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Proton Beam Therapy
Proton Therapy for Cardiac Arrhythmia
N/A
Waitlist Available
Led By Douglas L Packer, MD
Research Sponsored by Konstantinos Siontis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Prior myocardial infarction, or non-ischemic disease, resulting in myocardial dysfunction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing whether proton therapy can help people with ventricular tachycardia who have already had an implantable cardioverter defibrillator and catheter ablation.
Who is the study for?
This trial is for adults under 80 with heart muscle dysfunction and a history of ventricular tachycardia (VT) despite having an ICD and previous catheter ablation. Candidates should have experienced additional VT episodes post-ablation, not be on dialysis, able to consent, and not pregnant or in another mortality study. Excluded are those with reversible VT causes, recent major cardiac events or surgeries, severe angina/heart failure, multiple VT origins across the heart, certain heritable arrhythmias or prior chest radiation.Check my eligibility
What is being tested?
The trial is testing proton particle therapy's safety and effectiveness in reducing ventricular tachycardia episodes in patients who still experience them after standard treatments like ICD implantation and catheter ablation. It aims to see if this therapy can be an alternative when other treatments fail or aren't suitable.See study design
What are the potential side effects?
While specific side effects of proton particle therapy for cardiac arrhythmia are not detailed here, potential risks may include skin reactions at the treatment site, fatigue, damage to nearby organs/tissues such as the lungs or esophagus, and secondary cancers from radiation exposure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have an ICD device for preventing a specific type of abnormal heart rhythm.
Select...
I have had a heart attack or heart disease that affected my heart's ability to function.
Select...
I am 80 years old or younger.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cardiac Arrest
Implantable Cardioverter Defibrillator (ICD) Shocks
Mortality
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Proton Particle Therapy for Cardiac ArrhythmiaExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Konstantinos SiontisLead Sponsor
Douglas L. Packer, MDLead Sponsor
Douglas L Packer, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
172 Total Patients Enrolled
1 Trials studying Arrhythmia
172 Patients Enrolled for Arrhythmia
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart condition is severe, classified as Class IV or higher.I am unable to understand and give consent for treatment.I have had surgery for ventricular tachycardia.I have an ICD device for preventing a specific type of abnormal heart rhythm.I have had a heart attack or heart disease that affected my heart's ability to function.I am a woman who can still have children, not menopausal or surgically sterile.I've had 2 serious heart rhythm episodes in the last 9 months.I have severe heart issues, including angina or heart failure, or I am awaiting a heart transplant.You have a medical condition that is expected to limit your life to less than 1 year.Your heart is not pumping blood effectively, with an ejection fraction below 50%.My previous heart rhythm treatment didn't work, and I can't have or failed other treatments.I am on dialysis for kidney failure.I cannot take blood thinners after a procedure to destroy abnormal tissue.My VT is not caused by reversible factors like thyroid issues or recent surgery.I have had episodes of rapid heart rate without heart muscle disease.I haven't had recent major heart procedures or expect any in the next 3 months.I have a genetic heart rhythm condition that could be worsened by certain medications.I have multiple types of irregular heartbeats from different areas of my heart.I've had radiation therapy to the left side of my chest that makes heart-targeted treatment unsafe.I have not had heart surgery before but need a special heart procedure.I am 80 years old or younger.
Research Study Groups:
This trial has the following groups:- Group 1: Proton Particle Therapy for Cardiac Arrhythmia
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open slots within this trial for enrollees?
"According to the information displayed on clinicaltrials.gov, this trial is still in need of participants. This medical study was first published on March 19th 2021 and its most recent update took place on April 28th 2022."
Answered by AI
Does this clinical research permit geriatric participation?
"This clinical trial is only open to individuals between 18-80 years of age. For younger patients, 8 trials are available; older participants can join 70 different studies."
Answered by AI
How many participants have been approved to partake in this medical experiment?
"Absolutely, patient recruitment for the trial is still underway. The study was initially posted on March 19th 2021 and underwent its most recent update on April 28th 2022. As of now, 10 participants need to be enrolled from a single medical centre."
Answered by AI
Who qualifies to take part in this clinical trial?
"Admittance requirements for this trial include having a diagnosis of arrhythmia and being between 18-80 years old. The study is expected to enroll around 10 participants."
Answered by AI
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