380 Participants Needed

Cardiac Radioablation vs Catheter Ablation for Rapid Heartbeat

(RADIATE-VT Trial)

Recruiting at 9 trial locations
SS
CM
DJ
Overseen ByDavid J Harrington
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Varian, a Siemens Healthineers Company
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

RADIATE-VT is a pivotal, multicenter, randomized trial comparing safety and efficacy between cardiac radioablation (CRA) using the Varian CRA System and repeat catheter ablation (CA), for patients with high-risk refractory ventricular tachycardia (VT) who have experienced VT recurrence after CA and are candidates for additional CA.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that participants must have failed or be intolerant to amiodarone, suggesting that changes to medication might be necessary. Please consult with the trial team for specific guidance.

Is cardiac radioablation generally safe for humans?

Cardiac radioablation (CR) is a new treatment for heart rhythm problems like ventricular tachycardia and has shown promising results. However, it involves high doses of radiation, and while there is a desire for its rapid adoption, it is important to ensure it is done safely. Some studies have noted the need for careful patient selection and monitoring to manage potential risks.12345

How is Varian Cardiac Radioablation (CRA) different from other treatments for rapid heartbeat?

Varian Cardiac Radioablation (CRA) is unique because it uses targeted radiation to treat rapid heartbeats, unlike traditional catheter ablation which uses heat or cold to destroy heart tissue causing the arrhythmia. This non-invasive approach may offer an alternative for patients who cannot undergo catheter ablation.678910

What data supports the effectiveness of the treatment Cardiac Radioablation vs Catheter Ablation for Rapid Heartbeat?

Research shows that radiofrequency catheter ablation (RFCA) is effective in treating ventricular arrhythmia (irregular heartbeats in the lower chambers of the heart), which suggests it may also be beneficial for rapid heartbeats. Additionally, catheter ablation is a well-established treatment for atrial fibrillation (a common type of irregular heartbeat), indicating its potential effectiveness for similar heart rhythm issues.57111213

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My doctor thinks I need another procedure for my heart rhythm issue due to scar tissue.
I have a high-risk type of irregular heartbeat due to heart muscle damage.
I've had repeated VT episodes recorded by a device or ECG after my last VT treatment.
See 6 more

Exclusion Criteria

Patients enrolled in another clinical study the investigator believes to be in conflict with this clinical investigation
I have a serious illness that may limit my life to less than a year.
I have been diagnosed with bundle branch reentry VT.
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either cardiac radioablation (CRA) or repeat catheter ablation (CA) for high-risk refractory ventricular tachycardia

Immediate

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Quality of Life Assessment

Change in quality of life assessed at 6 weeks post treatment

6 weeks post-treatment

What Are the Treatments Tested in This Trial?

Interventions

  • Catheter Ablation (CA)
  • Varian Cardiac Radioablation (CRA)
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Varian Cardiac Radioablation (CRA)Experimental Treatment1 Intervention
Group II: Repeat catheter ablation (CA)Active Control1 Intervention

Varian Cardiac Radioablation (CRA) is already approved in United States for the following indications:

🇺🇸
Approved in United States as Varian CRA System for:
  • Investigational use for refractory ventricular tachycardia (VT)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Varian, a Siemens Healthineers Company

Lead Sponsor

Trials
35
Recruited
7,200+

Published Research Related to This Trial

Radiofrequency catheter ablation (RFCA) was performed on 30 patients with symptomatic ventricular arrhythmia, achieving a high success rate of 93% after re-ablation in cases of relapse.
The procedure was generally safe, with only minor complications reported, and it effectively treated various types of ventricular tachycardia and premature ventricular contractions, making it a viable alternative for patients with these conditions.
Radiofrequency catheter ablation in symptomatic ventricular arrhythmia.Raungratanaamporn, O., Nutakul, T., Chotinaiwattarakul, C., et al.[2019]
Cryoballoon ablation (CBA) for paroxysmal atrial fibrillation (pAF) showed similar effectiveness to radiofrequency ablation (RFA) in achieving freedom from AF after one year, with rates of 60.3% for CBA and 61.1% for RFA.
CBA resulted in significantly shorter procedure and fluoroscopy times compared to RFA, and had a lower rate of cardiac perforations (0% vs 4%), indicating a potentially safer profile.
Cryoballoon versus radiofrequency catheter ablation for paroxysmal atrial fibrillation.Wasserlauf, J., Pelchovitz, DJ., Rhyner, J., et al.[2022]
In a study of 18 patients with lone paroxysmal atrial fibrillation (AF), cryoballoon ablation (CBA) as a first-line treatment achieved a 100% success rate in isolating pulmonary veins during the procedure.
After a follow-up period of about 14 months, 89% of patients remained free of symptomatic AF recurrence without the need for antiarrhythmic drugs, indicating the long-term efficacy of CBA.
Isolating the pulmonary veins as first-line therapy in patients with lone paroxysmal atrial fibrillation using the cryoballoon.Namdar, M., Chierchia, GB., Westra, S., et al.[2012]

Citations

Radiofrequency catheter ablation in symptomatic ventricular arrhythmia. [2019]
Cryoballoon versus radiofrequency catheter ablation for paroxysmal atrial fibrillation. [2022]
Isolating the pulmonary veins as first-line therapy in patients with lone paroxysmal atrial fibrillation using the cryoballoon. [2012]
Long-term development of radiation exposure, fluoroscopy time and contrast media use in daily routine in cryoballoon ablations after implementation of intracardiac echocardiography and other radioprotective measures: experiences from a large single-centre cohort. [2021]
Procedure characteristics and outcomes of atrial fibrillation ablation procedures using cryoballoon versus radiofrequency ablation: A report from the GWTG-AFIB registry. [2021]
Multimodal fusion workflow for target delineation in cardiac radioablation of ventricular tachycardia. [2023]
Cardiac radioablation of incessant ventricular tachycardia in patients with terminal heart failure under permanent left ventricular assist device therapy-description of two cases. [2023]
Cardiac motion and its dosimetric impact during radioablation for refractory ventricular tachycardia. [2023]
A Review of Cardiac Radioablation (CR) for Arrhythmias: Procedures, Technology, and Future Opportunities. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Different characteristics and electrophysiological properties between early and late recurrences after acute successful catheter ablation of idiopathic right ventricular outflow tract arrhythmias during long-term follow-up. [2016]
11.United Statespubmed.ncbi.nlm.nih.gov
Effect of radiofrequency on epicardial myocardium after ablation of ventricular arrhythmias from within coronary sinus. [2019]
An abnormal left ventricular-atrial perforation after radiofrequency catheter ablation: a case report. [2020]
13.United Statespubmed.ncbi.nlm.nih.gov
Transitioning from Radiofrequency Ablation to Cryoablation for Treatment of Pediatric Atrioventricular Nodal Reentrant Tachycardia: A Single Tertiary Center Experience. [2022]
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