Refractory Ventricular TachycardiaPOPSTARNCT06294782
PrOsPective Cohort Study for STereotactic Arhythmia Radioablation (STAR) of Refractory Ventricular Tachycardia
A study testing STereotactic Arhythmia Radioablation (STAR) in people with Refractory Ventricular Tachycardia, run by University of Turin, Italy at 1 site in Italy.
Trial summary
This is a multicenter, interventional study. The study will enroll patients that fulfill the inclusion criteria over a 33-month period. Considering the small number of patients who will meet the study criteria, it is also possible to include retrospective patients who already underwent STAR (for instance, as part of a… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Refractory Ventricular Tachycardia
- What is being tested?
- STereotactic Arhythmia Radioablation (STAR)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 15 Apr 2022to Feb 2025
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Structural heart disease (SHD) defined as left ventricular dysfunction (LVEF < 55%), or right ventricular dysfunction (FAC <35%) or presence of ventricular scar, pathological hypertrophy, wall bulging or inflammatory conditions.
- Optimized medical treatment for the underlying SHD
- ICD or CRT-D recipient
- ≥ 1 episodes of sustained or treated (with either anti-tachycardia pacing or shock, internal or external) monomorphic VT (MMVT) resistant to at least one invasive VT ablation attempt, unless contraindicated or deemed at high risk. Reason for lack of ablation must be specified
Who cannot join
- Age < 18 or > 85 years.
- Inability to provide informed consent.
- Acute myocardial infarction or recent primary coronary intervention or cardiac surgery (<3 months)
- Primary electrical disease (e.g. long QT syndrome, short QT syndrome, catecholaminergic polymorphic ventricular tachycardia, Brugada syndrome).
- Reversible and/or treatable cause of VT (e.g., drug-induced or intoxication)
- ICD electrode malfunction or ICD readings outside reference range
- Pregnancy or breast feeding
- Patients with polymorphic VT/VF
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Turin
Turin
Gaetano Maria De Ferrari
About this study
This is a multicenter, interventional study. The study will enroll patients that fulfill the inclusion criteria over a 33-month period. Considering the small number of patients who will meet the study criteria, it is also possible to include retrospective patients who already underwent STAR (for instance, as part of a compassionate program) if they meet all the inclusion and exclusion criteria as well as the treatment planning standardized requirements and sign their consent to this trial. All patients prospectively enrolled will undergo a flow of investigations following a standardized approach. ICD programming will be standardized.
- Conditions
- Refractory Ventricular Tachycardia
- Being tested
- STereotactic Arhythmia Radioablation (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 Arhythmia Radioablation (STAR)Radiation
STereotactic Arhythmia Radioablation (STAR)
| Study group | Role | What they receive |
|---|---|---|
| STereotactic Arhythmia Radioablation (STAR) | Experimental | Patients fulfilling the inclusion and exclusion criteria will undergo (or already underwent) a single-session 25 Gy STAR for the treatment of refractory monomorphic VT. Receives: Radiation: STereotactic Arhythmia Radioablation (STAR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
VT storm and incessant VT
6-month survival free from VT storm (3 or more episodes or sustained or treated VT within 24 hours) and incessant VT (binary endpoint), including an initial blanking period of 8 weeks.
Measured: 6 months
adverse events
: measured by registered adverse events using the CTCAE v5 system, 'early' (up to 30 days), 'intermediate' (30-90 days), and 'late' (>90 days after treatment). The extensive mandatory and optional follow-up examinations provide the basis for detecting these adverse events.
Measured: 33 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start15 Apr 2022
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda USL Reggio Emilia - IRCCS, IRCCS Sacro Cuore Don Calabria di Negrar, Fondazione IRCCS Policlinico San Matteo di Pavia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294782
- Sponsor's protocol ID
- 36/2022
- Acronym
- POPSTAR
- Status last verified
- Mar 2024
- First submitted
- 10 May 2022
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PrOsPective Cohort Study for STereotactic Arhythmia Radioablation (STAR) of Refractory Ventricular Tachycardia
- ClinicalTrials.gov ID
- NCT06294782
- Acronym / sponsor ID
- POPSTAR / 36/2022
- Conditions
- Refractory Ventricular Tachycardia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Collaborators
- Azienda USL Reggio Emilia - IRCCS, IRCCS Sacro Cuore Don Calabria di Negrar, Fondazione IRCCS Policlinico San Matteo di Pavia
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 6 Mar 2024 (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.
This is a multicenter, interventional study. The study will enroll patients that fulfill the inclusion criteria over a 33-month period. Considering the small number of patients who will meet the study criteria, it is also possible to include retrospective patients who already underwent STAR (for instance, as part of a compassionate program) if they meet all the inclusion and exclusion criteria as well as the treatment planning standardized requirements and sign their consent to this trial. All patients prospectively enrolled will undergo a flow of investigations following a standardized approach. ICD programming will be standardized.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STereotactic Arhythmia Radioablation (STAR) | Experimental | Radiation: STereotactic Arhythmia Radioablation (STAR)Patients fulfilling the inclusion and exclusion criteria will undergo (or already underwent) a single-session 25 Gy STAR for the treatment of refractory monomorphic VT. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Structural heart disease (SHD) defined as left ventricular dysfunction (LVEF < 55%), or right ventricular dysfunction (FAC <35%) or presence of ventricular scar, pathological hypertrophy, wall bulging or inflammatory conditions.
- Optimized medical treatment for the underlying SHD
- ICD or CRT-D recipient
- ≥ 1 episodes of sustained or treated (with either anti-tachycardia pacing or shock, internal or external) monomorphic VT (MMVT) resistant to at least one invasive VT ablation attempt, unless contraindicated or deemed at high risk. Reason for lack of ablation must be specified
Key exclusion criteria (8 listed)
- Age < 18 or > 85 years.
- Inability to provide informed consent.
- Acute myocardial infarction or recent primary coronary intervention or cardiac surgery (<3 months)
- Primary electrical disease (e.g. long QT syndrome, short QT syndrome, catecholaminergic polymorphic ventricular tachycardia, Brugada syndrome).
- Reversible and/or treatable cause of VT (e.g., drug-induced or intoxication)
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 Arhythmia Radioablation (STAR)STereotactic Arhythmia Radioablation (STAR) | Radiation | STereotactic Arhythmia Radioablation (STAR) |
Primary outcome
VT storm and incessant VT
Time frame: 6 months
6-month survival free from VT storm (3 or more episodes or sustained or treated VT within 24 hours) and incessant VT (binary endpoint), including an initial blanking period of 8 weeks.
adverse events
Time frame: 33 months
: measured by registered adverse events using the CTCAE v5 system, 'early' (up to 30 days), 'intermediate' (30-90 days), and 'late' (>90 days after treatment). The extensive mandatory and optional follow-up examinations provide the basis for detecting these adverse events.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
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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.
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 Arhythmia Radioablation (STAR) in people with Refractory Ventricular Tachycardia, run by University of Turin, Italy 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 8 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: status not confirmed, as of the sponsor's last update on 6 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gaetano Maria De Ferrari, MD (+390116336022, gaetanomariadeferrari@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VT storm and incessant VT (time frame: 6 months). 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 6 Mar 2024; AzTrials last refreshed its copy on 7 Nov 2026.