard indications for AF ablation will be enrolled in this study. Post-ablation, all patients will be monitored with ambulatory event monitoring, starting within 30 days post-ablation to proactively detect and manage any recurrences within the 90-day blanking period, as well as Holter monitoring at 3, 6, 9, and 12 months post-ablation. Healthcare resource utilization, clinical data, complications, patients' medical complaints related to the ablation procedure and patient's reported outcome measures will be prospectively traced and evaluated.

Discussion: The DELETE AF trial will provide additional knowledge on long-term outcome following a structured ablation workflow, with high density mapping, advanced algorithms and local impedance technology, in an international multicentric fashion. DELETE AF is registered at ClinicalTrials.gov (NCT05005143).

Keywords: LumipointTM; antral potential; atrial fibrillation; catheter ablation; high-density mapping system; local impedance.

Conflict of interest statement

Maurizio Malacrida is an employee of Boston Scientific. The remaining authors have no conflict of interest to declare.

© 2022 The Authors. Clinical Cardiology published by Wiley Periodicals LLC.

Figures

Figure 1
Figure 1
DELETE AF study flowchart. 3D, three dimensional; DELETE AF, improveD procEdural workfLow for cathETEr ablation of paroxysmal atrial fibrillation; ECG, electrocardiogram; QOL, quality of life
Figure 2
Figure 2
DELETE AF procedural workflow. DELETE AF, improveD procEdural workfLow for cathETEr ablation of paroxysmal atrial fibrillation; PV, pulmonary vein; RF, radiofrequency
Figure 3
Figure 3
(A) The DELETE AF ablation protocol. Posterior view (left panel) and anterior view (right panel), using the RhythmiaTM mapping system. Point‐by‐point RF delivery created contiguous ablation spots encircling the PVs. The maximal interlesion distance between two neighboring lesions was set ≤6 mm and was automatically measured through the AutotagTM software. Power settings are set at the individual operator's discretion, within the range of 30–50 W, depending on the left atrial segment considered. In this example, power setting was 45 W at the posterior site (blue dots) and 50 W at anterior sites (red dots). (B) Examples of PVG (upper panel) and residual RAP (lower panel) detected through LumipointTM tool according to the procedural workflow. (C) After the antral lesion set was delivered, the OrionTM catheter was engaged in the PVs to assess circumferential luminal electrical activity and the LumipointTM tool was used sequentially on each PV component, to assess the presence of PVGs and RAPs and to characterize electrical propagation. In this example, antral isolation and electrical quiet were demonstrated in all the PVs after PV isolation and antral ablation. DELETE AF, improveD procEdural workfLow for cathETEr ablation of paroxysmal atrial fibrillation; PV, pulmonary vein; PVG, PV gap; RAP, residual potential within the antral scar; RF, radiofrequency

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Source: PubMed

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