Ventricular Tachycardia (VT)VT-ART-PNCT06922214
VT ART Consortium: Radioablation for Ventricular Tachycardia
A study testing Stereotactic Body Radiation Therapy (SBRT) in people with Ventricular Tachycardia (VT), run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The overall objective of the study is to evaluate the efficacy and safety of stereotactic radiation therapy in the non invasive ablation of ventricular tachycardia refractory to any other type treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia (VT)
- What is being tested?
- Stereotactic Body Radiation Therapy (SBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteItaly
- Study dates
- 26 Nov 2024to 31 Oct 2029
- 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
- Patients with refractory VT
- age > 18 years
- Patients with ICDs for follow-up
- Ineligible for heart transplantation.
- Prognosis of not less than 1 year
- Ability to express autonomous consent to therapies or (in case of inability due to clinical condition) deferred consent (first indicated by the referring clinician, later expressed by the patient once recovered to autonomous condition
Who cannot join
- Evaluation of ICD demonstrating polymorphic VT;
- Patients with INTERMACS class greater than 4;
- Patients with LVAD;
- Patients with active neoplastic disease undergoing oncological treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: VT-ART-P: Ventricular Tachycardia Ablation and RadioTherapy, a Prospective Study
The overall objective of the study is to evaluate the efficacy and safety of stereotactic radiation therapy in the non invasive ablation of ventricular tachycardia refractory to any other type treatment.
Read the detailed description
By agreeing to participate in this study, the patient will undergo an initial evaluation to verify that his or her condition meets the inclusion criteria required for participation. At that visit,
- 12-lead ECG will be performed
- Echocardiography
- CT scan of the chest
- Laboratory tests: NT proBNP, HS Troponin I
- PMK device evaluation The study will have a duration of 60 months and will involve 52 patients with the same disease from which one is affected. Specifically, the total expected duration of individual subject participation in the study will be 60 months.
Participation in the study does not involve any expense for the patient or any compensation.
Participation in the study may involve some risks such as :: pericarditis, actinic pneumonia, worsening heart failure, exitus.
The following benefits can be expected from participation in this study: reduction of VT episodes compared to the pre-treatment period, reduction/total discontinuation of antiarrhythmic drugs compared to baseline (before radioablation), improvement of cardiac parameters compared to baseline : LVEF, left ventricular end-diastolic volume/diameter, end-systolic volume/diameter, RVEF and TAPSE for right ventricular function, improvement of patient's quality of life (SF-36) compared to baseline. No direct benefits may also emerge from the study, but still significant for research.
- Conditions
- Ventricular Tachycardia (VT)
- Being tested
- Stereotactic Body Radiation Therapy (SBRT)
- Keywords
- Radioablation, Ventricular Tachycardia, STAR
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation Therapy (SBRT)Radiation
Also called Ventricular Radioablation
SBRT ( 25 Gy single fractions at isodose 80%) on the area responsible of ventricular tachicardia
| Study group | Role | What they receive |
|---|---|---|
| Refractory ventricular tachycardia patients | Experimental | Patients with refractory VT as defined above
1. age > 18 years
2. ICD patients for follow-up
3. Not eligible for heart transplantation.
4. Prognosis not less than 1 year.
They will have an initial assessment to verify that condition met the inclusion criteria required for participation, such as.It will be performed
* 12-lead ECG
* Echocardiography
* CT scan of the chest
* Laboratory analysis: NT proBNP, HS Troponin I
* PMK device evaluation and clinical ECG storage.
They will undergo stereotactic treatment on the arrhythmogenic cardiac site Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of VT episodes
The primary endpoint will be The reduction in VT episodes compared with the pre-treatment period as reported by ICD assessment at follow-up within 12 months after enrollment. The number of VT episodes during the last 3 months before treatment will be compared with the number of VT episodes recorded in a 3-month period after the 'blanking period' thus during the 4th, 5th and 6th months.
Measured: Starting from the week after treatment until 6 months later
Secondary outcomes (3)
Change in patient management
Reduction in VT episodes compared with the pre-treatment period as reported by ICD query in the shortest observational period. In more detail: the number of VT episodes in the last month before treatment will be compared with the number of VT episodes recorded in the third (3rd) month after treatment.
Measured: Starting from the week after treatment until 6 months later
Change in the dosage of antiarrhythmic drugs
Total reduction/suspension of antiarrhythmic drugs compared with baseline (before radiotherapy).
