Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2025 Feb 5;27(2):euaf009.
doi: 10.1093/europace/euaf009.

First-in-human trial of atrial fibrillation ablation using real-time tissue optical assessment to predict pulsed field lesion durability

Raphael P Martins  1 , Giorgi Papiashvili  2   3 , Askar Sabirov  4 , Sherzod Sabirov  5 , David Herranz  6 , Christophe Bailleul  6 , Atul Verma  7
Affiliations
Clinical Trial

First-in-human trial of atrial fibrillation ablation using real-time tissue optical assessment to predict pulsed field lesion durability

Raphael P Martins et al. Europace. .

Abstract

Aims: Loss of bipolar electrograms immediately after pulsed field ablation (PFA) makes lesion durability assessment challenging.

Objective: The aim of this trial (NCT06700226) was to evaluate a novel ablation system that can optically predict lesion durability by detecting structural changes in the tissue during ablation.

Methods and results: Patients with paroxysmal atrial fibrillation underwent pulmonary vein isolation (PVI) using PFA (AblaView®, MedLumics). Using polarization-sensitive optical coherence reflectometry (PS-OCR), reflective characteristics of myocardial tissue and visualization of real-time contrast between healthy tissue and ablated tissue using a drop in tissue birefringence (BiR) was assessed. Wide antral PVI was performed using single point irrigated PFA (unipolar, 1800V, 3 trains, 21 s). Remapping was performed at 3 months. Primary efficacy outcome was the ability of PS-OCR to predict lesion durability at 3-month remapping. Serious adverse events were recorded. Ten patients were included. In total, 38/40 PVs could be isolated with the system. The mean drop of BiR was 17.3 ± 11.5%. Dragging across the ablation lines showed a persistent drop in BiR. During the remap procedures (8/10 patients ablated only with PFA), 12 PVs (37.5%) were found to be electrically reconnected. The mean loss of BiR during all PFA for durable lesions was 20.9%, while only 10.1% BiR loss was observed during the index ablation for reconnected areas (P < 0.001). None of the points with ≥17% loss of birefringence was found to be reconnected.

Conclusion: This first-in-human study supports the use of real-time drop in tissue BiR for lesion assessment and durability during PFA delivery, and its procedural safety.

Keywords: Ablation; Atrial fibrillation; Birefringence; Polarization sensitive optical coherence reflectometry; Pulsed field ablation.

PubMed Disclaimer

Conflict of interest statement

Conflict of interest: D.H. and C.B. are employees of MedLumics; A.V. reports grants/advisory from Medtronic, Biosense Webster, Abbott, and advisory from MedLumics and Adagio Medical; R.P.M. reports grants/advisory from Biosense Webster, Abbott, and advisory from MedLumics; G.P. reports advisory fees from MedLumics, A.S. and S.S. report clinical investigators’ fees from MedLumics.

Figures

Graphical Abstract
Graphical Abstract
Figure 1
Figure 1
Components of the Medlumics AblaView system.
Figure 2
Figure 2
(A) Catheter-Tissue stable contact image. (B) Catheter-Tissue unstable contact image influenced by the mechanical movement of the lungs when breathing. PS-OCR, polarization-sensitive optical coherence reflectometry.
Figure 3
Figure 3
Violin plots comparing the percentage of birefringence loss (A) and abatement of bipolar electrograms (B) for durable and reconnected lesions. EGM, electrogram; PFA, pulsed field ablation.
Figure 4
Figure 4
Example of birefringence loss in a patient depicting durable pulmonary vein isolation during remapping. A high loss of birefringence was observed in almost all the ablation points. LIPV, left inferior pulmonary vein; LSPV, left superior pulmonary vein; RIPV, right inferior pulmonary vein; RSPV, right superior pulmonary vein.
Figure 5
Figure 5
Example of birefringence loss in a patient with pulmonary vein reconnection during remapping. A gap was found in the anterior part of the RSPV (red arrow), where a weak loss of birefringence was observed. LIPV, left inferior pulmonary vein; LSPV, left superior pulmonary vein; RIPV, right inferior pulmonary vein; RSPV, right superior pulmonary vein.
Figure 6
Figure 6
Baseline and 3-month follow-up of the AFEQT score for each patient.
See this image and copyright information in PMC

References

    1. Joglar JA, Chung MK, Armbruster AL, Benjamin EJ, Chyou JY, Cronin EM et al. 2023 ACC/AHA/ACCP/HRS guideline for the diagnosis and management of atrial fibrillation: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation 2024;149:e1–156. - PMC - PubMed
    1. Reddy VY, Mansour M, Calkins H, d’Avila A, Chinitz L, Woods C et al. Pulsed field vs conventional thermal ablation for paroxysmal atrial fibrillation: recurrent atrial arrhythmia burden. J Am Coll Cardiol 2024;84:61–74. - PubMed
    1. Dello Russo A, Compagnucci P, Anselmino M, Schillaci V, Campanelli F, Ascione MR et al. Pulsed field vs very high-power short-duration radiofrequency ablation for atrial fibrillation: results of a multicenter, real-world experience. Heart Rhythm 2024;21:1526–36. - PubMed
    1. Boersma L, Andrade JG, Betts T, Duytschaever M, Pürerfellner H, Santoro F et al. Progress in atrial fibrillation ablation during 25 years of Europace journal. Europace 2023;25:euad244. - PMC - PubMed
    1. Ekanem E, Neuzil P, Reichlin T, Kautzner J, van der Voort P, Jais P et al. Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study. Nat Med 2024;30:2020–9. - PMC - PubMed

Publication types

MeSH terms

Grants and funding