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AblaView® Unipolar PFA OCR-guided Feasibility Study - First in Man

NCT06700226 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-03-28

No results posted yet for this study

Summary

Exploratory Clinical Investigation to evaluate the feasibility and safety of the AblaView® Unipolar Percutaneous Ablation Irrigated Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation using Polarization Sensitive Optical Coherence Reflectometry (PS-OCR) to guide delivery of Pulsed Field Ablation (PFA) lesions - First in Man

Conditions

  • Paroxysmal AF

Interventions

DEVICE

AblaView® Unipolar PFA System

Patients with symptomatic paroxysmal atrial fibrillation will be treated with the AblaView® Unipolar PFA System system to achieve electrical isolation of the pulmonary veins. The AblaView® Unipolar PFA Catheter is a regular PFA irrigated catheter. The tip of the catheter has 7 holes distributed around that deliver at the same time irrigation and near infrared light for the OCR system, which will be processed and interpreted by the Console.

Sponsors & Collaborators

  • Clinical Accelerator

    collaborator INDUSTRY

  • Medlumics

    lead INDUSTRY

Principal Investigators

  • Atul Verma, MD, PhD · Division of Cardiology, McGill University Health Centre, McGill University, Montreal, Quebec, Canada

  • Raphael Martins, MD, PhD · University of Rennes, CHU Rennes, Rennes, France

  • Askar Sabirov, MD · Cardiology Department, AKFA Medline University Hospital, Tashkent, Uzbekistan

  • Giorgi Papiashvili, MD, PhD · Israeli-Georgian Medical Research Clinic Healthycore and European University, Tbilisi; Georgia.

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-08
Primary Completion
2024-12-20
Completion
2025-02-28

Countries

  • Uzbekistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06700226 on ClinicalTrials.gov