Feasibility Study for Optically Guided Radiofrequency Ablation Catheter (NEOVIEW)

• ClinicalTrials.gov Identifier: NCT03589742
• Recruitment Status: Terminated
• First Posted: July 18, 2018
• Last Update Posted: July 18, 2018
• Sponsor: Medlumics
• Information provided by (Responsible Party): Medlumics

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Atrial Fibrillation; Atrial Flutter	Device: AblaView® Ablation Catheter	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 4 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: Feasibility Study for Optically Guided Radiofrequency Ablation Catheter
• Actual Study Start Date: June 24, 2017
• Actual Primary Completion Date: July 24, 2017
• Actual Study Completion Date: July 28, 2017

Arms and Interventions

Arm

Intervention/treatment

Experimental: Radiofrequency ablation patients; Single-Arm study, all patients included will undergo RF ablation using AblaView® Ablation Catheter

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.

Outcome Measures

Primary Outcome Measures :

1. Feasibility of the technique in humans [ Time Frame: at completion of the procedure with AblaView® Ablation Catheter ]
   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. This change will be analyzed intraoperative because untreated myocardial tissue has a high level of cellular organization, which exhibits a significant phase retardation between orthogonal polarization states, leading to reflect polarized light. But birefringence property disappears by applying RF power during time on the same location, because the fibers are denaturalized. This optical change can be measured to provide a reliable marker for cellular and subcellular organization to estimate lesion formation in real time

Secondary Outcome Measures :

1. Incidence of the technique on occurence of adverse effects (Safety and Tolerability) [ Time Frame: 30 days after the procedure ]
   major complications incidence (equal to or below regular procedure incidence of serious adverse events of 5%) within the 30 days after the procedure (ictus, cardiac tamponade, major hemorrhage, esophageal lesion, death)
2. Validation of the usability and design of the medical device [ Time Frame: 30 days after the procedure of ablation with AblaView® Ablation Catheter is completed ]
   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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Czechia

Na Homolce Hospital

Prague, Czechia, 150 30

Sponsors and Collaborators

Medlumics

Investigators

• Study Director: Stepan Kralovec; Authorised representative in the Czech Republic
• Principal Investigator: Petr Neuzil, MD; Na Homolce Hospital

More Information

Publications:

Herranz D, Lloret J, Jiménez-Valero S, Rubio-Guivernau JL, Margallo-Balbás E. Novel catheter enabling simultaneous radiofrequency ablation and optical coherence reflectometry. Biomed Opt Express. 2015 Aug 7;6(9):3268-75. doi: 10.1364/BOE.6.003268. eCollection 2015 Sep 1.

• Responsible Party: Medlumics
• ClinicalTrials.gov Identifier: NCT03589742
• Other Study ID Numbers: 2016-001890-34; 2016-001890-34 ( EudraCT Number )
• First Posted: July 18, 2018
• Last Update Posted: July 18, 2018
• Last Verified: July 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Medlumics:

Atrial Fibrillation; Atrial Flutter; Radiofrequency Ablation; Pulmonary Vein Isolation; Catheter; AblaView Ablation Catheter; Atrioventricular node

Additional relevant MeSH terms:

Atrial Fibrillation; Atrial Flutter; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes