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Paroxysmal AFNCT06700226

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

A study testing AblaView® Unipolar PFA System in people with Paroxysmal AF, run by Medlumics at 1 site in Uzbekistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Paroxysmal AF
What is being tested?
AblaView® Unipolar PFA System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUzbekistan
Study dates
8 Sep 2024to 28 Feb 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 27Show fewer
  • 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.
  • Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with premedication.
  • Contraindication to general anesthesia (GA)
  • Contraindications to computed tomography.
  • Severe pulmonary disease (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms.
  • Positive pregnancy test results for female subjects with childbearing potential.
  • Has known pulmonary vein stenosis, or other anatomic or concomitant conditions that, in the investigator's opinion, could limit the subject's ability to participate in the study, comply with follow-up requirements, or impact the scientific soundness of the study results.
  • In the opinion of the Principal Investigator (PI), it is unlikely to survive the clinical investigation plan with a follow-up period of twelve months.
  • Clinically significant psychological conditions that in the physician's opinion would prohibit the subject's ability to meet the protocol requirements.
  • Currently participating in another clinical investigation or participating in a clinical investigation that may interfere with this clinical investigation within 30 days prior to screening.
  • Severely compromised LVEF (LVEF <40%)
  • The presence of intracardiac thrombus (e.g., LA), myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation.
  • Severe mitral regurgitation

Trial locations and contacts

1 site in 1 country.

Uzbekistan1 site

  • Ezgu Niyat

    Tashkent

Other trials in Uzbekistan

About this study

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

Read the detailed description

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
Being tested
AblaView® Unipolar PFA System
Keywords
Atrial Fibrillation, PFA, Optically guided
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AblaView® Unipolar PFA SystemDevice

    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.

Study groups in NCT06700226
Study groupRoleWhat they receive
Patients treated under PFAExperimentalSingle-Arm study, all patients included will undergo PFA using AblaView® Unipolar PFA System
Receives: Device: AblaView® Unipolar PFA System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Up to 3 months

  2. 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.

    Measured: Up to 3 months

Secondary outcomes (7)

  1. Procedure Parameters

    • Skin-to-skin procedural time, minutes
    • Device left atrial dwell time, minutes
    • Time between first and last application, minutes
    • Fluoroscopy time during procedure, minutes
    • Total amount of PFA energy delivered in, joules.
    • Number of applications per targeted vein and/or isolation and for complete procedure, number

    Measured: The day of the procedure

  2. Per procedure (Ablation/remapping) optical parameters

    • Detection of optical signals to evaluate contact and birefringence in the left atria, yes or no
    • Detection and quantification of changes in birefringence during ablation, in %
    • Detection of gaps in the continuous ablation/isolation lines during ablation procedure, yes or no

    Measured: The day of procedure

  3. Procedure Validation

    Acute Validation (20 to 30) min at least after the completion of each line/isolation by Electrical and optical isolation of targeted pulmonary veins (PVs), yes or no

    Measured: The day of the procedure

  4. Recurrence

    Recurrence or new occurrence of arrhythmias controlled by Holter 48-hrs and by TTM weekly and triggered by symptoms.

    Measured: Up to 3 months

  5. Improvement in the Quality of Life

    • Atrial Fibrillation Effect on Quality-of-Life (AFEQT) score difference between baseline and at 3 month
    • European Quality of Life-5 Dimensions (EQ-5D-5L) score difference between baseline and at 3 month in total and for mobility, self-care, usual activities, pain/discomfort and anxiety/depression

    Measured: At 3 months

  6. Safety at 1 month

    MACE (30d)

    Measured: At 1 month

  7. Safety at 3 months

    Occurence of Atrial/Ventricular Arrhythmias, Stroke, HF

    Measured: Between 1 month and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2024
  2. Study start8 Sep 2024
  3. Primary completion20 Dec 2024
  4. Study completion28 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Model description
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
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06700226
Sponsor's protocol ID
48437
Status last verified
Mar 2025
First submitted
14 Nov 2024
Last updated
28 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Small feasibility studies of device products

Questions about this trial

What is this clinical trial studying?

A study testing AblaView® Unipolar PFA System in people with Paroxysmal AF, run by Medlumics at 1 site in Uzbekistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Uzbekistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Realtime predictability of PFA ablation lesion chronicity (time frame: Up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06700226.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.

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