NCT06700226

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Medlumics · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Conditions

• Paroxysmal AF

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-09-08
• Primary completion: 2024-12-20
• Completion: 2025-02-28
• First posted: 2024-11-21
• Last updated: 2025-03-28

Locations

1 site across 1 country: Uzbekistan