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Radiation Therapy

Cardiac Radioablation vs Catheter Ablation for Rapid Heartbeat (RADIATE-VT Trial)

N/A

Recruiting

Research Sponsored by Varian, a Siemens Healthineers Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 18 years of age (or meets local age of majority)

High-risk refractory VT, defined as ischemic and/or nonischemic cardiomyopathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up treatment through 12 months post-treatment

Awards & highlights

RADIATE-VT Trial Summary

This trial compares two treatments for people with a condition that causes rapid heartbeat and who have had it recur after treatment.

Who is the study for?

This trial is for adults with a weak heart pump (LVEF ≤35%) and high-risk, stubborn ventricular tachycardia that didn't stop after previous catheter ablation. Candidates must have failed or can't tolerate amiodarone therapy, need another ablation, and have an ICD implanted. Pregnant individuals, those not using birth control, or with conditions limiting survival to under a year are excluded.Check my eligibility

What is being tested?

RADIATE-VT compares two treatments for severe rapid heartbeat: cardiac radioablation using Varian's system versus another round of catheter ablation. Patients who've had VT return after initial catheter treatment will be randomly assigned to one of these options to see which is safer and more effective.See study design

What are the potential side effects?

Potential side effects include typical risks associated with radiation therapy such as skin reactions and fatigue, as well as specific complications from targeting the heart like damage to nearby organs. Catheter ablation may cause bleeding, infection at the entry site, or heart damage.

RADIATE-VT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am at least 18 years old.

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I have a high-risk type of irregular heartbeat due to heart muscle damage.

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I've had repeated VT episodes recorded by a device or ECG after my last VT treatment.

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I cannot take amiodarone because it didn't work for me or caused side effects.

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My heart's pumping ability is significantly reduced.

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I have had at least one standard treatment for ventricular tachycardia.

RADIATE-VT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ treatment through 12 months post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~treatment through 12 months post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and treatment through 12 months post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Co-primary efficacy endpoint: Freedom from death, and appropriate ICD shock, and VT storm.

Co-primary safety endpoint: freedom from treatment-attributed (i.e., probably or definitely related) serious adverse events (SAEs)

Secondary outcome measures

Change in quality of life (Social Functioning) at 6 weeks post treatment

Change in quality of life at 6 weeks post treatment

VT burden reduction

RADIATE-VT Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Varian Cardiac Radioablation (CRA)Experimental Treatment1 Intervention

Group II: Repeat catheter ablation (CA)Active Control1 Intervention

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Varian, a Siemens Healthineers CompanyLead Sponsor

30 Previous Clinical Trials

6,893 Total Patients Enrolled

Media Library

Varian Cardiac Radioablation (CRA) (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05765175 — N/A

Ventricular Tachycardia Research Study Groups: Varian Cardiac Radioablation (CRA), Repeat catheter ablation (CA)

Ventricular Tachycardia Clinical Trial 2023: Varian Cardiac Radioablation (CRA) Highlights & Side Effects. Trial Name: NCT05765175 — N/A

Varian Cardiac Radioablation (CRA) (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05765175 — N/A

Frequently Asked Questions

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

Are there any available slots to participate in this experiment?

"Affirmative. According to the information found on clinicaltrials.gov, this investigation is actively recruiting patients, having first been published on April 21st 2023 and revised most recently on April 23rd 2023. The trial requires 380 subjects from one medical centre."

Answered by AI

How many participants have been enrolled in this clinical experiment?

"Indeed, the details presented on clinicaltrials.gov indicate that this medical trial is actively looking for participants. The study was first made available on April 21st 2023 and has since been updated on April 23rd of the same year. 380 patients are needed to be recruited from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)

2023. "Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05765175.

All > Paroxysmal Supraventricular Tachycardia