Proton Particle Therapy for Cardiac Arrhythmia
Primary Purpose
Cardiac Arrhythmia
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Proton Particle Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Cardiac Arrhythmia focused on measuring Ventricular Tachycardia, Cardiac Ablation, Proton Radiation Therapy
Eligibility Criteria
Inclusion Criteria:
- Prior myocardial infarction, or non-ischemic disease, resulting in myocardial dysfunction
- EF <50%
- 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.
- 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.
- 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.
- 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.
- Age <=80 years.
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 (HOCM) >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 judgement of the radiation oncologist.
- Medical conditions limiting expected survival <1 year.
- Women of child bearing 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.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Proton Particle Therapy for Cardiac Arrhythmia
Arm Description
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.
Outcomes
Primary Outcome Measures
Mortality
Total number of subject deaths
Implantable Cardioverter Defibrillator (ICD) Shocks
Total number of recurrent ICD shocks
Recurrent Ventricular Tachycardia (VT)
Total number of recurrent VT requiring repetitive antitachycardia pacing (ATP) device therapy
Cardiac Arrest
Total number of cardiac arrests
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04392193
Brief Title
Proton Particle Therapy for Cardiac Arrhythmia
Official Title
Proton Particle Therapy for Cardiac Arrhythmia Extracorporeal Energy Source Ablation of Cardiac Tissue: A First Stage Early Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 19, 2021 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Konstantinos Siontis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrhythmia
Keywords
Ventricular Tachycardia, Cardiac Ablation, Proton Radiation Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Proton Particle Therapy for Cardiac Arrhythmia
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Proton Particle Therapy
Intervention Description
Proton therapy will be delivered in a single fraction using the Probeat-V system
Primary Outcome Measure Information:
Title
Mortality
Description
Total number of subject deaths
Time Frame
2 years
Title
Implantable Cardioverter Defibrillator (ICD) Shocks
Description
Total number of recurrent ICD shocks
Time Frame
2 years
Title
Recurrent Ventricular Tachycardia (VT)
Description
Total number of recurrent VT requiring repetitive antitachycardia pacing (ATP) device therapy
Time Frame
2 years
Title
Cardiac Arrest
Description
Total number of cardiac arrests
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Prior myocardial infarction, or non-ischemic disease, resulting in myocardial dysfunction
EF <50%
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.
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.
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.
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.
Age <=80 years.
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 (HOCM) >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 judgement of the radiation oncologist.
Medical conditions limiting expected survival <1 year.
Women of child bearing 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konstantinos Siontis, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Proton Particle Therapy for Cardiac Arrhythmia
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