Ganglion Stellate Block for Treatment of Electric Storm - a Randomized Study
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Institute for Clinical and Experimental Medicine
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Change in the number of episodes of sustained VT/VF
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, 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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •clinical indication for LBGS based on the judgment of the physician, independent of the study
Exclusion Criteria
- •known allergy to bupivacaine
- •prior LBGS performed \<7 days before the study
- •known reversible provoking trigger of the arrhythmias
- •ventricular arrhythmias triggered by premature ectopic beats during bradycardia
- •hemodynamically tolerated idiopathic VT in patients without structural heart disease
Outcomes
Primary Outcomes
Change in the number of episodes of sustained VT/VF
Time Frame: 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
Time Frame: 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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Marek Sramko, MD, PhD
Head of the Department of Acute Cardiology
Institute for Clinical and Experimental Medicine