NCT04066517

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 26, 2019

Completed
18 days until next milestone

Study Start

First participant enrolled

September 13, 2019

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2025

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

5.8 years

First QC Date

July 24, 2019

Last Update Submit

September 11, 2023

Conditions

Refractory Ventricular Tachycardia

Outcome Measures

Primary Outcomes (2)

  • SBRT safety during 12 month follow-up

    Serious adverse events will be defined using CTCAE v4.0 criteria.

    12 months

  • SBRT efficacy based on reduction of VT episodes during 12 month follow-up

    There will be 6 week blanking period after therapy to allow for ablation effect

    12 months

Secondary Outcomes (3)

  • Total mortality

    12 months

  • Health related quality of life

    12 months

  • Cardiac functional changes

    12 months

Study Arms (1)

Open Label

EXPERIMENTAL

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

Procedure: SBRT

Interventions

SBRTPROCEDURE

Multimodal-imaging guided SBRT for VT ablation.

Open Label

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centro Cardiologico Monzino, IRCCS

Milan, MI, 20138, Italy

RECRUITING

Istituto Europeo di Oncologia, IRCCS

Milan, MI, 20141, Italy

ACTIVE NOT RECRUITING

Related Publications (2)

  • 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.

    PMID: 32851578BACKGROUND

  • 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.

    PMID: 34609691BACKGROUND

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Corrado Carbucicchio, MD

CONTACT

+39 02 58001626corrado.carbucicchio@ccfm.it

Valentina Catto, PhD

CONTACT

+39 02 58002856valentina.catto@ccfm.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
No masking in this study.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Ventricular Intensive Care Unit

Study Record Dates

First Submitted

July 24, 2019

First Posted

August 26, 2019

Study Start

September 13, 2019

Primary Completion

June 13, 2025

Study Completion

June 13, 2025

Last Updated

September 13, 2023

Record last verified: 2023-09

Locations

IT(2)