Proton Particle Therapy for Cardiac Arrhythmia

Cardiac Arrhythmia Clinical Trial

Official title: Proton Particle Therapy for Cardiac Arrhythmia Extracorporeal Energy Source Ablation of Cardiac Tissue: A First Stage Early Feasibility Study

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia

• NCT number: NCT04392193
• Study type: Interventional
• Source: Mayo Clinic
• Status: Completed
• Phase: N/A
• Start date: March 19, 2021
• Completion date: March 9, 2024