Clinical trial NCT06700226: AblaView® Unipolar PFA OCR-guided Feasibility Study - First in Man
Official title: AblaView® Unipolar PFA OCR-guided Feasibility Study - First in Man
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paroxysmal AF
Keywords: Atrial Fibrillation
PFA
Optically guided
Lead sponsor: Medlumics
Sponsor class: INDUSTRY
Collaborators: name: Clinical Accelerator
First posted: 2024-11-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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
Primary purpose: DEVICE_FEASIBILITY

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

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

Eligibility criteria: Inclusion Criteria:

A subject will be eligible for study participation if he/she meets the following criteria:

1. 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.
2. Eligible for de novo catheter intra-atrial ablation (e.g., pulmonary vein isolation).
3. 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.
4. 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.
5. Age ≥ 18 years and ≤ 85 years on the day of enrollment.
6. 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.

Exclusion Criteria:

1. Persistent or long-standing persistent AF.
2. Arrhythmia due to reversible causes, including thyroid disorders, acute alcohol intoxication, electrolyte disorders, and other major surgical procedures in the preceding three months.
3. Myocardial infarction (MI), acute coronary syndrome percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within the preceding 3 months.
4. Antero-posterior Left atrial diameter \> 5.5 cm
5. Previous left atrial ablation procedures, either surgical or catheter ablation.
6. Prior left atrial intervention, surgical procedure, or incision with resulting scar, including AF ablation or LAA closure.
7. Previous tricuspid or mitral valve replacement or repair.
8. Presence of an implantable cardiac defibrillator (ICD).
9. Heart disease for which corrective surgery is anticipated within 6 months.
10. Active systemic infection.
11. Bleeding diathesis or suspected procoagulant state.
12. Contraindication to long-term antithromboembolic therapy.
13. Presence of a condition that precludes appropriate vascular access.
14. Estimated glomerular filtration rate (eGFR) \< 50 mL/min/1.73 m2 or has ever received dialysis renal failure requiring dialysis.
15. Body mass index \> 40.
16. Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with premedication.
17. Contraindication to general anesthesia (GA)
18. Contraindications to computed tomography.
19. 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.
20. Positive pregnancy test results for female subjects with childbearing potential.
21. 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.
22. 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.
23. Clinically significant psychological conditions that in the physician's opinion would prohibit the subject's ability to meet the protocol requirements.
24. 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.
25. Severely compromised LVEF (LVEF \<40%)
26. The presence of intracardiac thrombus (e.g., LA), myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation.
27. Severe mitral regurgitation

Primary outcomes:
measure: Realtime predictability of PFA ablation lesion chronicity
timeFrame: Up to 3 months
measure: Safety Acute
timeFrame: Up to 3 months
Secondary outcomes:
measure: Procedure Parameters
timeFrame: The day of the procedure
measure: Per procedure (Ablation/remapping) optical parameters
timeFrame: The day of procedure
measure: Procedure Validation
timeFrame: The day of the procedure
measure: Recurrence
timeFrame: Up to 3 months
measure: Improvement in the Quality of Life
timeFrame: At 3 months
measure: Safety at 1 month
timeFrame: At 1 month
measure: Safety at 3 months
timeFrame: Between 1 month and 3 months
Other outcomes:
Locations:
city: Tashkent
country: Uzbekistan
facility: Ezgu Niyat
Study officials:
affiliation: Division of Cardiology, McGill University Health Centre, McGill University, Montreal, Quebec, Canada
name: Atul Verma, MD, PhD
role: STUDY_CHAIR
affiliation: University of Rennes, CHU Rennes, Rennes, France
name: Raphael Martins, MD, PhD
role: STUDY_CHAIR
affiliation: Cardiology Department, AKFA Medline University Hospital, Tashkent, Uzbekistan
name: Askar Sabirov, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Israeli-Georgian Medical Research Clinic Healthycore and European University, Tbilisi; Georgia.
name: Giorgi Papiashvili, MD, PhD
role: STUDY_CHAIR
References: