Using advanced imaging for targeted radiation therapy in heart rhythm disorders
STereotactic RadioAblation by Multimodal Imaging for VT (STRA-MI-VT)
This study is testing a new type of radiation therapy guided by advanced heart imaging to see if it can help patients with hard-to-treat heart rhythm problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Centro Cardiologico Monzino Academic / other |
| Locations | 2 sites (Milano, MI and 1 other locations) |
| Trial ID | NCT04066517 on ClinicalTrials.gov |
What this trial studies
The STRA-MI-VT study evaluates the safety and efficacy of stereotactic body radiotherapy (SBRT) guided by multimodal cardiac imaging for patients with refractory ventricular tachycardia (VT). This open-label, prospective clinical trial aims to create tailored treatment plans using electroanatomic mapping and various linear accelerators. It focuses on patients who are not candidates for conventional catheter ablation or have previously failed such treatments. The study seeks to provide a new therapeutic option for this challenging condition.
Who should consider this trial
Good fit: Ideal candidates include patients aged 50 and older with refractory VT who have received an ICD or S-ICD and are not suitable for conventional ablation.
Not a fit: Patients with active myocardial ischemia, recent acute revascularization, or serious comorbidities with a life expectancy of less than 12 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a novel treatment option for patients with refractory VT who have limited alternatives.
How similar studies have performed: While the use of SBRT for cardiac conditions is emerging, this specific multimodal imaging approach is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Milano, MI and 1 other locations
- Centro Cardiologico Monzino, IRCCS — Milano, Mi, Italy (Recruiting)
- Istituto Europeo di Oncologia, IRCCS — Milano, Mi, Italy (Active_not_recruiting)
Study contacts
- Study coordinator: Corrado Carbucicchio, MD
- Email: corrado.carbucicchio@ccfm.it
- Phone: +39 02 58001626
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.