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Feasibility Study for Optically Guided Radiofrequency Ablation Catheter

NCT03589742 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2025-03-28

No results posted yet for this study

Summary

Clinical study intended to evaluate the feasibility of a new irrigated RF ablation catheter that allows the physiologist to perform a regular RF ablation procedure while it is being monitored through an imaging technique known as Optical Coherence Reflectometry (OCR). This technique is based upon the use of infrared light; it is innocuous for the human body and allows for the detection of the contact between the catheter tip with the tissue besides the lesion formation during the Radiofrequency (RF) application as the OCR technique is able to distinguish between ablated tissue and healthy tissue. Both features are able to provide a better control of the ablation procedure, which may become in a better clinical result in cardiac ablation procedures, especially in Atrial Fibrillation cases.

Conditions

Interventions

DEVICE

AblaView® Ablation Catheter

The AblaView® Ablation Catheter is a regular RF ablation catheter with the same physical characteristics and the same biocompatible materials, with an 8 French (2.66 mm) sheath and 180º deflection angle. The tip of the catheter has 15 holes distributed around it where the irrigation will be delivered into the patient's blood. The front irrigation hole will deliver at the same time the infrared light for the OCR system.

Sponsors & Collaborators

  • Medlumics

    lead INDUSTRY

Principal Investigators

  • Stepan Kralovec · Authorised representative in the Czech Republic

  • Petr Neuzil, MD · Na Homolce Hospital

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-24
Primary Completion
2017-07-24
Completion
2017-07-28

Countries

  • Czechia

Study Locations

More Related Trials

Entities

Diseases

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 NCT03589742 on ClinicalTrials.gov