Refractory Ventricular TachycardiaSTRA-MI-VTNCT04066517
STereotactic RadioAblation by Multimodal Imaging for VT (STRA-MI-VT)
A study testing SBRT in people with Refractory Ventricular Tachycardia, run by Centro Cardiologico Monzino at 2 sites in Italy.
Trial summary
Study of multimodal-imaging guided stereotactic body radiotherapy (SBRT) for ventricular tachycardia (VT) ablation. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Refractory Ventricular Tachycardia
- What is being tested?
- SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesItaly
- Study dates
- 13 Sep 2019to 13 Jun 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ICD/S-ICD recipients with refractory VT
- Not eligible for conventional catheter ablation or -in alternative- that have undergone failing conventional catheter ablation attempts, refusing surgery for the treatment of the arrhythmia.
- LVEF ≥ 20%.
- Age ≥ 50 years.
- Signed an IRB approved written informed consent document.
Who cannot join
- Previous radiotherapy with cardiac involvement.
- Pregnancy or breastfeeding.
- Active myocardial ischemia.
- Acute revascularation in the past 120 days.
- Acute hemodynamic instability (cardiogenic shock/NYHA IV).
- Serious disease with presumed life expectancy less than 12 months.
- Any condition that is deemed a contraindication in the judgment of the investigators.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 1 recruiting
- Recruiting
Centro Cardiologico Monzino, IRCCS
Milan, MI, 20138
Corrado Carbucicchio, MD, +39 02 58001626, corrado.carbucicchio@ccfm.it
Valentina Catto, PhD, +39 02 58002856, valentina.catto@ccfm.it
- Active, not recruiting
Istituto Europeo di Oncologia, IRCCS
Milan, MI, 20141
About this study
Study of multimodal-imaging guided stereotactic body radiotherapy (SBRT) for ventricular tachycardia (VT) ablation.
Read the detailed description
STRA-MI-VT study is a spontaneous, open-label, not randomized, prospective clinical trial.
The objective of the study is to evaluate the safety and efficacy of SBRT in strictly selected patients with refractory VT.
Multimodal cardiac imaging combined with electroanatomic mapping to provide a specific patient's tailored SBRT treatment plan choosing amang different linear accelerators.
- Conditions
- Refractory Ventricular Tachycardia
- Being tested
- 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.
SBRTProcedure or surgery
Multimodal-imaging guided SBRT for VT ablation.
| Study group | Role | What they receive |
|---|---|---|
| Open Label | Experimental | Non-randomized, open label clinical trial that intends to treat with SBRT 15 patients with refractory VT. Receives: Procedure: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
SBRT safety during 12 month follow-up
Serious adverse events will be defined using CTCAE v4.0 criteria.
Measured: 12 months
SBRT efficacy based on reduction of VT episodes during 12 month follow-up
There will be 6 week blanking period after therapy to allow for ablation effect
Measured: 12 months
Secondary outcomes (3)
Total mortality
Measured: 12 months
Health related quality of life
Health related quality of life for positive or negative changes based on score from SF-36 Questionnaire
Measured: 12 months
Cardiac functional changes
Cardiac functional changes evaluated by echocardiography ejection fraction
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start13 Sep 2019
- Primary completion13 Jun 2025 (estimated)
- Study completion13 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Europeo di Oncologia
- Responsible party
- Principal investigator, Corrado Carbucicchio, Centro Cardiologico Monzino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04066517
- Sponsor's protocol ID
- R 918/19 - CCM968
- Acronym
- STRA-MI-VT
- Status last verified
- Sep 2023
- First submitted
- 24 Jul 2019
- Last updated
- 13 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Carbucicchio C, Jereczek-Fossa BA, Andreini D, Catto V, Piperno G, Conte E, Cattani F, Rondi E, Vigorito S, Piccolo C, Bonomi A, Gorini A, Pepa M, Mushtaq S, Fassini G, Moltrasio M, Tundo F, Marvaso G, Veglia F, Orecchia R, Tremoli E, Tondo C. STRA-MI-VT (STereotactic RadioAblation by Multimodal Imaging for Ventricular Tachycardia): rationale and design of an Italian experimental prospective study. J Interv Card Electrophysiol. 2021 Sep;61(3):583-593. doi: 10.1007/s10840-020-00855-2. Epub 2020 Aug 27.
PubMed 32851578Carbucicchio C, Andreini D, Piperno G, Catto V, Conte E, Cattani F, Bonomi A, Rondi E, Piccolo C, Vigorito S, Ferrari A, Pepa M, Giuliani M, Mushtaq S, Scara A, Calo L, Gorini A, Veglia F, Pontone G, Pepi M, Tremoli E, Orecchia R, Pompilio G, Tondo C, Jereczek-Fossa BA. Stereotactic radioablation for the treatment of ventricular tachycardia: preliminary data and insights from the STRA-MI-VT phase Ib/II study. J Interv Card Electrophysiol. 2021 Nov;62(2):427-439. doi: 10.1007/s10840-021-01060-5. Epub 2021 Oct 5.
