STereotactic RadioAblation by Multimodal Imaging for VT (STRA-MI-VT) (STRA-MI-VT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04066517|
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : May 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Refractory Ventricular Tachycardia||Procedure: SBRT||Phase 1 Phase 2|
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.
|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.|
|Official Title:||STereotactic RadioAblation by Multimodal Imaging for VT (STRA-MI-VT)|
|Actual Study Start Date :||September 13, 2019|
|Estimated Primary Completion Date :||September 13, 2022|
|Estimated Study Completion Date :||September 13, 2024|
Experimental: Open Label
Non-randomized, open label clinical trial that intends to treat with SBRT 15 patients with refractory VT.
Multimodal-imaging guided SBRT for VT ablation.
- SBRT safety during 12 month follow-up [ Time Frame: 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 [ Time Frame: 12 months ]There will be 6 week blanking period after therapy to allow for ablation effect
- Total mortality [ Time Frame: 12 months ]
- 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
- Cardiac functional changes [ Time Frame: 12 months ]Cardiac functional changes evaluated by echocardiography ejection fraction
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
|Contact: Corrado Carbucicchio, MD||+39 02 email@example.com|
|Contact: Valentina Catto, PhD||+39 02 firstname.lastname@example.org|
|Centro Cardiologico Monzino, IRCCS||Recruiting|
|Milano, MI, Italy, 20138|
|Contact: Corrado Carbucicchio, MD +39 02 58001626 email@example.com|
|Contact: Valentina Catto, PhD +39 02 58002856 firstname.lastname@example.org|
|Principal Investigator: Corrado Carbucicchio, MD|
|Sub-Investigator: Daniele Andreini, MD, PhD|
|Istituto Europeo di Oncologia, IRCCS||Active, not recruiting|
|Milano, MI, Italy, 20141|