Cardiac Radioablation vs Catheter Ablation for Rapid Heartbeat

(RADIATE-VT Trial)

Recruiting at 10 trial locations

Overseen By David J Harrington

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Varian, a Siemens Healthineers Company

Must not be taking: Inotropes

Disqualifiers: Thorax radiation, LVAD, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate

380 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which treatment better addresses a rapid and recurring heart rhythm known as ventricular tachycardia (VT). It compares a new technique, cardiac radioablation (CRA), with the more common method, repeat catheter ablation (CA). The trial seeks participants with a stubborn form of VT that persists despite CA and medication like amiodarone, and who have an implanted cardioverter-defibrillator (ICD). Eligible participants should have heart issues such as cardiomyopathy (heart muscle disease) and have experienced recent, frequent VT episodes. The goal is to identify which treatment is safer and more effective in reducing these episodes. As an unphased trial, this study provides a unique opportunity to explore innovative treatments for VT that could enhance patient outcomes.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that noninvasive cardiac radioablation (CRA) is generally effective and safe for treating ventricular tachycardia (VT), a heart rhythm problem. One study found that patients tolerated the treatment well, with no major safety issues reported. Although side effects can occur, they appear rare and manageable. As CRA continues to be studied for safety and effectiveness, patients receive close monitoring for any issues. The results so far are promising, but further research is needed to confirm these findings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Varian Cardiac Radioablation (CRA) because it offers a non-invasive alternative to traditional catheter ablation for treating rapid heartbeat. Unlike catheter ablation, which requires physical insertion into the heart, CRA uses targeted radiation to modify heart tissue, potentially reducing recovery time and minimizing risks associated with invasive procedures. This novel approach could provide a faster and less risky treatment option for patients, making it a promising development in cardiac care.

What evidence suggests that this trial's treatments could be effective for rapid heartbeat?

In this trial, participants will receive either Varian Cardiac Radioablation (CRA) or repeat catheter ablation (CA) to treat high-risk ventricular tachycardia (VT). Earlier studies have shown promising results for CRA, reducing abnormal heartbeats by 49% within 24 hours and by 70% after one month. This indicates that CRA can significantly lower irregular heartbeats in the short term. Although CRA remains experimental, these early findings suggest it could be effective for individuals who continue to experience VT after other treatments. ^{2 3 4 5 6}

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.

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.

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?

Group I: Varian Cardiac Radioablation (CRA) Experimental Treatment 1 Intervention

Group II: Repeat catheter ablation (CA) Active Control 1 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)

Who Is Running the Clinical Trial?

Varian, a Siemens Healthineers Company

Lead Sponsor

Trials

35

Recruited

7,200+

Published Research Related to This Trial

Cardiac radioablation (cRA) was used as a last-resort treatment for two patients with terminal heart failure on LVAD therapy who had persistent ventricular tachycardia (VT), but both patients continued to experience VT after the procedure, highlighting the challenges of this approach.

While cRA did not result in immediate side effects, the long-term outcomes were poor, with one patient experiencing fatal complications shortly after treatment, suggesting that more effective post-procedural strategies are needed for managing VT in these high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac radioablation of incessant ventricular tachycardia in patients with terminal heart failure under permanent left ventricular assist device therapy-description of two cases. Mehrhof, F., Bergengruen, P., Gerds-Li, JH., et al.[2023]

In a study of eight patients undergoing cardiac radioablation for refractory ventricular tachycardia, it was found that cardiac motion during the cycle averages less than 3 mm, which can vary by location within the heart.

The dosimetric analysis revealed that not accounting for this cardiac motion can significantly reduce the radiation dose delivered to the target areas, with the dose to 95% of the clinical target volumes dropping from 27.0 Gy to 20.5 Gy, highlighting the importance of precise treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac motion and its dosimetric impact during radioablation for refractory ventricular tachycardia. Harms, J., Schreibmann, E., Mccall, NS., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiofrequency catheter ablation in symptomatic ventricular arrhythmia. Raungratanaamporn, O., Nutakul, T., Chotinaiwattarakul, C., et al.[2019]

In a study of 89 pediatric patients with atrioventricular nodal reentrant tachycardia (AVNRT), both radiofrequency (RF) and cryoablation (CA) were found to be safe and effective treatments, with no significant differences in success or recurrence rates between the two methods.

However, RF ablation had a shorter procedure duration and required fewer lesions compared to CA, suggesting it may be more efficient in certain cases, while both methods had no instances of permanent complete atrioventricular blocks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transitioning from Radiofrequency Ablation to Cryoablation for Treatment of Pediatric Atrioventricular Nodal Reentrant Tachycardia: A Single Tertiary Center Experience. Koca, S., Kavurt, V., Ece, I., et al.[2022]

In a study of 1131 cryoballoon ablation procedures for atrial fibrillation from 2013 to 2017, significant reductions in radiation exposure were achieved, with the dose area product halving from 2013 to 2014 and fluoroscopy time decreasing from 11.7 minutes to 5.1 minutes by 2017.

