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Development and clinical validation of novel smart device to provide real-time ablation + tissue analysis through advanced 4D imaging to enable >90% success rate in Atrial Fibrillation treatment

Periodic Reporting for period 1 - VERAFEYE (Development and clinical validation of novel smart device to provide real-time ablation + tissue analysis through advanced 4D imaging to enable >90% success rate in Atrial Fibrillation treatment)

Reporting period: 2020-10-01 to 2021-09-30

Atrial Fibrillation (AFib) is a heart rhythm disorder or irregular heartbeat (arrhythmia) that can lead to blood clots, stroke and heart failure - and it is in fact almost as common as stroke and cancer in Europe1. Strokes caused by AFib are generally more severe and patients are twice as likely to die or suffer from greater neurological impairment compared to non-AFib strokes. AFib is caused by abnormal electrical activity in the heart and patients are highly symptomatic and resistant to medication with a dramatically increased risk to develop other diseases such as ischemic heart disease, chronic kidney disease or dementia and a significantly poorer quality of life. Today, there are more than 38.8 million people suffering from AFib globally, with 4.5 million new cases every year. By 2050, Europe is projected to have by far the greatest increase of AFib world-wide. Approximately 2% of people younger than 65 have AFib, while about 9% of people aged 65 and older have it, making AFib a time bomb for ageing populations.
Standard interventional treatment for AFib is through catheter ablation, a minimally invasive therapy which scars (destroys) small areas of heart tissue blocking the abnormal electrical pulses from entering the heart. However, electrophysiologists (i.e. doctors with a specialisation in abnormal heart rhythms) performing the procedure cannot visualize or assess the ablation lesions they have created (they use surrogate markers for successful ablation which can be unreliable and deeply complex) which means that doctors have no way of knowing if they have performed the procedure correctly (i.e. if they have successfully isolated and blocked the unwanted electrical signals or, instead, destroyed healthy tissue) and are largely ‘flying blind’. This leads to first-time success rates of catheter ablation being extremely low (53-61%) and patients returning to hospitals for repeat procedures (sometimes 3 or 4), weakening them further and adding more cost burden to overstretched healthcare systems globally.
In order to achieve isolation of unwanted electrical signals in the heart, ablated regions (lesions) must form a closed path around the target area and also be of the correct depth through the whole cardiac tissue along each point on this path. If both a closed path and depth are achieved during ablation, the target areas will be electrically isolated, thus stopping the disease. It was recently shown that freedom from AFib can be established in more than 90% of patients if both a closed path and depth are achieved. While the study imposed extensive clinical protocols not considered transferable into wide-scale adoption, this showed that catheter ablation can yield highly successful outcomes if applied correctly. However, if the ablated path is not closed (gaps in the path) or the ablation depth is not sufficient, unwanted electrical signals have shown to reconnect with a subsequent recurrence of AFib. In addition to the lack of specific ablation feedback, today’s systems to guide doctors during the ablation (Electroanatomical Mapping Systems - EAM) only provide 3D information with limited detail and precision, and the integration of highly-precise preoperative models (such as CT or MRI) is impaired by the challenging fusion of multiple 3D models, articulating the need for high-resolution intraoperative 4D-imaging ie. 3D imaging in real-time during the procedure, thus called ‘3D+time’/’3D+t’.
Despite the advancement of technologies in catheter and imaging tools and as shown by the wide range of explicit testimonies from cardiologist Key Opinion Leaders (KOLs) across Europe and the US, there is currently NO method of providing real-time analysis, 3D+t visualization and verification to the clinician that both a complete closed path and depth have been achieved. As a result, the outcome of AFib ablation using today’s techniques is not adequate for the fast growing number of patients, leading to unnecessary high re-intervention rates and costs.
The overarching aim of this 24-month EIC project is to develop the VERAFEYE system through market approval and thus ensure that a disruptive catheter-based imaging technology for the monitoring and verification of AFib ablations finds its way into clinical practice. To achieve this, a major development and validation effort is spread across 5 work packages grouped into project management, product development, regulatory pathways, pre-clinical and clinical validation, as well as manufacturing and supply chain setup.
• WP1 Project Management: During the first year of the project, the activities in the WP included recruitment of the team and resourcing of the project, project reporting, and overall project management as foundation for the overall work plan in the project.
• WP2 Product development: The reporting period was focussed on development iterations of the catheter to improve performance, and development multiple versions of a patient interface unit and system console towards. Components and system configurations were tested for each iterations in bench and ex-vivo. Software development for imaging, and image reconstruction as well as visualization focussed on the backend implementation.
• WP3 Quality and regulatory: System and market requirements were defined for the system along with risk analysis, as well as initialization of a QMS for medical device development. The regulatory strategy with a focus on USA and EU was further developed with outreach to clinical opinion leaders and considerations for clinical access in both major geographies. Technical development commenced as input for technical files.
WP4 Preclincal and Clinical: Preclinical studies were started for evaluation of the VERAFEYE system. Clinical site selection progressed with defined criteria and outreach to relevant PIs and sites, and the study design developed.
• WP5 Design, Manufacturing and Supply chain: System and subsystem requirements were detailed across all system components for both hardware and software, as input for design verification and validation of the VERAFEYE system. Verification and supply chain development commenced within internal team and external development partners.
The social benefits of VERAFEYE are unquestionable, as it contributes to providing improved treatment and thus direct benefit to patients suffering from AFib as the worlds most prominent heart rhythm disease.
Besides this, the society will benefit through VERAFEYE through lower healthcare expenditure and higher efficacy rates. Hospital providers can get access to more patients, and hospital staff can provide more successful treatment without the frustration of frequently repeating (the same) treatment for patients with recurring disease and the reputational stigma that tends to go with it in the eyes of patients.