Back to resultsSTereotactic RadioAblation by Multimodal Imaging for VT (STRA-MI-VT) (STRA-MI-VT)
Primary Purpose
Refractory Ventricular Tachycardia
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
SBRT
Sponsored by
About this trial
This is an interventional treatment trial for Refractory Ventricular Tachycardia
Eligibility Criteria
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.
Sites / Locations
- Centro Cardiologico Monzino, IRCCSRecruiting
- Istituto Europeo di Oncologia, IRCCS
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Open Label
Arm Description
Non-randomized, open label clinical trial that intends to treat with SBRT 15 patients with refractory VT.
Outcomes
Primary Outcome Measures
SBRT safety during 12 month follow-up
Serious adverse events will be defined using CTCAE v4.0 criteria.
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
Secondary Outcome Measures
Total mortality
Health related quality of life
Health related quality of life for positive or negative changes based on score from SF-36 Questionnaire
Cardiac functional changes
Cardiac functional changes evaluated by echocardiography ejection fraction
Full Information
NCT ID
NCT04066517
First Posted
July 24, 2019
Last Updated
September 11, 2023
Sponsor
Centro Cardiologico Monzino
Collaborators
Istituto Europeo di Oncologia
1. Study Identification
Unique Protocol Identification Number
NCT04066517
Brief Title
STereotactic RadioAblation by Multimodal Imaging for VT (STRA-MI-VT)
Acronym
STRA-MI-VT
Official Title
STereotactic RadioAblation by Multimodal Imaging for VT (STRA-MI-VT)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2019 (Actual)
Primary Completion Date
June 13, 2025 (Anticipated)
Study Completion Date
June 13, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Cardiologico Monzino
Collaborators
Istituto Europeo di Oncologia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Ventricular Tachycardia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
No masking in this study.
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Open Label
Arm Type
Experimental
Arm Description
Non-randomized, open label clinical trial that intends to treat with SBRT 15 patients with refractory VT.
Intervention Type
Procedure
Intervention Name(s)
SBRT
Intervention Description
Multimodal-imaging guided SBRT for VT ablation.
Primary Outcome Measure Information:
Title
SBRT safety during 12 month follow-up
Description
Serious adverse events will be defined using CTCAE v4.0 criteria.
Time Frame
12 months
Title
SBRT efficacy based on reduction of VT episodes during 12 month follow-up
Description
There will be 6 week blanking period after therapy to allow for ablation effect
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Total mortality
Time Frame
12 months
Title
Health related quality of life
Description
Health related quality of life for positive or negative changes based on score from SF-36 Questionnaire
Time Frame
12 months
Title
Cardiac functional changes
Description
Cardiac functional changes evaluated by echocardiography ejection fraction
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Corrado Carbucicchio, MD
Phone
+39 02 58001626
Email
corrado.carbucicchio@ccfm.it
First Name & Middle Initial & Last Name or Official Title & Degree
Valentina Catto, PhD
Phone
+39 02 58002856
Email
valentina.catto@ccfm.it
Facility Information:
Facility Name
Centro Cardiologico Monzino, IRCCS
City
Milano
State/Province
MI
ZIP/Postal Code
20138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Corrado Carbucicchio, MD
Phone
+39 02 58001626
Email
corrado.carbucicchio@ccfm.it
First Name & Middle Initial & Last Name & Degree
Valentina Catto, PhD
Phone
+39 02 58002856
Email
valentina.catto@ccfm.it
First Name & Middle Initial & Last Name & Degree
Corrado Carbucicchio, MD
First Name & Middle Initial & Last Name & Degree
Daniele Andreini, MD, PhD
Facility Name
Istituto Europeo di Oncologia, IRCCS
City
Milano
State/Province
MI
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Active, not recruiting
12. IPD Sharing Statement
Citations:
PubMed Identifier
32851578
Citation
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.
Results Reference
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PubMed Identifier
34609691
Citation
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.
Results Reference
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STereotactic RadioAblation by Multimodal Imaging for VT (STRA-MI-VT)
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