Proton Particle Therapy for Cardiac Arrhythmia
Proton Particle Therapy for Cardiac Arrhythmia
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.
Inclusion Criteria:

 -  Prior myocardial infarction or non-ischemic disease resulting in myocardial
 dysfunction

 -  A left ventricular ejection fraction (EF) <50%

 -  An implanted ICD device as secondary prevention for monomorphic VT/VF. This includes
 patients who receive a device for primary prevention and then have recurrent sustained
 monomorphic VT or VT

 -  Have failed a prior catheter-based ablation for VT/VF after device implantation or
 have a contraindication to repeat ablation and and have failed reasonable drug options
 over the 3 months prior to consideration of particle therapy

 -  Repeat ablation from an epicardial venue in the absence of prior cardiac surgery, or
 where such an ablation if felt to be inappropriate in the view of the primary
 investigator

 -  Electrocardiographic documentation of 2 additional episodes of recurrent, sustained
 monomorphic ventricular tachycardia (MMVT) and/or pre-ventricular contraction (PVC)
 induced VT or VF that are terminated by ATP or ICD shocks by device interrogation over
 the past 3 months, since the sentinel ablation (see criteria #4).

 -  Age ≤ 80 yrs.

 Exclusion Criteria:

 -  VT in the absence of cardiomyopathy

 -  Reversible causes of VT including thyroid disorders, acute alcohol intoxication,
 recent major surgical procedures, trauma, or VT clearly produced by recurrent ischemia

 -  Multiple (e.g. >3) clinical VT morphologies, that are thought to originate from widely
 disparate right ventricular (RV) or left ventricular (LV) areas.

 -  Recent cardiac events including myocardial infarction (MI), percutaneous coronary
 intervention (PCI), or valve or bypass surgery in the preceding 3 months, or
 anticipated in the next 3 months

 -  Hypertrophic obstructive cardiomyopathy > Class IV

 -  Progressive Class IV angina or Class IV congestive heart failure (CHF) (including past
 or planned heart transplantation)

 -  Heritable arrhythmias or increased risk for torsade de pointes with class I or III
 drugs

 -  Prior surgical interventions for VT such as an encircling ventriculotomy procedure

 -  Contraindication to appropriate anti-coagulation therapy after ablation

 -  Renal failure requiring dialysis

 -  Prior therapeutic radiation therapy to the left chest that would preclude safe
 ablation of the cardiac target in the judgment of the radiation oncologist

 -  Medical conditions limiting expected survival to <1 year

 -  Women of childbearing potential (unless post-menopausal or surgically sterile)

 -  Participation in any other clinical mortality trial (Participation in other
 non-mortality trials should be reviewed with the clinical trial management center)

 -  Unable to give informed consent