CompletedNot Applicable

Feasibility Study for Optically Guided Radiofrequency Ablation Catheter

Czechia4 participantsStarted 2017-06-24

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Feasibility of the technique in humans

Timeframe: at completion of the procedure with AblaView® Ablation Catheter

Trial details

NCT IDNCT03589742

SponsorMedlumics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-07-24