A new treatment approach for difficult-to-treat heart rhythm problems, specifically for patients with Ventricular Tachycardia (VT) that hasn’t responded to other treatments, is being tested. Known as STereotactic Arrhythmia Radioablation (STAR), this treatment adapts a method from cancer therapy to target heart tissue non-invasively. To expand this promising treatment, more clinical and technical data is needed from a larger number of patients.
In the initial phase of the STOPSTORM project, the consortium of over 30 centers was formed, and the groundwork was laid for data collection. This included aligning legal and logistical requirements across countries, establishing the STAR registry infrastructure, and designing initial clinical trials. Early studies and surveys revealed significant differences in STAR practices across sites, setting a baseline for future standardization efforts.
In the second phase, prospective clinical trials for STAR began in each participating country, and data entry into the registry started. The first guidelines on STAR were developed and shared through conferences and publications. Additionally, a patient advisory board was established to guide patient-centered resources, and more European centers joined as external partners to increase patient recruitment. This phase concluded with a seamless transition of the project’s coordinating center, maintaining steady progress despite minor delays.
In the third period we caught up with most delays after the completion of the transition of the coordinating centre and the on-boarding of all new External Registry Partner to register STAR patients into the STOPSTORM database. The data collection of the observation cohort (patient treated before the start of the STOPSTORM consortium) has been concluded and data can be analysed soon. The data collection of the harmonized cohort (patient treated after the start of the STOPSTORM consortium) is ongoing in almost 40 centres and overall, more than 300 patients have already been registered in the STOPSTORM database at the end of the third period (recruitment goal reached). Additionally, numerous additional project analyses are in preparation adding to the already well-published project with over 15 direct STOPSTORM and over 60 STAR related manuscripts from the many consortium centres. Furthermore, the consortium generated comprehensive high quality benchmark documents for radiotherapy (auto)-contouring and treatment planning studies and for invasive and non-invasive electro-anatomical mapping as well as standardized workflows for accurate target delineation and transfer to radiotherapy planning systems, and a clinical consensus statement by the European Heart Rhythm Society (EHRA) providing practical advice for the implementation of STAR. A clinical consensus statement by the European Society for Radiation Oncology (ESTRO) is additionally in preparation. Finally, the planned interim analysis highlighted that STAR reduces the number of VT episodes as well as the VT burden. It was also shown that many adverse events were unlikely to be STAR-related. Lastly, motion and its dosimetric effect have similar magnitudes between treatment setups and were found to be patient-specific. These and other results from ethical research and from meta-analyses were disseminated largely and discussed with the several boards of the consortium (e.g. patient advisory board, external advisory board, and external observer groups).
