Feasibility Study for Optically Guided Radiofrequency Ablation Catheter (NEOVIEW)

Medlumics

Status

Completed

Conditions

Atrial Flutter

Atrial Fibrillation

Treatments

Device: AblaView® Ablation Catheter

Study type

Interventional

Funder types

Industry

Identifiers

NCT03589742

2016-001890-34 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

4 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients over 18 years old.
Patients with confirmed paroxysmal Atrial Fibrillation, showing symptoms, with a documented episode within the last year, where at least 1 antiarrhythmic drug treatment have failed, and considered as candidates for cardiac ablation after electrophysiologist diagnose
Patients with confirmed Atrial Flutter, showing symptoms, with a documented episode within the last year, and considered as candidates for cardiac ablation after electrophysiologist diagnose
All patients will be properly informed, accepting to participate in the study voluntarily by signing the informed consent form.

Exclusion criteria

Patients that have been subject of a former RF ablation procedure weather for Atrial Fibrillation or Atrial Flutter
Patients with significant structural cardiopathy (ventricular dysfunction with Left Ventricle Ejection Fraction (LVEF)<35%, with severe valvulopathies, congenital cardiopathies)
Severe dilatation of the left atria (>5 cm)
Acute coronary syndrome within the last year prior to enrolment
Any hemorrhagic ictus or ischemic ictus within the last year prior to enrolment
Active hemorrhage
Anticoagulant contraindications
Patients with severe comorbidities that may reduce their life expectancy (<1 year) or personal circumstances that may difficult the clinical follow up
Inability to obtain informed consent