Measured: Starting from the week after treatment until 6 months later
Change in cardiac parameters
Improvement in cardiac parameters compared with baseline: LVEF, left ventricular diastolic volume
Measured: Starting from the week after treatment until 6 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start26 Nov 2024
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular Tachycardia (VT)Studies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CELLINI FRANCESCO, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Francesco Cellini, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922214
- Sponsor's protocol ID
- 0001221/24
- Acronym
- VT-ART-P
- Status last verified
- Mar 2025
- First submitted
- 26 Mar 2025
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VT-ART-P: Ventricular Tachycardia Ablation and RadioTherapy, a Prospective Study
- ClinicalTrials.gov ID
- NCT06922214
- Acronym / sponsor ID
- VT-ART-P / 0001221/24
- Conditions
- Ventricular Tachycardia (VT)
- Keywords
- Radioablation, Ventricular Tachycardia, STAR
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 26 Nov 2024 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2029 (estimated)
- First posted
- 10 Apr 2025 (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.
The overall objective of the study is to evaluate the efficacy and safety of stereotactic radiation therapy in the non invasive ablation of ventricular tachycardia refractory to any other type treatment.
Detailed description
By agreeing to participate in this study, the patient will undergo an initial evaluation to verify that his or her condition meets the inclusion criteria required for participation. At that visit,
- 12-lead ECG will be performed
- Echocardiography
- CT scan of the chest
- Laboratory tests: NT proBNP, HS Troponin I
- PMK device evaluation The study will have a duration of 60 months and will involve 52 patients with the same disease from which one is affected. Specifically, the total expected duration of individual subject participation in the study will be 60 months.
Participation in the study does not involve any expense for the patient or any compensation.
Participation in the study may involve some risks such as :: pericarditis, actinic pneumonia, worsening heart failure, exitus.
The following benefits can be expected from participation in this study: reduction of VT episodes compared to the pre-treatment period, reduction/total discontinuation of antiarrhythmic drugs compared to baseline (before radioablation), improvement of cardiac parameters compared to baseline : LVEF, left ventricular end-diastolic volume/diameter, end-systolic volume/diameter, RVEF and TAPSE for right ventricular function, improvement of patient's quality of life (SF-36) compared to baseline. No direct benefits may also emerge from the study, but still significant for research.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Refractory ventricular tachycardia patients | Experimental | Radiation: Stereotactic Body Radiation Therapy (SBRT)Patients with refractory VT as defined above 1. age > 18 years 2. ICD patients for follow-up 3. Not eligible for heart transplantation. 4. Prognosis not less than 1 year. They will have an initial assessment to verify that condition met the inclusion criteria required for participation, such as.It will be performed * 12-lead ECG * Echocardiography * CT scan of the chest * Laboratory analysis: NT proBNP, HS Troponin I * PMK device evaluation and clinical ECG storage. They will undergo stereotactic treatment on the arrhythmogenic cardiac site |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with refractory VT
- age > 18 years
- Patients with ICDs for follow-up
- Ineligible for heart transplantation.
- Prognosis of not less than 1 year
Key exclusion criteria (4 listed)
- Evaluation of ICD demonstrating polymorphic VT;
- Patients with INTERMACS class greater than 4;
- Patients with LVAD;
- Patients with active neoplastic disease undergoing oncological treatment.
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 |
|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT)Also: Ventricular RadioablationSBRT ( 25 Gy single fractions at isodose 80%) on the area responsible of ventricular tachicardia | Radiation | Refractory ventricular tachycardia patients |
Primary outcome
Change in the number of VT episodes
Time frame: Starting from the week after treatment until 6 months later
The primary endpoint will be The reduction in VT episodes compared with the pre-treatment period as reported by ICD assessment at follow-up within 12 months after enrollment. The number of VT episodes during the last 3 months before treatment will be compared with the number of VT episodes recorded in a 3-month period after the 'blanking period' thus during the 4th, 5th and 6th months.
3 secondary outcomes
Change in patient management
Time frame: Starting from the week after treatment until 6 months later
Change in the dosage of antiarrhythmic drugs
Time frame: Starting from the week after treatment until 6 months later
Change in cardiac parameters
Time frame: Starting from the week after treatment until 6 months later
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 11 May 2025.
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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.
Francesco Cellini principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Body Radiation Therapy (SBRT) in people with Ventricular Tachycardia (VT), run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 6 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 11 May 2025. 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?
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?
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?
Change in the number of VT episodes (time frame: Starting from the week after treatment until 6 months later). 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 11 May 2025.