0
Device-Related SAEs
No hemolysis. No neurovascular complications reported in the FIM cohort.
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
SAFETY
COHORT
DATA
PEER-REVIEWED
TRIAL REGISTRY
100% specificity for durable PFA prediction.
Measured at three-month follow-up in the first-in-human single-centre feasibility study. 10 patients. No hemolysis. No neurovascular complications. Peer-reviewed publication in Europace, 5 February 2025.
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
27(2):euaf009
5 February 2025. IF 6.1.
ClinicalTrials.gov, NCT06700226 →
AblaView® Unipolar PFA OCR-guided Feasibility Study, First in Man. First-in-human feasibility, single-arm. Sponsor: Medlumics / AblaView®. Registry last updated 2025-03-28. Endpoints, statistical analysis plan, and agreement analysis versus reference methods are described in the peer-reviewed publication and registry record (see Publications below). Full protocol and analysis artifacts are available in the data room under NDA.
CO-AUTHORS AND INVESTIGATORS
EUROPACE • 2025 • FIRST-IN-HUMAN
EUROPACE • 2025 • FIRST-IN-HUMAN
CIRCULATION • 2024 • PRECLINICAL
Named on the record.
Drawn from the peer-reviewed FIM (Europace, 2025) and preclinical (Circulation, 2024) publications.
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.
Co-author on the AblaView® first-in-human Europace publication, February 2025. Proctor during the first-in-human cases.
Dr. Maria Terricabras, MD
Cardiac EP and Director, Preclinical Cardiovascular Lab, Sunnybrook / University of Toronto.
Lead author on the AblaView® PS-OCR preclinical study published in Circulation, 2024. Directs the Preclinical Cardiovascular Lab at Sunnybrook.
The full author list, principal investigator, proctors and contributing institutions are recorded in the peer-reviewed publications linked below.
LESION DURABILITY PREDICTION
Comparative accuracy at 3-month remap.
Accuracy in predicting chronic lesion durability at the three-month remap, by guidance signal.
| GUIDANCE SIGNAL | SPECIFICITY FOR DURABLE LESION PREDICTION | SOURCE |
|---|---|---|
| Force | ~60% | Indicative range drawn from the published literature on chronic lesion durability. |
| Impedance | ~75% | Indicative range drawn from the published literature on chronic lesion durability. |
| AblaView® | 100% | Durable PFA lesion prediction at three-month follow-up, reported in Europace, February 2025. |
ANIMATED VIEW OF THE TABLE ABOVE. ABLAVIEW: EUROPACE, FEBRUARY 2025. COMPARATORS: LITERATURE RANGES. INVESTIGATIONAL DEVICE.
REGULATORY POSTURE
FIM PUBLISHED
PRECLINICAL EVIDENCE
REGULATORY PROGRAMME
CLINICAL ROLE
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.
First-in-human, peer-reviewed
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.
Histology-paired ablations
860+ preclinical ablations (GLP and non-GLP) paired with histology. Animal-to-human PS-OCR signal correlation demonstrated.
Active on both pathways
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 outputs only
AI outputs are advisory; treatment decisions remain with the electrophysiologist.
PEER-REVIEWED PUBLICATIONS
EUROPACE • VOLUME 27, ISSUE 2 • 5 FEBRUARY 2025
CIRCULATION: ARRHYTHMIA AND ELECTROPHYSIOLOGY • 2024
On the record.
Only peer-reviewed journal articles are listed. Reprint requests honoured within publisher policy.
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
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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