Ventricular TachycardiaCARA-VTNCT07590908
CARA-VT: a Dosimetric in Silico Study
An observational study of Ventricular Tachycardia and Ventricular Arrhythmias, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
Ventricular tachycardia (VT) is a potentially deadly condition, common in patients with structural heart disease or dilated cardiomyopathy. VTpatients are currently treated with anti-arrhythmic drugs, implanted cardioverter defibrillators or invasive catheter ablation (CA) but the overall success rate of this… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia, Ventricular Arrhythmias
- How many people
- 23 participants
- Where
- 1 siteItaly
- Study dates
- 8 Feb 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Thirty patients suffering recurrent VT with clinical indication to receive invasive catheter ablation will be included in the study
Who may be able to join
- Recurrent VT with clinical indication to receive catheter ablation
- Written informed consent
- Patient's ability to understand the characteristics and consequences of the clinical study
- Invasive mapping data
Who cannot join
- Allergy to iodinated contrast media
- Pregnancy and breastfeeding
- Younger than 18 years
Trial locations and contacts
1 site in 1 country.
Italy1 site
SC Cardiologia, Fondazione IRCCS Policlinico San Matteo
Pavia, Pavia, 27100
About this study
Official title: Non-invasive CArdiac RAdioablation for Ventricular Tachycardia: a Feasibility Dosimetric in Silico Study Based on a Prospective Cohort of Patients to Compare Photon to Proton and to Carbon Ion Radiotherapy
Ventricular tachycardia (VT) is a potentially deadly condition, common in patients with structural heart disease or dilated cardiomyopathy. VTpatients are currently treated with anti-arrhythmic drugs, implanted cardioverter defibrillators or invasive catheter ablation (CA) but the overall success rate of this techniqueis still suboptimal.
One of the main reasons is an anatomically inaccessible location of VT's origin (within the mid-wall of the myocardium, on the epicardial site or adjacent to critical structures). Moreover, repeated invasive ablation, technical difficulties or patient comorbidities can lead to non-eligibility for CA. Accordingly, a rationale exists to adopt more effective and less invasive therapies.
Read more
A promising novel non-invasive treatment option for refractory VT is stereotactic arrhythmia radio-ablation (STAR), originally born for cancer treatment, which consists in the application of high-energy photons in a single 25 Gy dose to limited areas of the ventricles, also to those inaccessible for CA, recognized through non-invasive surface ECG-mapping as the origin of VT. Preliminary small case series described good tolerance and improved VT burden during follow-up.
Due to the encouraging physical and biological characteristics of protons and carbon ions, the dose to surrounding healthy tissues could potentially be better spared in comparison with photons. Especially, the cardiac healthy sub-structures might benefit from the use of particle beams instead of photons. On the other hand, due to range uncertainties affecting particle beams, delivering an ideal radiation treatment with heavy ions to fast-moving targets such as the heart, is more complex. So far, the feasibility and the safety of cardiac radiotherapy with protons and heavy ions have only been evaluated in animal models and recently in the first in man case managed by the collaboration between CNAO and San Matteo Cardiology Department in a patient treated with compassionate aim.
To date, feasibility and safety data showing potential advantages of particles over photon therapy in dose distributions are missing.
Therefore, we propose a study aimed to compare different radiation therapy treatment modalities (photons vs. particle therapy: protons and carbon ions) simulating the RT treatment of ventricular arrhythmias on real patients candidates to invasive catheter ablation treatment.
STAR with photons was first reported in 2013 and an increasingly number of case reports and case series have been published ever since, showing an acceptable safety profile and promising efficacy.
Decreasing the dose to the surrounding healthy heart tissues is expected to be very advantageous for patients.
Particle therapy based on its dosimetric physical selectivity compared to SBRT (Stereotactic Body Radiotherapy) with photons might have the potential to both lower off-target doses and lower risk of possible side effects.
