Tachycardia, VentricularRADIATE-VTNCT05765175
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)
A study testing Varian Cardiac Radioablation (CRA) and Catheter Ablation (CA) in people with Tachycardia, Ventricular, run by Varian, a Siemens Healthineers Company at 12 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tachycardia, Ventricular
- What is being tested?
- Varian Cardiac Radioablation (CRA) and Catheter Ablation (CA)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 12 sitesUnited States
- Study dates
- 21 Apr 2023to May 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- High-risk refractory VT, defined as:
- Ischemic and/or nonischemic cardiomyopathy, and
- Recurrent sustained monomorphic VT, defined as at least one of the following below, documented by ICD interrogation or ECG in the prior 6 months, and having occurred after the last VT ablation:
- A: ≥3 episodes of monomorphic VT treated with anti-tachycardia pacing (ATP) at least one of which is symptomatic
- B: ≥1 appropriate ICD shock
- C: ≥3 episodes of sustained monomorphic VT within 24 hours treated with ICD shock or ATP
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- D: sustained monomorphic VT below detection rate of ICD documented by ECG, and
- Left ventricular ejection fraction (LVEF) ≤49% and
- Previously underwent at least one standard of care CA for VT.
- Presence of a clinical indication for a repeat CA procedure for scar-mediated VT in the judgement of the treating investigator.
- Has failed amiodarone therapy or is intolerant to amiodarone:
- Failed amiodarone therapy is defined as: appropriate ICD therapy or sustained monomorphic VT having occurred while the patient was taking amiodarone (minimum cumulative dose of 10 g).
- Intolerant to amiodarone is defined as: previously tried or taken amiodarone but stopped due to medication related side effects or toxicities.
- Deemed to be medically and technically a candidate for further CA by the electrophysiologist investigator.
- Presence of an ICD.
- At least 18 years of age (or meets local age of majority).
- Ability to understand and willingness to sign an IRB approved written informed consent document.
Who cannot join
- Contraindication to a CA procedure for VT (e.g., presence of mobile LV thrombus, active systemic infection, active ischemic or other reversible causes of VT).
- Patients with expected, right ventricular scar only.
- Any prior radiation to the thorax region of the body.
- Known medical conditions associated with higher risk of radiotherapy complications in the judgement of the radiation oncologist (i.e., active connective tissue disorders, interstitial lung disease, etc.) that would preclude safe delivery of CRA.
- Current use of inotropes.
- Presence of a left-ventricular assist device (LVAD).
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- Scheduled for LVAD or heart transplant procedures.
- Presence of a systemic illness likely to limit survival to < 1 year.
- VT ablation procedure performed within the prior 2 weeks.
- Polymorphic VT or ventricular fibrillation (VF) as the primary clinical heart rhythm, as indicated by 12-lead ECG and/or ICD interrogation.
- >3 distinct clinical monomorphic VT morphologies on ICD interrogation since the prior CA, or >5 induced monomorphic VT morphologies during NIPS testing.
- Incessant VT that is hemodynamically unstable.
- Bundle branch reentry (BBR) VT.
- Pregnant and/or breastfeeding. (Patient denial is sufficient for enrollment).
- Patients of childbearing potential who:
- are not on a medically effective means of birth control at the time of screening or do not start a medically effective means of birth control prior to randomization; or
- do not agree to continue medically effective means of birth control until they have completed their assigned therapy; or
- do not agree to be on a medically effective means of birth control if they are treated with CRA after their index CA procedure.
- Patients enrolled in another clinical study the investigator believes to be in conflict with this clinical investigation.
- Patients enrolled or planned to be enrolled in another cardiac radioablation clinical study or registry.
