Ensayos clínicos

Inclusion Criteria:

• Prior myocardial infarction or non-ischemic disease resulting in myocardial dysfunction.
• An 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 9 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 PVC induced VT or VF that are terminated by ATP or ICD shocks by device interrogation over the past 9 months, since the sentinel ablation.  Also included, incessant VT that does not fall within device parameters for activation of ATP or shock delivery, or is refractory to medication titration.
• Age, between 5-80 years old.

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 RV or LV areas.
• Recent cardiac events including MI, 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 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.

Eligibility last updated 2/17/22. Questions regarding updates should be directed to the study team contact.