Ventricular Tachycardia (VT)VT-ART RNCT06990139
Ventricular Tachycardia Ablation Through Radiation Therapy Consortium: Concept Description of an Observational Retrospective Multicentric Trial
An observational study of Ventricular Tachycardia (VT), run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Recurrent ventricular tachycardia (VT) is a potentially life-threatening arrhythmia in patients with structural heart disease. Despite the use of antiarrhythmic drugs, implantable cardioverter-defibrillators (ICDs), and radiofrequency catheter ablation, VT recurrence rates remain high-reaching up to 66% in some… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia (VT)
- How many people
- 149 participants
- Where
- 1 siteItaly
- Study dates
- 30 Mar 2025to 30 Mar 2029
- Phase
- Observational
- 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
Study population: Patients presenting at Fondazione Policlinico Gemelli IRCCS and in all centers that joined the protocol
Who may be able to join
- Diagnosis of refractory ventricular tachycardia (VT), as previously defined
- Age greater than 18 years
- Presence of an implantable cardioverter-defibrillator (ICD) for follow-up
- Not eligible for heart transplantation
- Estimated life expectancy of at least 1 year
- Ability to provide autonomous, informed consent to participate in the study
Who cannot join
- ICD interrogation demonstrating polymorphic VT
- Patients with INTERMACS class more than 4
- Patients with LVADs
- Patients with active neoplastic disease under oncological treatment
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo Francesco Vito 1, 00168, Rome (Italy)
Rome, ROME, 00168
About this study
Official title: Ventricular Tachycardia Ablation Through Radiation Therapy Consortium: Concept Description of an Observational Retrospective Multicentric Trial Via Matched Pair Analysis (VT-ARTr)
Recurrent ventricular tachycardia (VT) is a potentially life-threatening arrhythmia in patients with structural heart disease. Despite the use of antiarrhythmic drugs, implantable cardioverter-defibrillators (ICDs), and radiofrequency catheter ablation, VT recurrence rates remain high-reaching up to 66% in some series. For patients with refractory VT who are not candidates for further ablation or surgical interventions, there is a significant unmet need for novel, effective, and non-invasive treatment options.
Stereotactic body radiation therapy (SBRT) has recently emerged as a promising approach for treating ventricular arrhythmias through a technique known as stereotactic arrhythmia radioablation (STAR). Preliminary studies, including a phase I/II clinical trial, have demonstrated a substantial reduction in VT burden-up to 99.9%-following treatment, with an acceptable safety profile. Reported adverse events have included manageable pericardial effusion, radiation-induced pericarditis, and pneumonitis. The growing body of evidence supports STAR as a feasible and effective alternative for selected patients with treatment-resistant VT.
Read more
The objective of this study is to evaluate the efficacy and safety of stereotactic radiotherapy as a non-invasive ablation technique for the treatment of ventricular tachycardia (VT) in patients with refractory arrhythmias in whom conventional therapies have failed.
This is a retrospective observational study aimed at comparing outcomes between patients who received stereotactic radioablation and those who did not. A matched-pair analysis will be used to adjust for baseline clinical characteristics and ensure comparability between groups.
- Conditions
- Ventricular Tachycardia (VT)
- Keywords
- ventricular tachycardia, radioablation
- 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 |
|---|---|---|
| patients who have undergone SBRT | Within this group we find patients who have had all possible canonical treatments for the arrhythmia and also the stereotactic radiation treatment | |
| patients who have not undergone SBRT | Within this group we find patients who have had all possible canonical treatments for the arrhythmia, but not the stereotactic radiation treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in VT episode frequency compared to the pretreatment period
The number of VT episodes during the 3 months prior to treatment will be compared to the number of episodes recorded during the 3-month period following the post-treatment blanking period. This comparison will help determine whether the treatment provides clinical benefits even at an early stage
Measured: Starting from three months before treatment until 3 months later
Secondary outcomes (3)
Change in antiarrhythmic drug burden compared to the baseline
The study aims to show whether radioablation treatment is associated with a significant reduction in the use of antiarrhythmic drugs compared to patients who did not undergo the procedure
Measured: 36 months
Change in left ventricular end-diastolic volume compared to the baseline
Improvement in left ventricular end-diastolic volume, as assessed through specific tests performed by a cardiologist specializing in arrhythmology, especially the Echocardiogram, and a global electrophysiological evaluation
Measured: 36 months
Change in left ventricular end-systolic volume compared to the baseline
Improvement in left ventricular end-systolic volume , as assessed through specific tests performed by a cardiologist specializing in arrhythmology , especially the Echocardiogram, and a global electrophysiological evaluation
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start30 Mar 2025
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Mar 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CELLINI FRANCESCO, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06990139
- Sponsor's protocol ID
- 0001344/24
- Acronym
- VT-ART R
- Status last verified
- Apr 2025
- First submitted
- 23 Apr 2025
- Last updated
- 25 May 2025
- 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 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventricular Tachycardia Ablation Through Radiation Therapy Consortium: Concept Description of an Observational Retrospective Multicentric Trial Via Matched Pair Analysis (VT-ARTr)
- ClinicalTrials.gov ID
- NCT06990139
- Acronym / sponsor ID
- VT-ART R / 0001344/24
- Conditions
- Ventricular Tachycardia (VT)
- Keywords
- ventricular tachycardia, radioablation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 30 Mar 2025 (actual)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 25 May 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.