- Patients with any other medical condition or laboratory value that would, at the discretion of the investigator, preclude the patient from participation in this clinical investigation.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
United States12 sites, 12 recruiting
- Recruiting
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Christine Pellegrini, 617-732-5241, cpellegrini@bwh.harvard.edu
Deborah Manuelian, 617-732-5087, dmanuelian@bwh.harvard.edu
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
843-792-5998
Jeffrey Winterfield, MD
- Recruiting
University of Missouri
Columbia, Missouri, 65211
Nadine Kallas, 573-884-2194, nkallas@health.missouri.edu
Rahul Jain, MD
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Adrianne Miller, 614-688-8252, adrianne.miller3@osumc.edu
EP Research Phone, 614-685-4394, _cardiologyepresearchnurses_@osumc.edu
- Recruiting
Hartford Hospital
Hartford, Connecticut, 06102
Megan Scalzo, 860-972-4268, megan.scalzo@hhchealth.org
Jennifer Rossi, 860-972-5311, jennifer.rossi@hhchealth.org
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Kelsey Duggin, 310-967-8408, kelsey.duggin@csmns.org
Goran Stankovic, (310)967-8408, goran.stankovic@cshs.org
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Terry Weyand, 615-322-9349, terry.l.weyand@vumc.org
William G Stevenson, MD
- Recruiting
Yale University
New Haven, Connecticut, 06511
Margaret Leiss, RN, 203-737-9519, Margaret.leiss@yale.edu
Kenneth Roberts, MD
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Karen Tang, 267-299-9618, Karen.Tang1@Pennmedicine.upenn.edu
Keith Cengel, MD
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15260
Eric Pasquantonio, 412-647-8210, pasquantonioej@upmc.edu
Krishna Kancharla, MD
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Brian Liddell, 507-255-8717, liddell.brian@mayo.edu
Study Team Heart Rhythm Services, 5072550774
- Recruiting
Washington University
St Louis, Missouri, 63110
Kaitlin Moore, kaitlin.m.moore@wustl.edu
Daniel Cooper, MD
About this study
Official title: 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 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.
- Conditions
- Tachycardia, Ventricular
- Being tested
- Varian Cardiac Radioablation (CRA), Catheter Ablation (CA)
- Keywords
- Cardiac radioablation, Ventricular tachycardia, Catheter ablation, Refractory ventricular tachycardia, High risk, SBRT
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Varian Cardiac Radioablation (CRA)Device
Subjects randomized to CRA will be treated with the Varian CRA system according to a uniform CRA protocol. A dose of 25 Gy in a single fraction is prescribed to the planning target volume (PTV), and delivered using a stereotactic body radiotherapy (SBRT) technique.
Catheter Ablation (CA)Procedure or surgery
Subjects randomized to the CA arm will be treated according to a uniform CA protocol.
| Study group | Role | What they receive |
|---|---|---|
| Repeat catheter ablation (CA) | Active comparator | Not described Receives: Procedure: Catheter Ablation (CA) |
| Varian Cardiac Radioablation (CRA) | Experimental | Not described Receives: Device: Varian Cardiac Radioablation (CRA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Co-primary safety endpoint: freedom from treatment-attributed (i.e., probably or definitely related) serious adverse events (SAEs)
Freedom from treatment-attributed (i.e., probably or definitely related) serious adverse events (SAEs), evaluated from treatment through 12 months post-treatment.
Measured: Treatment through 12 months post-treatment
Co-primary efficacy endpoint: Freedom from death, and appropriate ICD shock, and VT storm.
Freedom from death, and appropriate ICD shock, and VT storm, where death will be counted from randomization through 12 months, and shock and storm will be counted starting after a 30-day period immediately post-randomization and continuing through 12 months post randomization.
Measured: Death will be counted from randomization through 12 months, and shock and storm will be counted starting after a 30-day period immediately post-randomization and continuing through 12 months post randomization
Secondary outcomes (3)
Change in quality of life at 6 weeks post treatment:
Change in quality of life at 6 weeks post treatment measured by the Short Form Health Survey 36 (SF-36) Health Change Question. This item asks the subject to rate their health in general compared to one year ago in a 5-point scale of 1 (much better), 2 (somewhat better), 3 (about the same), 4 (somewhat worse), 5 (much worse).
Measured: From baseline through 6 weeks post treatment
VT burden reduction
VT burden reduction measured as a ≥75% reduction in appropriate ICD therapies (ATP, shock), comparing a 6-month period before randomization and a 6-month period starting after a 30-day period immediately post-randomization.
Measured: From 6 months before randomization through to a 6 month period starting after a 30-day period immediately post-randomization
Change in quality of life (Social Functioning) at 6 weeks post treatment
Change in quality of life (Social Functioning) measured by the Short Form Health Survey 36 (SF-36) Social Functioning item (social activities in past 4 weeks). This item asks the subject to rate how much of the time their physical health or emotional problems interfered with their social activities in the past 4 weeks in a 5-point scale of 1 (All of the time), 2 (Most of the time), 3 (Some of the time), 4 (A little bit of the time), 5 (None of the time).
Measured: From baseline through 6 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start21 Apr 2023
- Primary completionOct 2028 (estimated)
- Study completionMay 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tachycardia, VentricularStudies of the same condition, open and under way.