- Conditions
- Ventricular Tachycardia, Ventricular Arrhythmias
- Keywords
- Ventricular tachycardia, VT, Stereotactic arrhythmia radioablation, STAR, photons, carbon ions, particle therapy, radiation therapy, Ventricular Arrhythmias, radiotherapy, radioablation, non-invasive, SBRT, Stereotactic Body Radiotherapy, RT treatment, invasive catheter ablation
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Photons (control group) | "Stereotactic arrhythmia radioablation" (STAR) based on the delivery of a high, single dose (25 Gy) of photons to selected cardiac tissue (to limited areas of the ventricles), also to those inaccessible for CA, recognized through non-invasive surface ECG-mapping as the origin of VT. | |
| Particle therapy with Protons and Carbon ions (Intervention group) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of particle therapy (protons and carbon ions)
To verify the feasibility of particle therapy plans in patients with refractory VT.
Plans will be considered feasible whether the dosimetric criteria outlined will be achieved in no fewer than 90% of enrolled patients (30 enrolled patients).
Measured: up to 3 years
Dose sparing on surrounding non-target tissues with particle therapy (protons and carbon ions)
To compare simulated RT plans with protons, carbon ions and photons, and quantify the differences in terms of dose released to surrounding cardiac and non-cardiac healthy tissues.
Comparison of simulated RT plans, with protons, carbon ions and photons, by using cardiac motion management, optimizing the treatment plan on different cardiac phases at ECG-gated CT scan and ECG-gated radiotherapy beams delivery, for the same cardiac targets, will be done in terms of planned target coverage (target conformity index) and dose-volume histograms (DVH).
Measured: up to 3 years
Secondary outcomes (4)
Integration of ECGi Mapping into Planning CT for Target Contouring
To collect preliminary data of non-invasive electrocardiographic mapping (ECGi) usage for target definition in the setting of STAR, including the possibility of directly incorporating ECGi non-invasive mapping data into the planning CT to minimize potential mistakes in contouring the target.
Measured: up to 3 years
Feasibility and interferences of Ultrasound Probe on RT treatment planning
To verify the feasibility and possible interferences with simulated RT treatment planning of the use of an ultrasound probe (for online cardiac localization during beam delivery), positioned on the chest wall of patients during the imaging phase.
The feasibility will not be achieved in case the limited beam angles due to the probe position do not allow to achieve the dosimetric plan criteria outlined in table 1 in more than 10% of the enrolled patients.
Measured: up to 3 years
Development of Automatic Image Alignment
To develop and assess techniques for the automatic alignment of different images including CT and electroanatomic maps (EAM), to compose a single multimodal ventricular image where ablation planning can be more easily performed.
Measured: up to 3 years
Optimizing Arrhythmogenic Site Detection with Advanced Signal Processing Tools
To develop and assess techniques for the advanced simulation of the patient's ventricle by electrophysiological modelling customized on the EAM and the associated electrical information, to allow an in-silico test of the planned ablation strategy on a digital twin.
Optimal identification of arrhythmogenic sites will also be pursued by the adoption of novel signal and information processing tools that have already demonstrated to be effective in the local identification of abnormal ventricular potentials.
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start8 Feb 2022
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Collaborators
- CNAO National Center of Oncological Hadrontherapy, Pavia, Italy
- Responsible party
- Principal investigator, Roberto Rordorf, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07590908
- Sponsor's protocol ID
- CARA-VT
- Acronym
- CARA-VT
- Status last verified
- May 2026
- First submitted
- 14 Nov 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive CArdiac RAdioablation for Ventricular Tachycardia: a Feasibility Dosimetric in Silico Study Based on a Prospective Cohort of Patients to Compare Photon to Proton and to Carbon Ion Radiotherapy
- ClinicalTrials.gov ID
- NCT07590908
- Acronym / sponsor ID
- CARA-VT / CARA-VT
- Conditions
- Ventricular Tachycardia, Ventricular Arrhythmias
- Keywords
- Ventricular tachycardia, VT, Stereotactic arrhythmia radioablation, STAR, photons, carbon ions, particle therapy, radiation therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Collaborators
- CNAO National Center of Oncological Hadrontherapy, Pavia, Italy
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 15 May 2026 (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.
Ventricular tachycardia (VT) is a potentially deadly condition, common in patients with structural heart disease or dilated cardiomyopathy. VTpatients are currently treated with anti-arrhythmic drugs, implanted cardioverter defibrillators or invasive catheter ablation (CA) but the overall success rate of this techniqueis still suboptimal.
