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An Innovative Image Guided Radiofrequency Ablation System to treat Atrial Fibrillation

Periodic Reporting for period 1 - ABLAVIEW (An Innovative Image Guided Radiofrequency Ablation System to treat Atrial Fibrillation)

Reporting period: 2019-05-01 to 2020-04-30

Atrial Fibrillation (AF) is the most common type of cardiac arrhythmia. More than 35 millions people worldwide suffer from AF, and the prevalence of the disease is expected to increase as the number of people over the age of 65 continues to expand. AF increases the risk of stroke by a factor 5 and is a major healthcare problem in the developed world. AF is a supraventricular tachycardia presenting irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related complications. It is the most common type of cardiac arrhythmia.
The treatment goals for AF include regaining a normal heart rhythm and regulating the heart rate. Although commonly used, available drug therapies to control heart rhythm in AF have significant shortcomings, with more than half of patients’ refractory to treatment after one year. Antiarrhythmic compounds further suffer from serious side effects and reduced quality of life for patients, including pro-arrhythmic behaviour and non-cardiovascular toxicity. Cardiac ablation therapy is the only current therapy with healing potential for this type of arrhythmia. This procedure isolates and prevents irregular electrical currents originate mainly in the pulmonary veins (conveying blood the lungs and the heart). Although catheter ablation is becoming a first-line therapy for some patients, the results are not yet fully satisfactory. Indeed, success measured as freedom of AF at one-year follow up was been found to be as low as 41% in a broad European registry across technologies. Additionally, patient safety is still a concern with this therapy; with serious adverse events being reported in 1 out of 40 patients.

Therapy success depends on the clinician’s ability to fully ablate tissue through the heart wall without missing any gaps between ablation points that could result in AF recurrence. Currently clinicians can neither visualize the quality of the contact of their catheter with the tissue wall, nor its stability, nor quality of the ablation in real time. Having the capability to directly assess lesion creation, would enable to clinicians to create safer, more durable, and continuous lesions to treat AF and prevent its recurrence.
To address these needs, MedLumics has developed the solution called AblaView® which is a first optically guided radiofrequency (RF) ablation system for the treatment of atrial fibrillation. AblaView’s optical sensor in the tip of the catheter ablates the cardiac tissue and isolate the defective tissue and provides direct lesion assessment to determine ablation quality “inside the heart in real time”. It operates through a catheter with integrated Optics system that delivers infrared light to measure the change in polarization state of tissue being ablated directly as it happens in real time. The loss of birefringence provides proof that the tissue was completely ablated.
MedLumics’ AblaView catheter will provide the clinicians with direct, real-time information on lesion assessment visualization, contact assessment and lesion monitoring during the ablation process reducing the treatment complexity and improving arrythmia ablation procedures. Prior to ablation, as part of a pre-treatment strategy, the AblaView™ technology can differentiate the tissue conditions between healthy and ablated tissue, as well as scar or tissue disorders associated to its fiber arrangement. This detection capability can be especially useful in involving patients at their initial treatment for AF as it can optically guide a continuous and complete lesion efficiently for suppressing AF.
This project encompasses the optimisation of a 360-degree optical sensing coverage of catheter surroundings. This is achieved by miniaturised photonic components that direct and focus the light at 90 degrees, 45 degrees and forward looking directions; fully covering the space around the device tip and enabling the multi-view catheter.

The project structure starts with the System Integration featuring the Ablaview Catheter, Console and Software/GUI. That supposes the completion of the technical development of the first fully working prototype ready to conduct in-vitro and animal work. The initial design and process development has been completed using the new platform in the tip, as well as the required changes in the catheter shaft and handle, allowing all the fibers being threaded and assembled properly.

Full system integration work has been performed allowing the different parts of the product to interface to each other to realize the tissue sensing functionality and meet the technical specification. The Ablaview Console has been adapted to the new platform including new opto-electrical components such as optical switches, phase switches and splitters. The acquisition step has been optimized to the new frequency ranges and signal intensities. The software architecture has been re-design considering the new hardware components and algorithms.

Pre-clinical functional verification was achieved through the creation of a first in vitro lesion library with optical multifibre RF ablation catheter prototype. This in vitro library established a robust relationship between proprietary real-time measurement of birefringence and the progression of the ablation lesion depth, this helped to guide the electrophysiologists during the first series of in vivo experiments that validated the in vitro model. These 2 steps are the basis of the Good Laboratory Practices experiments to be performed on frozen-design catheter, console and graphic user-interface
AblaVAblaView is taking a breakthrough innovation further towards the market, by moving the concept from the current proof of principle stage to actual clinical validation. This is done by overcoming the technological disadvantages of current prototypes, incorporating more advanced OCT technology and carrying out all the testing, documentation and manufacturing transfer activities needed to be ready for clinical trials and submission of the technical documentation to BSI, Notified Body of MedLumics on the way to CE Certification of the AblaView System. The project represents an innovation that is of value globally but is especially relevant for the future of European healthcare systems, where arrhythmias in general and AF in particular are pathologies linked to sedentary lifestyles and ageing populations.
AblaView® will enable MedLumics to create a breakthrough solution in device-based arrhythmia management, with the potential for global leadership and a significant expansion in the AF population. The company will start clinical trials to demonstrate the safety and performance of AblaView®, and ultimately its effectiveness in improving clinical practice. The work will involve patients to be recruited in European electrophysiology centres including 1-year follow-up and including a 3-month control. These results, supported by prior preclinical work (in vitro laboratory model and animal experimentation) carried out with AblaView®, will be the basis for filing for Class III Medical Device CE Mark, which will be the cornerstone of the future growth of the company.
The proposed activities in this project will take the AblaView from the TRL7 to TRL 9, with a complete and qualified system ready to reach the market in Europe by the end of the project.
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