- More trials run by Varian, a Siemens Healthineers CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The Varian CRA trial is a multicenter, international, pivotal, 2-arm randomized controlled trial (RCT). Subjects will be randomized 1:1 to CRA or repeat CA. Randomization will be stratified by (1) enrolling institution and (2) NYHA class I/II vs. III/IV. Blinding will not be used in this trial, as the different interventions cannot be blinded.
- Masking
- None (open label)
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Varian, a Siemens Healthineers Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765175
- Sponsor's protocol ID
- VAR-2022-01
- Acronym
- RADIATE-VT
- Status last verified
- Oct 2026
- First submitted
- 15 Feb 2023
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia
- ClinicalTrials.gov ID
- NCT05765175
- Acronym / sponsor ID
- RADIATE-VT / VAR-2022-01
- Conditions
- Tachycardia, Ventricular
- Keywords
- Cardiac radioablation, Ventricular tachycardia, Catheter ablation, Refractory ventricular tachycardia, High risk, SBRT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Varian, a Siemens Healthineers CompanyIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2023 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- May 2032 (estimated)
- First posted
- 13 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The Varian CRA trial is a multicenter, international, pivotal, 2-arm randomized controlled trial (RCT). Subjects will be randomized 1:1 to CRA or repeat CA. Randomization will be stratified by (1) enrolling institution and (2) NYHA class I/II vs. III/IV. Blinding will not be used in this trial, as the different interventions cannot be blinded.
| Arm | Type | Receives |
|---|---|---|
| Repeat catheter ablation (CA) | Active comparator | Procedure: Catheter Ablation (CA) |
| Varian Cardiac Radioablation (CRA) | Experimental | Device: Varian Cardiac Radioablation (CRA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- High-risk refractory VT, defined as:
- A: ≥3 episodes of monomorphic VT treated with anti-tachycardia pacing (ATP) at least one of which is symptomatic
- B: ≥1 appropriate ICD shock
- C: ≥3 episodes of sustained monomorphic VT within 24 hours treated with ICD shock or ATP
- D: sustained monomorphic VT below detection rate of ICD documented by ECG, and
Key exclusion criteria (21 listed)
- Contraindication to a CA procedure for VT (e.g., presence of mobile LV thrombus, active systemic infection, active ischemic or other reversible causes of VT).
- Patients with expected, right ventricular scar only.
- Any prior radiation to the thorax region of the body.
- Known medical conditions associated with higher risk of radiotherapy complications in the judgement of the radiation oncologist (i.e., active connective tissue disorders, interstitial lung disease, etc.) that would preclude safe delivery of CRA.
- Current use of inotropes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Varian Cardiac Radioablation (CRA)Subjects randomized to CRA will be treated with the Varian CRA system according to a uniform CRA protocol. A dose of 25 Gy in a single fraction is prescribed to the planning target volume (PTV), and delivered using a stereotactic body radiotherapy (SBRT) technique. | Device | Varian Cardiac Radioablation (CRA) |
| Catheter Ablation (CA)Subjects randomized to the CA arm will be treated according to a uniform CA protocol. | Procedure or surgery | Repeat catheter ablation (CA) |
Primary outcome
Co-primary safety endpoint: freedom from treatment-attributed (i.e., probably or definitely related) serious adverse events (SAEs)
Time frame: Treatment through 12 months post-treatment
Freedom from treatment-attributed (i.e., probably or definitely related) serious adverse events (SAEs), evaluated from treatment through 12 months post-treatment.
Co-primary efficacy endpoint: Freedom from death, and appropriate ICD shock, and VT storm.
Time frame: Death will be counted from randomization through 12 months, and shock and storm will be counted starting after a 30-day period immediately post-randomization and continuing through 12 months post randomization
Freedom from death, and appropriate ICD shock, and VT storm, where death will be counted from randomization through 12 months, and shock and storm will be counted starting after a 30-day period immediately post-randomization and continuing through 12 months post randomization.
3 secondary outcomes
Change in quality of life at 6 weeks post treatment:
Time frame: From baseline through 6 weeks post treatment
VT burden reduction
Time frame: From 6 months before randomization through to a 6 month period starting after a 30-day period immediately post-randomization
Change in quality of life (Social Functioning) at 6 weeks post treatment
Time frame: From baseline through 6 weeks post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Varian Cardiac Radioablation (CRA) and Catheter Ablation (CA) in people with Tachycardia, Ventricular, run by Varian, a Siemens Healthineers Company at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claire McCann, PhD (437.240.4531, claire.mccann@varian.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Co-primary safety endpoint: freedom from treatment-attributed (i.e., probably or definitely related) serious adverse events (SAEs) (time frame: Treatment through 12 months post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.