What side effects are associated with this type of intervention?

Common treatments for arrhythmia, such as radiation therapy, can have several side effects. Acute side effects include skin irritation, fatigue, and localized pain. Chronic side effects, especially relevant to cardiac treatments, can involve damage to the heart muscle, leading to cardiomyopathy, heart failure, and an increased risk of coronary artery disease. Proton radiation therapy, which targets arrhythmogenic heart tissue, aims to reduce these risks by delivering radiation more precisely, thereby minimizing damage to surrounding healthy tissue.

What prior FDA approvals exist?

The FDA has approved several antiarrhythmic drugs for the treatment of arrhythmias, including amiodarone, sotalol, and diltiazem. These medications work by altering the electrical signals in the heart to maintain a regular rhythm. Additionally, catheter ablation, a procedure that targets and destroys arrhythmogenic heart tissue using radiofrequency or cryoenergy, has been a standard treatment for certain types of arrhythmias. While proton radiation therapy is a novel approach under investigation, it aims to achieve similar outcomes by precisely targeting and reducing arrhythmogenic heart tissue, potentially offering a non-invasive alternative to traditional ablation techniques.

What other types of research exist?

Promising novel alternatives to Proton Radiation Therapy for arrhythmia patients include: 1) Hybrid therapy combining epicardial and endocardial approaches to create complex radiofrequency lesions in the left atrium, and 2) Stereotactic Ablative Body Radiotherapy (SABR), which delivers focused ablative doses of radiation with a low probability of side effects.

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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

Must not have

Hypertrophic obstructive cardiomyopathy (HOCM) >Class IV

Unable to give informed consent.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying proton radiation therapy, a treatment using high-energy particles, to help patients with ventricular tachycardia who haven't responded to other treatments. The therapy targets specific heart areas causing abnormal rhythms, potentially offering a new solution for these patients. Proton radiation therapy is a novel approach being explored for treating ventricular tachycardia, especially in patients who have not responded to other treatments.

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.

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.

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 below

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I have an ICD device for preventing a specific type of abnormal heart rhythm.

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I have had a heart attack or heart disease that affected my heart's ability to function.

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I am 80 years old or younger.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My heart condition is severe, classified as Class IV or higher.

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I am unable to understand and give consent for treatment.

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I have had surgery for ventricular tachycardia.

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I am a woman who can still have children, not menopausal or surgically sterile.

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I have severe heart issues, including angina or heart failure, or I am awaiting a heart transplant.

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I am on dialysis for kidney failure.

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I cannot take blood thinners after a procedure to destroy abnormal tissue.

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I have had episodes of rapid heart rate without heart muscle disease.

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I haven't had recent major heart procedures or expect any in the next 3 months.

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I have a genetic heart rhythm condition that could be worsened by certain medications.

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I've had radiation therapy to the left side of my chest that makes heart-targeted treatment unsafe.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cardiac Arrest

Implantable Cardioverter Defibrillator (ICD) Shocks

Mortality

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Proton Particle Therapy

2021

N/A

~10

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for arrhythmia include medications, electrical cardioversion, catheter ablation, and emerging therapies like proton radiation therapy. Medications such as beta-blockers and antiarrhythmics work by altering the electrical signals in the heart to maintain a regular rhythm. Electrical cardioversion uses controlled electric shocks to reset the heart's rhythm. Catheter ablation involves destroying small areas of heart tissue that cause abnormal rhythms. Proton radiation therapy, a newer approach, targets and reduces arrhythmogenic heart tissue with high precision, potentially minimizing damage to surrounding healthy tissue. Understanding these mechanisms is crucial for arrhythmia patients as it helps tailor treatment plans to effectively manage their condition while minimizing side effects.