The findings suggest that with increased experience and the implementation of radiation reduction strategies, cryoballoon ablation can achieve radiation levels comparable to those seen in radiofrequency ablation, enhancing safety for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Rubesch-Kütemeyer, V., Fischbach, T., Guckel, D., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Cryoballoon ablation (CBA) for atrial fibrillation was associated with fewer complications (2.3%) compared to radiofrequency ablation (RFA) (5.4%), making it a safer option for patients.

CBA procedures were significantly shorter in duration (129 minutes) compared to RFA (179 minutes), although they required more fluoroscopy time (19 minutes for CBA vs. 11 minutes for RFA).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Procedure characteristics and outcomes of atrial fibrillation ablation procedures using cryoballoon versus radiofrequency ablation: A report from the GWTG-AFIB registry. Friedman, DJ., Holmes, D., Curtis, AB., et al.[2021]

The proposed data integration process for cardiac radioablation (CR) significantly improves the delineation of target volumes by fusing information from electro-anatomical mapping, PET scans, and CT scans, leading to lower variability among clinicians (average dice score of 0.62 compared to 0.32 with traditional methods).

Cardiologists reported increased confidence and efficiency when using the new method, which also reduced the time needed for target delineation, indicating its potential to enhance the accuracy and effectiveness of CR procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal fusion workflow for target delineation in cardiac radioablation of ventricular tachycardia. Rigal, L., Benali, K., Barré, V., et al.[2023]

In a study of 220 patients who underwent successful radiofrequency catheter ablation (RFCA) for drug-refractory right ventricular outflow tract ventricular arrhythmias (RVOT VAs), 20.5% experienced recurrences during a mean follow-up of over 34 months, indicating that while RFCA is effective, recurrences are common.

Factors influencing early recurrences (within 1 year) included specific mapping strategies and shorter activation times, while hypertension was linked to late recurrences, suggesting that different clinical characteristics may predict the timing of VA recurrences.

NCBI (Pubmed)

pubmed.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. Chung, FP., Chong, E., Lin, YJ., et al.[2016]

In a study of 20 patients undergoing radiofrequency ablation for idiopathic ventricular arrhythmias, those treated in the coronary venous system (CVS) showed significantly fewer detectable heart tissue scars three months post-procedure compared to those treated in the right ventricular outflow tract (RVOT).

Only 3 out of 10 patients in the CVS group had detectable late gadolinium enhancement (LGE) on cardiac MRI, while 9 out of 10 in the RVOT group did, suggesting that RF ablation in the CVS may be less effective in creating lasting lesions in the heart tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of radiofrequency on epicardial myocardium after ablation of ventricular arrhythmias from within coronary sinus. Candemir, B., Ozyurek, E., Vurgun, K., et al.[2019]

Cardiac radioablation (CR) shows promise as a treatment for arrhythmias like ventricular tachycardia and atrial fibrillation, but its clinical adoption must prioritize safety and effectiveness due to unique challenges in radiation therapy.

The review highlights the diverse technical approaches used in CR, including various radiation types and delivery systems, emphasizing the need for standardized procedures to improve outcomes and facilitate multicenter evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of Cardiac Radioablation (CR) for Arrhythmias: Procedures, Technology, and Future Opportunities. Lydiard PGDip, S., Blanck, O., Hugo, G., et al.[2021]

Cardiac radiofrequency catheter ablation (RFCA) can lead to severe complications, including internal cardiac perforation, as demonstrated in a case of a 47-year-old male who required surgical intervention after experiencing this complication.

The case highlights the need for caution among medical professionals when performing RFCA, as the risks of serious outcomes like cardiac perforation necessitate careful consideration by both doctors and patients before proceeding with the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An abnormal left ventricular-atrial perforation after radiofrequency catheter ablation: a case report. Tao, T., Zheng, J., Xu, H., et al.[2020]

Citations

1. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(25)00300-5/fulltext

CE-499648-004 CARDIAC RADIOABLATION VERSUS ... Cardiac radioablation (CRA) using stereotactic body radiotherapy is an experimental therapy for high-risk refractory VT. There have been no international ...

2. varian.com varian.com/about-varian/newsroom/press-releases/varian-announces-first-participant-treated-radiate-vt-0

Varian Announces First Participant Treated in RADIATE-VT ... RADIATE-VT is the first international, multi-center, randomized controlled trial to evaluate the safety and efficacy of cardiac radioablation (CRA) compared to ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05765175

Study Details | NCT05765175 | Cardiac RADIoablation ... RADIATE-VT is a pivotal, multicenter, randomized trial comparing safety and efficacy between cardiac radioablation (CRA) using the Varian CRA System and repeat ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9975004/

Short-term and long-term effects of noninvasive cardiac ... In the short-term assessment, the total burden of ventricular beats decreased by 49% within 24 hours after radioablation and further decreased by 70% at 1 month ...

5. varian.com varian.com/about-varian/newsroom/press-releases/varian-receives-investigational-device-exemption-cardiac

Varian Receives Investigational Device Exemption for ... The RADIATE-VT trial will be the first international, multi-center, randomized controlled trial to evaluate the safety and efficacy of cardiac radioablation ( ...

6. medicalaffairs.varian.com medicalaffairs.varian.com/RADIATE-VT-Clinical-Trial

RADIATE-VT Clinical Trial The purpose of the trial is to compare the safety and efficacy of cardiac radioablation with Varian's CRA system to repeat standard-of-care catheter ablation.