First-in-Human Results, Europace 2025

Evidence first.

The AblaView® first-in-human study confirmed the system’s ability to detect during ablation whether the procedure will be ineffective: 100% specificity for durable PFA at three-month follow-up. Peer-reviewed in Europace.

The device presented is under preclinical/clinical investigation. It is not FDA approved nor CE labelled.

Primary FIM Result, Europace February 2025
100%
Specificity for durable PFA lesion prediction at three-month follow-up.
First-in-human single-centre feasibility study. 10 patients. No hemolysis. No neurovascular complications. Peer-reviewed publication in Europace, 5 February 2025.
0
Device-Related SAEs
No hemolysis. No neurovascular complications reported in the FIM cohort.
10
Patients, FIM Cohort
First-in-human feasibility of unipolar PFA with integrated PS-OCR guidance.
25TB+
Proprietary PS-OCR Dataset
Accumulated across twelve years of catheter-focused work. Approximately 2.7 TB clinical (Y14 and Y06) and ~22.4 TB preclinical. Trains every AI module.
Europace
Peer-Reviewed
27(2):euaf009. 5 February 2025. IF 6.1.
Trial Registry & Publication Record
Registry
ClinicalTrials.gov, NCT06700226 →
AblaView® Unipolar PFA OCR-guided Feasibility Study, First in Man
Study type: First-in-human feasibility, single-arm • Sponsor: Medlumics / AblaView® • Registry last updated 2025-03-28
Primary Publication
AblaView® Unipolar PFA OCR-guided Feasibility Study, First-in-Human Results. Europace. 2025 Feb 5;27(2):euaf009.
DOI: 10.1093/europace/euaf009 • PMID: 39824175

Endpoints, statistical analysis plan, and agreement analysis versus reference methods are described in the peer-reviewed publication and registry record. Full protocol and analysis artifacts are available in the data room under NDA.

Co-authors and investigators

Drawn from the peer-reviewed FIM (Europace, 2025) and preclinical (Circulation, 2024) publications.

Co-author on the AblaView® first-in-human Europace publication, February 2025. Proctor during the first-in-human cases.

Prof. Atul Verma, MD
Director of Cardiology, McGill University Health Centre.

Co-author on the AblaView® first-in-human Europace publication, February 2025. Proctor during the first-in-human cases.

Prof. Raphaël Martins, MD, PhD
Cardiac Electrophysiologist, CHU Rennes / University of Rennes.

Lead author on the AblaView® PS-OCR preclinical study published in Circulation, 2024. Directs the Preclinical Cardiovascular Lab at Sunnybrook.

Dr. Maria Terricabras, MD
Cardiac EP and Director, Preclinical Cardiovascular Lab, Sunnybrook / University of Toronto.

The full author list, principal investigator, proctors and contributing institutions are recorded in the peer-reviewed publications linked below.

Lesion Durability Prediction

Comparative accuracy in predicting chronic lesion durability at 3-month remap

AblaView® specificity for durable PFA lesion prediction at three-month follow-up reported in Europace, February 2025. Force and impedance comparators are indicative ranges drawn from the published literature on chronic lesion durability.

Regulatory posture

Investigational device, active programme.

The AblaView® system is under preclinical and clinical investigation. It is not FDA approved nor CE labelled. Programme detail (standards mapping, QMS state, notified body, pre-submission outcomes) is shared with qualified partners under NDA.

  • ✓ FIM published. Single-centre first-in-human feasibility study (n=10) peer-reviewed in Europace, 2025. 100% specificity for durable PFA lesion prediction at three-month follow-up. No device-related SAEs.
  • ✓ Preclinical evidence. 860+ preclinical ablations (GLP and non-GLP) paired with histology. Animal-to-human PS-OCR signal correlation demonstrated.
  • ✓ Active regulatory programme. FDA pre-submission and CE pathway work in progress under an established medical-device QMS. Detailed milestones depend on regulator feedback and are not committed publicly.
  • ✓ Advisory clinical role. AI outputs are advisory; treatment decisions remain with the electrophysiologist.
Peer-reviewed publications

On the record.

Only peer-reviewed journal articles are listed. Reprint requests honoured within publisher policy.

Europace • Volume 27, Issue 2 • 5 February 2025
AblaView® Unipolar PFA OCR-guided Feasibility Study, First-in-Human Results
Europace. 2025 Feb 5;27(2):euaf009 • DOI: 10.1093/europace/euaf009 • PMID: 39824175
Circulation: Arrhythmia and Electrophysiology • 2024
Preclinical PS-OCR-guided ablation in a porcine model: lesion characterisation and histological correlation
Lead author Dr. Maria Terricabras and AblaView preclinical co-authors.

Conference abstracts, posters, presentations, white papers and technical briefs are not listed on the public site. They are made available to qualified partners on request once their compliance with publisher and regulatory policy has been verified.

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