Non-invasive Ablation of Ventricular Tachycardia
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|ClinicalTrials.gov Identifier: NCT03601832|
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : January 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ventricular Tachycardia||Procedure: 4-D navigated stereotactic radiosurgical ablation||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All patients enroled in the study are allocated to one group with 4-D navigated stereotactic radiosurgical ablation.|
|Masking:||None (Open Label)|
|Masking Description:||No masking in this study.|
|Official Title:||Phase I/II Study of 4-D Navigated Non-invasive Radiosurgical Ablation of Ventricular Tachycardia|
|Actual Study Start Date :||August 1, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||January 31, 2020|
Experimental: 4-D navigated stereotactic radiosurgical ablation
The patients enroled to this arm of the study will undergo 4-D navigated stereotactic radiosurgical ablation.
Procedure: 4-D navigated stereotactic radiosurgical ablation
4-D Navigated Non-invasive radiosurgical ablation of ventricular tachycardia in patients with sustained monomorphic ventricular tachycardia/tachycardias after myocardial infarction.
- Composite of death [ Time Frame: 90 days ]Composite of death occurring at any time after treatment or arrhythmic storm (three or more documented episodes of VT within 24 hours) or appropriate ICD therapy (both shock and pacing) after a 90-day treatment period. 90-day treatment period was imposed to exclude nonfatal outcomes that might occur during acute radiation reaction. Moreover, functional radiosurgery has 90% success rate after 3 months.
- Acute radiation-induced events [ Time Frame: 18 months ]Acute radiation-induced events (within 3 months after treatment) according to CTCAE 4.0. Major concern will be on radiation myocarditis, pericarditis and pneumonitis/fibrosis. Needs of antiemetic drugs will be recorded.
- Late radiation-induced effects [ Time Frame: 18 months ]Late radiation-induced effects (after 3 months after treatment) according to CTCAE 4.0. Major concern will be on radiation myocarditis, pericarditis and pneumonitis/fibrosis. Needs of antiemetic drugs will be recorded.
- Time to death at any time [ Time Frame: 18 months ]
- Time to arrhythmic storm [ Time Frame: 90 days ]Time to arrhythmic storm (three or more documented episodes of VT within 24 hours) at any time and after 90-day treatment period.
- Time to appropriate ICD shock [ Time Frame: 90 days ]Time to appropriate ICD shock at any time and after 90-day treatment period.
- Time to appropriate antitachycardial pacing by ICD [ Time Frame: 90 days ]Time to appropriate antitachycardial pacing by ICD at any time and after 90-day treatment period.
- Hospitalization due to VT [ Time Frame: 18 months ]
- Hospitalization due to chronic heart failure [ Time Frame: 18 months ]
- Quality of life measured with EQ-5D questionnaire [ Time Frame: 18 months ]Quality of life measurement using a standardised tool named EQ-5D. EQ-5D is a standardised instrument in the form of a questionnaire developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D instrument consists of a descriptive system and the EuroQol-visual analogue scales (EQ VAS). The quality of life is measured in 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The higher the score achieved, the higher the quality of life of the patient.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03601832
|Contact: Petr Vávra, Ass.Prof.,MD,Ph.D.||0042059737 ext firstname.lastname@example.org|
|Contact: Jiří Hynčica||0042059737 ext email@example.com|
|Hospital Nový Jičín, Nuclear Medicine - PET/CT||Recruiting|
|Nový Jičín, Moravian-Silesian Region, Czechia, 741 01|
|Principal Investigator: Andrea Bronczková, MD,MBA|
|University Hospital Ostrava||Recruiting|
|Ostrava, Moravian-Silesian Region, Czechia, 708 52|
|Contact: Petr Vávra, Ass.Prof.,MD,Ph.D. 0042059737 ext 2544 firstname.lastname@example.org|
|Contact: Jiří Hynčica 0042059737 ext 2587 email@example.com|
|Principal Investigator: Jakub Cvek, Ing.,MD,Ph.D.|
|Třinec, Moravian-Silesian Region, Czechia, 739 61|
|Contact: Radek Neuwirth, MD,MBA 00420558304 ext 140 firstname.lastname@example.org|
|Sub-Investigator: Radek Neuwirth, MD,MBA|
|Sub-Investigator: Otakar Jiravský, MD|
|Principal Investigator:||Jakub Cvek, Ing.,MD,Ph.D.||University Hospital Ostrava|