GANGlion Stellate Block for Treatment of Electric storRm (GANGSTER Trial)
NCT ID: NCT05078684
Last Updated: 2021-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
80 participants
INTERVENTIONAL
2021-08-21
2025-01-31
Brief Summary
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Detailed Description
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* Included participants will be dived based on the need for mechanical ventilation and catheter ablation performed \<5 days before the study
* Subsequently, the participants will be randomized to LGSB or to a sham (placebo) procedure.
* The primary endpoint will be a reduction of the burden of clinical arrhythmia \>50% 24 hours after LGSB without escalation of antiarrhythmic therapy.
* The study will include 80 patients over 4 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Actual LGSB
The patients will receive an actual LGSB procedure:
Using ultrasound navigation and an echo-contrast needle, 8ml of bupivacain (5%) will be applied to the site of the left ganglion stellate through an anterolateral approach in the neck region.
Left ganglion stellate block
Ultrasound-guided anesthetic block of left ganglion stellate using 8ml of 5% bupivacaine.
Sham procedure
The procedure will be performed using the same instruments and anesthetic drug as the actual LGSB. However, the operator will apply only 0.5-1ml of the anesthetic drug and only subcutaneously to the site where an actual LGSB would be performed.
Sham left ganglion stellate block
Subcutaneous application of 0.5-1ml of 5% bupivacaine to the site of expected LGSB
Interventions
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Left ganglion stellate block
Ultrasound-guided anesthetic block of left ganglion stellate using 8ml of 5% bupivacaine.
Sham left ganglion stellate block
Subcutaneous application of 0.5-1ml of 5% bupivacaine to the site of expected LGSB
Eligibility Criteria
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Inclusion Criteria
* 3 or more episodes of sustained ventricular tachycardia (VT) or ventricular fibrillation (VF) terminated by external or internal shock,
* or incessant VT lasting \>30 minutes,
* or very frequent nonsustained or sustained VT leading to hemodynamic instability with the need of escalation of the therapy
2. clinical indication for LBGS based on the judgment of the physician, independent of the study
Exclusion Criteria
2. prior LBGS performed \<7 days before the study
3. known reversible provoking trigger of the arrhythmias
4. ventricular arrhythmias triggered by premature ectopic beats during bradycardia
5. hemodynamically tolerated idiopathic VT in patients without structural heart disease
18 Years
ALL
No
Sponsors
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Institute for Clinical and Experimental Medicine
OTHER_GOV
Responsible Party
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Marek Sramko, MD, PhD
Head of the Department of Acute Cardiology
Locations
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Institute for Clinical and Experimental Medicine (IKEM)
Prague, , Czechia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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A-21-25
Identifier Type: -
Identifier Source: org_study_id