The trial will compare the efficiency and efficacy of image-guided ventricular tachycardia (VT) ablation versus traditional, catheter-based techniques in cardiac arrhythmia patients
inHEART has begun enrolment of the inEurHeart clinical study. (Credit: Gerd Altmann from Pixabay)
US-based inHEART has begun the recruitment for an inEurHeart clinical study to compare the efficiency and efficacy of image-guided ventricular tachycardia (VT) ablation with traditional, catheter-based techniques in cardiac arrhythmia patients.
The company will recruit 112 patients in a blind randomised controlled trial (RCT) in 15 heart centres across four European countries by next year.
According to inHEART, the solution uses its segmentation algorithm to analyse CT or MR images to create interactive 3D models of the heart with anatomical details and a precise description of the arrhythmogenic areas in the scar.
It also offers extensive pre-procedural planning and sophisticated intraprocedural supervision.
All the details will be used by physicians in developing customised treatment plans and promote procedural efficiency, the firm said.
The solution is said to have demonstrated its potential to reduce VT procedure times by 60% and procedure success rates by 15% compared to the conventional approach.
It will also reduce the need for poorly tolerated ventricular arrhythmia for easy and simple procedures.
inHEART president and CEO Todor Jeliaskov said: “We are excited to begin enrollment of the RCT as part of the broader inEurHeart project.
“The inHEART solution is now commercially available in the US 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.”
The inEurHeart trial is part of a partnership between five organisations in France and the Netherlands to promote the use of artificial intelligence (AI) technologies in ordinary clinical practice so that more patients across the world can benefit from complicated cardiac therapy.
EIT Health (European Institute of Innovation and Technology) and the European Union are co-funding the inEurHeart initiative.
In July 2020, inHEART closed a round of €3.7m led by Elaia to accelerate commercial development and advance the development of its AI and numerical simulations of cardiac electrical activity.