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

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ClinicalTrials.gov Identifier: NCT04066517
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : August 26, 2019
Sponsor:
Collaborator:
Istituto Europeo di Oncologia
Information provided by (Responsible Party):
Corrado Carbucicchio, Centro Cardiologico Monzino

Brief Summary:
Phase Ib/II study of multimodal-imaging guided stereotactic body radiotherapy (SBRT) for ventricular tachycardia (VT) ablation.

Condition or disease Intervention/treatment Phase
Refractory Ventricular Tachycardia Procedure: SBRT Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: No masking in this study.
Primary Purpose: Treatment
Official Title: STereotactic RadioAblation by Multimodal Imaging for VT (STRA-MI-VT)
Estimated Study Start Date : September 5, 2019
Estimated Primary Completion Date : July 20, 2022
Estimated Study Completion Date : July 20, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Open Label
Non-randomized, open label clinical trial that intends to treat with SBRT 15 patients with refractory VT.
Procedure: SBRT
Multimodal-imaging guided SBRT for VT ablation.




Primary Outcome Measures :
  1. SBRT safety during 12 month follow-up [ Time Frame: 12 months ]
    Serious adverse events will be defined using CTCAE v4.0 criteria.

  2. SBRT efficacy based on reduction of VT episodes during 12 month follow-up [ Time Frame: 12 months ]
    There will be 6 week blanking period after therapy to allow for ablation effect


Secondary Outcome Measures :
  1. Total mortality [ Time Frame: 12 months ]
  2. Health related quality of life [ Time Frame: 12 months ]
    Health related quality of life for positive or negative changes based on score from SF-36 Questionnaire

  3. Cardiac functional changes [ Time Frame: 12 months ]
    Cardiac functional changes evaluated by echocardiography ejection fraction



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 ≥ 60 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04066517


Contacts
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Contact: Corrado Carbucicchio, MD +39 02 58001626 corrado.carbucicchio@ccfm.it
Contact: Valentina Catto, PhD +39 02 58002856 valentina.catto@ccfm.it

Locations
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Italy
Centro Cardiologico Monzino, IRCCS Recruiting
Milano, MI, Italy, 20138
Contact: Corrado Carbucicchio, MD    +39 02 58001626    corrado.carbucicchio@ccfm.it   
Contact: Valentina Catto, PhD    +39 02 58002856    valentina.catto@ccfm.it   
Principal Investigator: Corrado Carbucicchio, MD         
Sub-Investigator: Daniele Andreini, MD, PhD         
Istituto Europeo di Oncologia, IRCCS Active, not recruiting
Milano, MI, Italy, 20141
Sponsors and Collaborators
Centro Cardiologico Monzino
Istituto Europeo di Oncologia

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Responsible Party: Corrado Carbucicchio, Head of Ventricular Intensive Care Unit, Centro Cardiologico Monzino
ClinicalTrials.gov Identifier: NCT04066517     History of Changes
Other Study ID Numbers: R 918/19 - CCM968
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes