A Study to Evaluate Proton Therapy for Cardiac Arrhythmias

Overview

About this study

The purpose of this research is to gather information on the safety and effectiveness of proton radiation therapy in reducing the number of VT episodes in people like you who continue to experience VT despite treatment with an ICD and undergoing a previous catheter ablation.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Konstantinos Siontis, M.D.

Open for enrollment

Contact information:

Heart Rhythm Services Research Office

(507) 255-7456

More information

Publications

Publications are currently not available
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CLS-20507938

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