STereotactic RadioAblation by Multimodal Imaging for VT (STRA-MI-VT)

Centro Cardiologico Monzino

Status

Enrolling

Conditions

Refractory Ventricular Tachycardia

Treatments

Procedure: SBRT

Study type

Interventional

Funder types

Other

Identifiers

NCT04066517

R 918/19 - CCM968

Details and patient eligibility

About

Study of multimodal-imaging guided stereotactic body radiotherapy (SBRT) for ventricular tachycardia (VT) ablation.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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.