One of the main reasons is an anatomically inaccessible location of VT's origin (within the mid-wall of the myocardium, on the epicardial site or adjacent to critical structures). Moreover, repeated invasive ablation, technical difficulties or patient comorbidities can lead to non-eligibility for CA. Accordingly, a rationale exists to adopt more effective and less invasive therapies.
A promising novel non-invasive treatment option for refractory VT is stereotactic arrhythmia radio-ablation (STAR), originally born for cancer treatment, which consists in the application of high-energy photons in a single 25 Gy dose to limited areas of the ventricles, also to those inaccessible for CA, recognized through non-invasive surface ECG-mapping as the origin of VT. Preliminary small case series described good tolerance and improved VT burden during follow-up.
Due to the encouraging physical and biological characteristics of protons and carbon ions, the dose to surrounding healthy tissues could potentially be better spared in comparison with photons. Especially, the cardiac healthy sub-structures might benefit from the use of particle beams instead of photons. On the other hand, due to range uncertainties affecting particle beams, delivering an ideal radiation treatment with heavy ions to fast-moving targets such as the heart, is more complex. So far, the feasibility and the safety of cardiac radiotherapy with protons and heavy ions have only been evaluated in animal models and recently in the first in man case managed by the collaboration between CNAO and San Matteo Cardiology Department in a patient treated with compassionate aim.
To date, feasibility and safety data showing potential advantages of particles over photon therapy in dose distributions are missing.
Therefore, we propose a study aimed to compare different radiation therapy treatment modalities (photons vs. particle therapy: protons and carbon ions) simulating the RT treatment of ventricular arrhythmias on real patients candidates to invasive catheter ablation treatment.
STAR with photons was first reported in 2013 and an increasingly number of case reports and case series have been published ever since, showing an acceptable safety profile and promising efficacy.
Decreasing the dose to the surrounding healthy heart tissues is expected to be very advantageous for patients.
Particle therapy based on its dosimetric physical selectivity compared to SBRT (Stereotactic Body Radiotherapy) with photons might have the potential to both lower off-target doses and lower risk of possible side effects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photons (control group) | – | –"Stereotactic arrhythmia radioablation" (STAR) based on the delivery of a high, single dose (25 Gy) of photons to selected cardiac tissue (to limited areas of the ventricles), also to those inaccessible for CA, recognized through non-invasive surface ECG-mapping as the origin of VT. |
| Particle therapy with Protons and Carbon ions (Intervention group) | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Thirty patients suffering recurrent VT with clinical indication to receive invasive catheter ablation will be included in the study
Key inclusion criteria (4 listed)
- Recurrent VT with clinical indication to receive catheter ablation
- Written informed consent
- Patient's ability to understand the characteristics and consequences of the clinical study
- Invasive mapping data
Key exclusion criteria (3 listed)
- Allergy to iodinated contrast media
- Pregnancy and breastfeeding
- Younger than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility of particle therapy (protons and carbon ions)
Time frame: up to 3 years
To verify the feasibility of particle therapy plans in patients with refractory VT. Plans will be considered feasible whether the dosimetric criteria outlined will be achieved in no fewer than 90% of enrolled patients (30 enrolled patients).
Dose sparing on surrounding non-target tissues with particle therapy (protons and carbon ions)
Time frame: up to 3 years
To compare simulated RT plans with protons, carbon ions and photons, and quantify the differences in terms of dose released to surrounding cardiac and non-cardiac healthy tissues. Comparison of simulated RT plans, with protons, carbon ions and photons, by using cardiac motion management, optimizing the treatment plan on different cardiac phases at ECG-gated CT scan and ECG-gated radiotherapy beams delivery, for the same cardiac targets, will be done in terms of planned target coverage (target conformity index) and dose-volume histograms (DVH).
4 secondary outcomes
Integration of ECGi Mapping into Planning CT for Target Contouring
Time frame: up to 3 years
Feasibility and interferences of Ultrasound Probe on RT treatment planning
Time frame: up to 3 years
Development of Automatic Image Alignment
Time frame: up to 3 years
Optimizing Arrhythmogenic Site Detection with Advanced Signal Processing Tools
Time frame: up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Tachycardia and Ventricular Arrhythmias, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of particle therapy (protons and carbon ions) (time frame: up to 3 years). 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 15 May 2026.