Arrhythmic Storm, Block, Ventricular Arrythmia, Ventricular Fibrillation, Ventricular Tachycardia
Conditions
Brief summary
This study will evaluate the acute effect of ultrasound-navigated left ganglion stellate block to suppress ventricular arrhythmia in patients with arrhythmic storm.
Detailed description
* The study will include patients with drug-refractory arrhythmic storm indicated for left ganglion stellate block (LGSB) before or after catheter ablation. * 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.
Interventions
PROCEDURELeft ganglion stellate block
Ultrasound-guided anesthetic block of left ganglion stellate using 8ml of 5% bupivacaine.
PROCEDURESham left ganglion stellate block
Subcutaneous application of 0.5-1ml of 5% bupivacaine to the site of expected LGSB
Sponsors
Institute for Clinical and Experimental Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Patients, attending staff, and outcome assessors will not know whether the patient received the actual LGSB or a sham (placebo) procedure. The sham procedure will consist of subcutaneous application of a small amount (1ml) of the local anesthetic drug to the region of expected LGSB procedure.
Intervention model description
Randomization 1:1 for active treatment vs. sham procedure
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. arrhythmic storm \<24 hours before inclusion: * 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
1. known allergy to bupivacaine 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the number of episodes of sustained VT/VF | 2-24 hours after LGSB. The first 2 hours after the LGSB will not be considered in the evaluation (i.e., blanking period) | Change by \>50% of the number of episodes of sustained ventricular tachycardia/fibrillation compared to 24 hours before LGSB, without escalation of antiarrhythmic therapy during 24 hours after LGSB (deep sedation requiring mechanical ventilation, addition of another antiarrhythmic drug, implantation of mechanical circulatory support, unplanned emergent catheter ablation) |
| Change in arrhythmia burden quantified by Holter ECG | 2-24 hours after LGSB. The first 2 hours after the LGSB will not be considered in the evaluation (i.e., blanking period) | Change of the percent of QRS complexes with ventricular tachycardia by \>50% on Holter ECG, as compared to 24 hours before LGSB, without escalation of antiarrhythmic therapy during 24 hours after LGSB (deep sedation requiring mechanical ventilation, addition of another antiarrhythmic drug, implantation of mechanical circulatory support, unplanned emergent catheter ablation). |
Countries
Czechia
Contacts
Primary ContactMarek Sramko, MD, PhD
Outcome results
None listed