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CompletedNCT04392193Updated Jan 15, 2025

Proton Particle Therapy for Cardiac Arrhythmia

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

From the registry’s dates

  • Primary completion was Mar 2024, 2 years 7 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Cardiac Arrhythmia

Keywords

  • Ventricular Tachycardia
  • Cardiac Ablation
  • Proton Radiation Therapy
03

In context

Arrhythmias, Cardiac

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 →

Lead sponsor

This is the only study on the registry with Konstantinos Siontis as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Prior myocardial infarction, or non-ischemic disease, resulting in myocardial dysfunction
  2. EF \<50%
  3. An implanted ICD device as secondary prevention for monomorphic VT/VF (MMVT/MMVF). This includes patients who receive a device for primary prevention and then have recurrent sustained monomorphic VT or VF.
  4. Have failed a prior catheter-based ablation for VT/VF after device implantation or have a contraindication to repeat ablation and have failed reasonable drug options over the 9 months prior to consideration of particle therapy.
  5. Repeat ablation from an epicardial venue in the absence of prior cardiac surgery, or where such an ablation is felt to be inappropriate in the view of the PI.
  6. 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 (see criteria #4). Also included, incessant VT that does not fall within device parameters for activation of ATP or shock delivery or is refractory to medication titration.
  7. Age \<=80 years.

Exclusion criteria

Exclusion Criteria:

  1. VT in the absence of cardiomyopathy.
  2. Reversible causes of VT including thyroid disorders, acute alcohol intoxication, recent major surgical procedures, trauma, or VT clearly produced by recurrent ischemia.
  3. Multiple (e.g.>3) clinical VT morphologies that are thought to originate from widely disparate RV or LV areas.
  4. Recent cardiac events including MI, PCI, or valve or bypass surgery in the preceding 3 months, or anticipated in the next 3 months.
  5. Hypertrophic obstructive cardiomyopathy (HOCM) >Class IV
  6. Progressive Class IV angina, or Class IV CHF (including past, or planned heart transplantation).
  7. Heritable arrhythmias or increased risk for torsade de pointes with Class I or III drugs.
  8. Prior surgical interventions for VT such as an encircling ventriculotomy procedure.
  9. Contraindication to appropriate anti-coagulation therapy after ablation.
  10. Renal failure requiring dialysis.
  11. Prior therapeutic radiation therapy to the left chest that would preclude safe ablation of the cardiac target in the judgement of the radiation oncologist.
  12. Medical conditions limiting expected survival \<1 year.
  13. Women of child bearing potential (unless post-menopausal or surgically sterile)
  14. Participation in any other clinical mortality trial (participation in other non-mortality trials should be reviewed with the clinical trial management center)
  15. Unable to give informed consent.
05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    Proton Particle Therapy for Cardiac Arrhythmia

    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

Interventions

  • RadiationProton Particle Therapy

    Proton therapy will be delivered in a single fraction using the Probeat-V system

06

What researchers measure

Primary outcomes

  1. Mortality

    Total number of subject deaths

    Time frame: 2 years

  2. Implantable Cardioverter Defibrillator (ICD) Shocks

    Total number of recurrent ICD shocks

    Time frame: 2 years

  3. Recurrent Ventricular Tachycardia (VT)

    Total number of recurrent VT requiring repetitive antitachycardia pacing (ATP) device therapy

    Time frame: 2 years

  4. Cardiac Arrest

    Total number of cardiac arrests

    Time frame: 2 years

07

Study locations

1 site
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04392193
Lead sponsor
Konstantinos Siontis
Responsible party
Konstantinos Siontis (Principal Investigator, Mayo Clinic) — Sponsor-investigator
First posted
May 18, 2020
Start date
Mar 19, 2021
Primary completion
Mar 9, 2024
Completion
Mar 9, 2024
Last update
Jan 15, 2025

Study contacts

Konstantinos Siontis, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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