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

NCT ID: NCT04066517

Last Updated: 2023-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-13

Study Completion Date

2025-06-13

Brief Summary

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

Detailed Description

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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

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Refractory Ventricular Tachycardia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

No masking in this study.

Study Groups

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Open Label

Non-randomized, open label clinical trial that intends to treat with SBRT 15 patients with refractory VT.

Group Type EXPERIMENTAL

SBRT

Intervention Type PROCEDURE

Multimodal-imaging guided SBRT for VT ablation.

Interventions

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SBRT

Multimodal-imaging guided SBRT for VT ablation.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Europeo di Oncologia

OTHER

Sponsor Role collaborator

Centro Cardiologico Monzino

OTHER

Sponsor Role lead

Responsible Party

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Corrado Carbucicchio

Head of Ventricular Intensive Care Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Centro Cardiologico Monzino, IRCCS

Milan, MI, Italy

Site Status RECRUITING

Istituto Europeo di Oncologia, IRCCS

Milan, MI, Italy

Site Status ACTIVE_NOT_RECRUITING

Countries

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Italy

Central Contacts

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Corrado Carbucicchio, MD

Role: CONTACT

+39 02 58001626

Valentina Catto, PhD

Role: CONTACT

+39 02 58002856

Facility Contacts

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Corrado Carbucicchio, MD

Role: primary

+39 02 58001626

Valentina Catto, PhD

Role: backup

+39 02 58002856

References

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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.

Reference Type BACKGROUND
PMID: 32851578 (View on PubMed)

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, 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.

Reference Type BACKGROUND
PMID: 34609691 (View on PubMed)

Other Identifiers

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R 918/19 - CCM968

Identifier Type: -

Identifier Source: org_study_id

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