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

NCT06700226 | Completed

• 1 other identifier: 48437
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Atrial Fibrillation; PFA; Optically guided

Outcome Measures

Primary Outcomes (2)

• Realtime predictability of PFA ablation lesion chronicity

  Feasibility: 3-month Validation: Predictability Assessment by PS-OCR and PFA Lesions continuity and chronicity at 3-month remapping. Evaluation of the predictability of chronicity of ablation lesions in terms of Accuracy, Specificity and Sensitivity

  Up to 3 months

• Safety Acute

  Serious procedure- and device-related adverse events. Serious adverse events, and their relatedness to the AblaView Unipolar PFA System or procedure will be adjudicated by the Clinical Events Committee. The sites are required to report all adverse events.

  Up to 3 months

Secondary Outcomes (7)

• Procedure Parameters

  The day of the procedure

• Per procedure (Ablation/remapping) optical parameters

  The day of procedure

• Procedure Validation

  The day of the procedure

• Recurrence

  Up to 3 months

• Improvement in the Quality of Life

  At 3 months

Study Arms (1)

Patients treated under PFA

EXPERIMENTAL

Single-Arm study, all patients included will undergo PFA using AblaView® Unipolar PFA System

Device: AblaView® Unipolar PFA System

Interventions

AblaView® Unipolar PFA System DEVICE

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.

Patients treated under PFA

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A subject will be eligible for study participation if he/she meets the following criteria:
• Symptomatic Paroxysmal Atrial Fibrillation (PAF) with at least one documented episode in the 6 previous months (according to the ESC 2020 guidelines and AHA/ACC 2023 Guidelines). Documentation may include ECG, trans-telephonic monitor (TTM), Holter monitor (HM), or telemetry strips.
• Eligible for de novo catheter intra-atrial ablation (e.g., pulmonary vein isolation).
• Eligible for Transesophageal echocardiography (TEE) or Intracardiac Echocardiography (ICE) (AHA/ACC/HRS 2014 Guidelines for AF Management pertaining to anticoagulation at the time of cardioversion and the update in 2023) performed within 24 hours of the ablation procedure in all patients with AF of 48 hours duration or of unknown duration if adequate systemic anticoagulation has not been maintained for at least 1 month prior to AF ablation.
• Antero-posterior left atrial diameter ≤ 5.5 cm as documented by transthoracic echocardiography (TTE) or computed tomography (CT) within 3 months prior to the procedure.
• Age ≥ 18 years and ≤ 85 years on the day of enrollment.
• Voluntarily accepts participation after being duly informed of the ablation procedure and its risks, as well as the remapping procedure planned three months later, by signing the informed consent form.

You may not qualify if:

• Persistent or long-standing persistent AF.
• Arrhythmia due to reversible causes, including thyroid disorders, acute alcohol intoxication, electrolyte disorders, and other major surgical procedures in the preceding three months.
• Myocardial infarction (MI), acute coronary syndrome percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within the preceding 3 months.
• Antero-posterior Left atrial diameter \> 5.5 cm
• Previous left atrial ablation procedures, either surgical or catheter ablation.
• Prior left atrial intervention, surgical procedure, or incision with resulting scar, including AF ablation or LAA closure.
• Previous tricuspid or mitral valve replacement or repair.
• Presence of an implantable cardiac defibrillator (ICD).
• Heart disease for which corrective surgery is anticipated within 6 months.
• Active systemic infection.
• Bleeding diathesis or suspected procoagulant state.
• Contraindication to long-term antithromboembolic therapy.
• Presence of a condition that precludes appropriate vascular access.
• Estimated glomerular filtration rate (eGFR) \< 50 mL/min/1.73 m2 or has ever received dialysis renal failure requiring dialysis.
• Body mass index \> 40.

Sponsors & Collaborators

• Medlumics: lead
• Clinical Accelerator: collaborator

Study Sites (1)

Ezgu Niyat

Tashkent, Uzbekistan

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Atul Verma, MD, PhD

  Division of Cardiology, McGill University Health Centre, McGill University, Montreal, Quebec, Canada

  STUDY CHAIR

• Raphael Martins, MD, PhD

  University of Rennes, CHU Rennes, Rennes, France

  STUDY CHAIR

• Askar Sabirov, MD

  Cardiology Department, AKFA Medline University Hospital, Tashkent, Uzbekistan

  PRINCIPAL INVESTIGATOR

• Giorgi Papiashvili, MD, PhD

  Israeli-Georgian Medical Research Clinic Healthycore and European University, Tbilisi; Georgia.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-center, open, single-arm, exploratory clinical investigation. This clinical investigation will include up to 10 subjects in 1 site. All subjects treated will be followed up for 3 months or up to re-treatment

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 21, 2024
• Study Start: September 8, 2024
• Primary Completion: December 20, 2024
• Study Completion: February 28, 2025
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

UZ (1)