Feasibility Study for Optically Guided Radiofrequency Ablation Catheter

NCT03589742 | Completed

• 1 other identifier: 2016-001890-34
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Atrial Flutter

Keywords

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

Outcome Measures

Primary Outcomes (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. 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 Outcomes (2)

• Incidence of the technique on occurence of adverse effects (Safety and Tolerability)

  30 days after the procedure

• Validation of the usability and design of the medical device

  30 days after the procedure of ablation with AblaView® Ablation Catheter is completed

Study Arms (1)

Radiofrequency ablation patients

EXPERIMENTAL

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

Device: AblaView® Ablation Catheter

Interventions

AblaView® Ablation Catheter DEVICE

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.

Radiofrequency ablation patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medlumics: lead

Study Sites (1)

Na Homolce Hospital

Prague, 150 30, Czechia

Location

Related Publications (1)

• Herranz D, Lloret J, Jimenez-Valero S, Rubio-Guivernau JL, Margallo-Balbas 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.

  PMID: 26417499 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stepan Kralovec

  Authorised representative in the Czech Republic

  STUDY DIRECTOR

• Petr Neuzil, MD

  Na Homolce Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2018
• First Posted: July 18, 2018
• Study Start: June 24, 2017
• Primary Completion: July 24, 2017
• Study Completion: July 28, 2017
• Last Updated: March 28, 2025

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)