French privately-held medical device company InHeart has started a controlled trial for its AI-enabled digital twin of the heart.

The first-of-its-kind study will compare image-guided ventricular tachycardia (VT) ablation with conventional, catheter-based strategies to evaluate efficiency and efficacy of image-guided procedures in cardiac arrythmia patients.

The company delivers AI-enabled, digitally-rendered 3D models of the heart. It has begun enrolment of the InEurHeart clinical study; a multicentre, prospective, blind randomised controlled trial (RCT) to compare the efficiency and efficacy of image-guided VT ablations to conventional, catheter-based methods.

The study aims to enrol 112 patients in 15 heart centres across four European countries over the next year.

“The InEurHeart clinical trial is a critical step in the scientific evaluation of image-guided ablations and we are excited to be enrolling patients in this study,” said Thomas Deneke, director of the heart centre at Rhön Klinkum in Bad Neustadt, Germany. “The additional information provided by InHeart has already been instrumental in determining treatment strategies for some of our most challenging VT cases and we look forward to the findings of this work to further inform the future of image-guided therapy.”

The technology aims to address many of the difficulties with conventional VT ablation with its proprietary segmentation algorithm that analyses CT or MR images to create interactive 3D models of the heart with unprecedented anatomical details, including a precise description of the arrhythmogenic areas in the scar. This additional information allows physicians to optimise treatment strategies based on each patient’s unique cardiac anatomy and supports detailed, pre-procedural planning and intraprocedural guidance with integration into all major electroanatomic mapping (EAM) systems. This helps physicians develop individual treatment strategies and supports procedural efficiencies, allowing for greater focus on the execution of the therapy during the procedure.

The InEurHeart RCT is a component of a larger innovation collaboration between five organisations in France and the Netherlands to advance the use of artificial intelligence (AI) tools in everyday clinical practice to make complex cardiac therapies accessible to more patients around the world. The project is funded by the European Institute of Innovation & Technology and co-funded by the European Union.

“We are excited to begin enrolment of the RCT as part of the broader InEurHeart project,” said Todor Jeliaskov, CEO of InHeart. “This is now commercially available in the USA and EU and, with data from this trial, we will build broad product adoption to bring the most advanced cardiac care to patients around the world.”

Cardiovascular disease is a leading cause of global mortality, accounting for almost 17 million deaths annually, or 30% of all deaths worldwide. It is estimated that 40 to 50% of all cardiovascular deaths are sudden cardiac deaths (SCDs) and roughly 80% of SCDs are caused by ventricular arrythmias, including ventricular tachycardia and ventricular fibrillation.

Treatments for VT include implantation of cardioverter defibrillators (ICD), anti-arrhythmic drug treatment and catheter ablation, but these therapies are limited by incomplete efficacy, unfavourable side effects and procedural risks.

Success rates for conventional VT ablation remain low and variable due to the complexity of the arrhythmia and the inaccurate and incomplete identification of ablation targets.

Early clinical evaluations of the InHeart technology have shown a potential to reduce VT procedure times by 60% compared with the conventional approach, from five hours to less than two hours. Shorter procedures are typically associated with better safety and patient experience.

Using the digital twin also means there is no need to induce poorly tolerated ventricular arrhythmia, contributing to easier and simpler procedures. In addition, these evaluations have demonstrated the potential for image-guided ablations to improve procedure success rates, as compared with the conventional approach, from 60 to 75%.

See also blog post on digital twin for the heart.