Feasibility Study for Optically Guided Radiofrequency Ablation Catheter (NEOVIEW)
March 25, 2025 updated by: Medlumics
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
4
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Prague, Czechia, 150 30
- Na Homolce Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Radiofrequency ablation patients
Single-Arm study, all patients included will undergo RF ablation using AblaView® Ablation Catheter
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
at completion of the procedure with AblaView® Ablation Catheter
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of the technique on occurence of adverse effects (Safety and Tolerability)
Time Frame: 30 days after the procedure
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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)
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30 days after the procedure
|
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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)
|
30 days after the procedure of ablation with AblaView® Ablation Catheter is completed
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Stepan Kralovec, Authorised representative in the Czech Republic
- Principal Investigator: Petr Neuzil, MD, Na Homolce Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 24, 2017
Primary Completion (Actual)
July 24, 2017
Study Completion (Actual)
July 28, 2017
Study Registration Dates
First Submitted
June 22, 2018
First Submitted That Met QC Criteria
July 5, 2018
First Posted (Actual)
July 18, 2018
Study Record Updates
Last Update Posted (Actual)
March 28, 2025
Last Update Submitted That Met QC Criteria
March 25, 2025
Last Verified
July 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-001890-34 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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