Status:
UNKNOWN
STereotactic RadioAblation by Multimodal Imaging for VT (STRA-MI-VT)
Lead Sponsor:
Centro Cardiologico Monzino
Collaborating Sponsors:
Istituto Europeo di Oncologia
Conditions:
Refractory Ventricular Tachycardia
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 13 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04066517
Start Date
September 13 2019
End Date
June 13 2025
Last Update
September 13 2023
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Centro Cardiologico Monzino, IRCCS
Milan, MI, Italy, 20138
2
Istituto Europeo di Oncologia, IRCCS
Milan, MI, Italy, 20141