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Radiation Therapy

Noninvasive Cardiac Radioablation for Rapid Heartbeat (ENCORE-VT Trial)

Phase 1 & 2
Waitlist Available
Led By Phillip Cuculich, MD
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must have failed or become intolerant to at least one antiarrhythmic medication (amiodarone, sotalol, or mexiletine)
Patient must be > 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 week, 6 month, 12 month
Awards & highlights

ENCORE-VT Trial Summary

This trial is testing a new, minimally invasive treatment for ventricular tachycardia that doesn't require surgery.

Who is the study for?
This trial is for adults over 18 who have a type of rapid heartbeat called ventricular tachycardia or frequent premature heartbeats, and haven't responded to at least one antiarrhythmic drug. They must have tried or be unsuitable for another procedure called catheter ablation, be fit enough for radiotherapy, and able to consent. Pregnant women, those with extensive past radiation in the treatment area, severe heart failure, multiple types of VT or life expectancy less than a year are excluded.Check my eligibility
What is being tested?
The ENCORE study tests noninvasive cardiac radioablation using stereotactic body radiotherapy (SBRT) to treat ventricular tachycardia. It's designed to see if this targeted radiation can safely correct abnormal heart rhythms when other treatments fail.See study design
What are the potential side effects?
Potential side effects include skin reactions similar to sunburns where the radiation enters the body, fatigue after treatments, nausea or discomfort during SBRT sessions. There may also be rare risks related to targeting the heart such as inflammation around the heart.

ENCORE-VT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have tried at least one antiarrhythmic medication (like amiodarone, sotalol, or mexiletine) and it didn't work for you or caused you problems.
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You must be older than 18 years.
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You have already tried a certain type of heart procedure without success, or you cannot have this procedure, or your heart condition is in a difficult-to-reach area.

ENCORE-VT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 week, 6 month, 12 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 week, 6 month, 12 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Reduction in Ventricular Tachycardia (VT) Burden
Number of Serious Adverse Events
Secondary outcome measures
Health Related Quality of Life (HRQOL)
Number of Adverse Events That Are Possibly/Probably/Definitely Related to Study Treatment
Number of Participants With Reduction in ICD Shocks and LVEF Improvement
+4 more

ENCORE-VT Trial Design

1Treatment groups
Experimental Treatment
Group I: stereotactic body radiotherapy (SBRT)Experimental Treatment1 Intervention
Noninvasive SBRT will be delivered in a single fraction to a region of the heart determined by EP-guidance, using noninvasive electrical mapping combined with anatomic imaging.

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,928 Previous Clinical Trials
2,297,069 Total Patients Enrolled
Phillip Cuculich, MDPrincipal InvestigatorWashington University School of Medicine

Media Library

ENCORE (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02919618 — Phase 1 & 2
Ventricular Tachycardia Research Study Groups: stereotactic body radiotherapy (SBRT)
Ventricular Tachycardia Clinical Trial 2023: ENCORE Highlights & Side Effects. Trial Name: NCT02919618 — Phase 1 & 2
ENCORE (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02919618 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can people with the qualifying condition still enroll in this experiment?

"This study, as it is noted on clinicaltrials.gov, is not currently seeking new participants. The trial was originally posted on 7/1/2016 and updated lastly on 12/1/2021. There are 299 other trials that are recruiting patients right now if you're interested in participating in a clinical trial."

Answered by AI

What are researchers looking to discover through this experiment?

"This clinical trial's primary goal is to assess the reduction in ventricular tachycardia (VT) burden over a period of approximately 90 days. Secondary outcomes include measuring the number of participants who experience a reduction in VT therapies between 6 and 12 months, as well as those with reduced ICD shocks or improved left ventricular ejection fraction (LVEF). For patients with PVC-induced cardiomyopathy, another secondary outcome measures longer-term durability by evaluating the persistence of any reduction in PVC burden based on ambulatory heart monitors during early and late phases of the study."

Answered by AI
~2 spots leftby Mar 2025