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

Conditions

Refractory Ventricular Tachycardia

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 refractory VT. Multimodal cardiac imaging combined with electroanatomic mapping to provide a specific patient's tailored SBRT treatment plan choosing amang different linear accelerators.

Piccolo C, Vigorito S, Rondi E, Piperno G, Ferrari A, Pepa M, Riva G, Durante S, Conte E, Catto V, Andreini D, Carbucicchio C, Jereczek-Fossa BA, Pompilio G, Orecchia R, Cattani F.

2022-07-092 citations

10.1016/j.ejmp.2022.06.019

Stereotactic radioablation for the treatment of ventricular tachycardia: preliminary data and insights from the STRA-MI-VT phase Ib/II study.

Carbucicchio 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, Scarà A, Calò L, Gorini A, Veglia F, Pontone G, Pepi M, Tremoli E, Orecchia R, Pompilio G, Tondo C, Jereczek-Fossa BA.

2021-10-0547 citations

10.1007/s10840-021-01060-5

STRA-MI-VT (STereotactic RadioAblation by Multimodal Imaging for Ventricular Tachycardia): rationale and design of an Italian experimental prospective study.

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.

2020-08-2715 citations

10.1007/s10840-020-00855-2

Radiosurgery for ventricular tachycardia: preclinical and clinical evidence and study design for a German multi-center multi-platform feasibility trial (RAVENTA)

Oliver Blanck, Daniel Buergy, Maren Vens, Lina Eidinger, Adrian Zaman et al. (19 authors)

Clinical Research in Cardiology2020-04-1869 citations

10.1007/s00392-020-01650-9

Interventions

PROCEDURESBRT

Multimodal-imaging guided SBRT for VT ablation.

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Masking description

No masking in this study.

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	Time frame	Description
SBRT safety during 12 month follow-up	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	12 months	There will be 6 week blanking period after therapy to allow for ablation effect

Secondary

Measure	Time frame	Description
Total mortality	12 months	—
Health related quality of life	12 months	Health related quality of life for positive or negative changes based on score from SF-36 Questionnaire
Cardiac functional changes	12 months	Cardiac functional changes evaluated by echocardiography ejection fraction

Countries

Italy

Contacts

Primary ContactCorrado Carbucicchio, MD

corrado.carbucicchio@ccfm.it+39 02 58001626

Backup ContactValentina Catto, PhD

valentina.catto@ccfm.it+39 02 58002856

Outcome results

None listed