An interventional study of Proton Particle Therapy in Cardiac Arrhythmia, sponsored by Konstantinos Siontis. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-01-15.
Sponsored by Konstantinos Siontis · Not applicable, Interventional, and Device feasibility
Researchers are gathering information on the safety and effectiveness of proton radiation therapy in reducing the number of ventricular tachycardia (VT) episodes in subjects who continue to experience VT despite treatment with an implantable cardioverter defibrillator (ICD) and undergoing a previous catheter ablation.
Proton therapy has been approved by the U.S. Food and Drug Administration (FDA) for cancer patients, including tumors in the heart, but not for treating heart rhythm disorders. The use of proton radiation therapy to treat heart rhythm disorders including VT and ventricular fibrillation (VF) is new and investigational; however, the FDA has approved proton therapy to treat abnormal rhythm disorders for this study. The development of a proton radiation therapy approach could be of substantial value in providing alternative therapy to either drug therapy or catheter-based ablation. With appropriate development, this therapy may be successful in the primary or secondary elimination of arrhythmias.
Participants will be followed at 1 and 2 weeks, 1, 3, 6, 12 and 24-month intervals following treatment throughout the trial.
Participant involvement will last approximately two years from the time of the proton radiation therapy procedure or until the last subject enrolled completes a 24 month follow-up.
915 studies on the registry are indexed under Arrhythmias, Cardiac; 234 are open to participants now.
This study's enrollment of 8 is below the median of 97 across 443 interventional studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →This is the only study on the registry with Konstantinos Siontis as lead sponsor.
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Exclusion Criteria:
Subjects who have an ICD with recurrent VT, VF, or VT storm who have failed one prior standard catheter-based ablation after device implantation, will subsequently undergo particle-based extracorporeal ablation.
Radiation: Proton Particle Therapy
Proton therapy will be delivered in a single fraction using the Probeat-V system
Mortality
Total number of subject deaths
Time frame: 2 years
Implantable Cardioverter Defibrillator (ICD) Shocks
Total number of recurrent ICD shocks
Time frame: 2 years
Recurrent Ventricular Tachycardia (VT)
Total number of recurrent VT requiring repetitive antitachycardia pacing (ATP) device therapy
Time frame: 2 years
Cardiac Arrest
Total number of cardiac arrests
Time frame: 2 years
Plan to share: No
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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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