NCT03589742

Feasibility Study for Optically Guided Radiofrequency Ablation Catheter

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Medlumics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This feasibility study intended for the evaluation of the technique in humans prior to a Safety and efficacy study based on the non-inferiority of AblaView® Ablation Catheter against a control device. Thus, no randomization has been decided and no blinding has been considered necessary. The primary clinical endpoints of this investigation are as follows: * Primary Endpoint 1: Feasibility of the technique in humans. Validate that the technique is able to provide real time image of the change in the optical properties of the heart tissue during the ablation procedure. * Primary Endpoint 2: Safety of the technique, major complications incidence (equal to or below regular procedure incidence of serious adverse events of 5%) 30 days after the procedure (ictus, cardiac tamponade, major hemorrhage, esophageal lesion, death) * Secondary Endpoint 1: Safety of the device, complications incidence within the 30 days after the procedure (Detachable parts, irrigation leak, malfunction of the handling/steering, break of electrical parts and "pop" occurrence) The Principal Investigator will be responsible for the evaluation of the Primary Endpoint 1, providing feedback from every patient and describing the feasibility of the technique according to his criteria. The Primary Endpoint 2 will be measured according to the clinical practice guidance for the evaluation of: ictus, cardiac tamponades, major hemorrhage, esophageal lesion and death, and will be recorded right after the procedure and in the patient record for the 30 days follow up visit. The Secondary Endpoint 1 will be measured according to the Principal investigator's criteria and the assessment of the Medlumics technician for the evaluation of detachable parts, irrigation leaks, malfunction of the handling/steering, break of electrical parts and "pop" occurrence), and will be recorded right after the procedure and in the patient record for the 30 days follow up visit. Subjects will only be replaced if the recruitment period is not ended and the eligible number of patients is under 15, they will not be replaced if they get excluded after the beginning of the study.

Conditions

• Atrial Fibrillation
• Atrial Flutter

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-06-24
• Primary completion: 2017-07-24
• Completion: 2017-07-28
• First posted: 2018-07-18
• Last updated: 2025-03-28

Locations

1 site across 1 country: Czechia