PubMed 34609691
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STereotactic RadioAblation by Multimodal Imaging for VT (STRA-MI-VT)
- ClinicalTrials.gov ID
- NCT04066517
- Acronym / sponsor ID
- STRA-MI-VT / R 918/19 - CCM968
- Conditions
- Refractory Ventricular Tachycardia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or other
- Collaborators
- Istituto Europeo di Oncologia
- Study start
- 13 Sep 2019 (actual)
- Primary completion
- 13 Jun 2025 (estimated)
- Study completion
- 13 Jun 2025 (estimated)
- First posted
- 26 Aug 2019 (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.
Study of multimodal-imaging guided stereotactic body radiotherapy (SBRT) for ventricular tachycardia (VT) ablation.
Detailed description
STRA-MI-VT study is a spontaneous, open-label, not randomized, prospective clinical trial.
The objective of the study is to evaluate the safety and efficacy of SBRT in strictly selected patients with refractory VT.
Multimodal cardiac imaging combined with electroanatomic mapping to provide a specific patient's tailored SBRT treatment plan choosing amang different linear accelerators.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label | Experimental | Procedure: SBRTNon-randomized, open label clinical trial that intends to treat with SBRT 15 patients with refractory VT. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ICD/S-ICD recipients with refractory VT
- Not eligible for conventional catheter ablation or -in alternative- that have undergone failing conventional catheter ablation attempts, refusing surgery for the treatment of the arrhythmia.
- LVEF ≥ 20%.
- Age ≥ 50 years.
- Signed an IRB approved written informed consent document.
Key exclusion criteria (7 listed)
- Previous radiotherapy with cardiac involvement.
- Pregnancy or breastfeeding.
- Active myocardial ischemia.
- Acute revascularation in the past 120 days.
- Acute hemodynamic instability (cardiogenic shock/NYHA IV).
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 |
|---|---|---|
| SBRTMultimodal-imaging guided SBRT for VT ablation. | Procedure or surgery | Open Label |
Primary outcome
SBRT safety during 12 month follow-up
Time frame: 12 months
Serious adverse events will be defined using CTCAE v4.0 criteria.
SBRT efficacy based on reduction of VT episodes during 12 month follow-up
Time frame: 12 months
There will be 6 week blanking period after therapy to allow for ablation effect
3 secondary outcomes
Total mortality
Time frame: 12 months
Health related quality of life
Time frame: 12 months
Cardiac functional changes
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Background: PubMed 32851578Carbucicchio C, Jereczek-Fossa BA, Andreini D, Catto V, Piperno G, Conte E, Cattani F, Rondi E, Vigorito S, Piccolo C, Bonomi A, Gorini A, Pepa M, Mushtaq S, Fassini G, Moltrasio M, Tundo F, Marvaso G, Veglia F, Orecchia R, Tremoli E, Tondo C. STRA-MI-VT (STereotactic RadioAblation by Multimodal Imaging for Ventricular Tachycardia): rationale and design of an Italian experimental prospective study. J Interv Card Electrophysiol. 2021 Sep;61(3):583-593. doi: 10.1007/s10840-020-00855-2. Epub 2020 Aug 27.
- Background: PubMed 34609691Carbucicchio C, Andreini D, Piperno G, Catto V, Conte E, Cattani F, Bonomi A, Rondi E, Piccolo C, Vigorito S, Ferrari A, Pepa M, Giuliani M, Mushtaq S, Scara A, Calo L, Gorini A, Veglia F, Pontone G, Pepi M, Tremoli E, Orecchia R, Pompilio G, Tondo C, Jereczek-Fossa BA. Stereotactic radioablation for the treatment of ventricular tachycardia: preliminary data and insights from the STRA-MI-VT phase Ib/II study. J Interv Card Electrophysiol. 2021 Nov;62(2):427-439. doi: 10.1007/s10840-021-01060-5. Epub 2021 Oct 5.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SBRT in people with Refractory Ventricular Tachycardia, run by Centro Cardiologico Monzino at 2 sites 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 5 inclusion and 7 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 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Corrado Carbucicchio, MD (+39 02 58001626, corrado.carbucicchio@ccfm.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SBRT safety during 12 month follow-up (time frame: 12 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?
On the ClinicalTrials.gov record for NCT04066517, which also lists 2 linked publications.
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 13 Sep 2023.