Recurrent ventricular tachycardia (VT) is a potentially life-threatening arrhythmia in patients with structural heart disease. Despite the use of antiarrhythmic drugs, implantable cardioverter-defibrillators (ICDs), and radiofrequency catheter ablation, VT recurrence rates remain high-reaching up to 66% in some series. For patients with refractory VT who are not candidates for further ablation or surgical interventions, there is a significant unmet need for novel, effective, and non-invasive treatment options.
Stereotactic body radiation therapy (SBRT) has recently emerged as a promising approach for treating ventricular arrhythmias through a technique known as stereotactic arrhythmia radioablation (STAR). Preliminary studies, including a phase I/II clinical trial, have demonstrated a substantial reduction in VT burden-up to 99.9%-following treatment, with an acceptable safety profile. Reported adverse events have included manageable pericardial effusion, radiation-induced pericarditis, and pneumonitis. The growing body of evidence supports STAR as a feasible and effective alternative for selected patients with treatment-resistant VT.
The objective of this study is to evaluate the efficacy and safety of stereotactic radiotherapy as a non-invasive ablation technique for the treatment of ventricular tachycardia (VT) in patients with refractory arrhythmias in whom conventional therapies have failed.
This is a retrospective observational study aimed at comparing outcomes between patients who received stereotactic radioablation and those who did not. A matched-pair analysis will be used to adjust for baseline clinical characteristics and ensure comparability between groups.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients who have undergone SBRT | – | –Within this group we find patients who have had all possible canonical treatments for the arrhythmia and also the stereotactic radiation treatment |
| patients who have not undergone SBRT | – | –Within this group we find patients who have had all possible canonical treatments for the arrhythmia, but not the stereotactic radiation treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting at Fondazione Policlinico Gemelli IRCCS and in all centers that joined the protocol
Key inclusion criteria (6 listed)
- Diagnosis of refractory ventricular tachycardia (VT), as previously defined
- Age greater than 18 years
- Presence of an implantable cardioverter-defibrillator (ICD) for follow-up
- Not eligible for heart transplantation
- Estimated life expectancy of at least 1 year
Key exclusion criteria (4 listed)
- ICD interrogation demonstrating polymorphic VT
- Patients with INTERMACS class more than 4
- Patients with LVADs
- Patients with active neoplastic disease under 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.
Primary outcome
Change in VT episode frequency compared to the pretreatment period
Time frame: Starting from three months before treatment until 3 months later
The number of VT episodes during the 3 months prior to treatment will be compared to the number of episodes recorded during the 3-month period following the post-treatment blanking period. This comparison will help determine whether the treatment provides clinical benefits even at an early stage
3 secondary outcomes
Change in antiarrhythmic drug burden compared to the baseline
Time frame: 36 months
Change in left ventricular end-diastolic volume compared to the baseline
Time frame: 36 months
Change in left ventricular end-systolic volume compared to the baseline
Time frame: 36 months
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 25 May 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Ventricular Tachycardia (VT)
Recruiting
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)
Tachycardia, Ventricular
Not yet recruiting
MRI-guided Ventricular Tachycardia Ablation in Patients With Structural Heart Disease
Ventricular Tachycardia (VT), Ischemic Cardiomyopathy
Recruiting
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Ventricular Tachycardia
Not yet recruiting
Head-to-Head (H2H) Comparison of Ambulatory Cardiac ECG Monitors in Japan
Atrial Fibrillation (AF), Atrial Flutter
Active, not recruitingObservational study
Evolution of Intracardiac Electrograms Recorded by Left Bundle Branch Pacing Lead in Patients With ICD or CRT-D
Ventricular Tachycardia (VT), Ventricular Fibrillation
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 (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 25 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 VT episode frequency compared to the pretreatment period (time frame: Starting from three months before treatment until 3 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 25 May 2025.