GANGlion Stellate Block for Treatment of Electric storRm (GANGSTER Trial)

Last updated: October 14, 2021
Sponsor: Institute for Clinical and Experimental Medicine
Overall Status: Active - Recruiting

Phase

3

Condition

Heart Disease

Chest Pain

Cardiac Disease

Treatment

N/A

Clinical Study ID

NCT05078684
A-21-25
  • Ages > 18
  • All Genders

Study Summary

This study will evaluate the acute effect of ultrasound-navigated left ganglion stellate block to suppress ventricular arrhythmia in patients with arrhythmic storm.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. arrhythmic storm <24 hours before inclusion:
  • 3 or more episodes of sustained ventricular tachycardia (VT) or ventricularfibrillation (VF) terminated by external or internal shock,
  • or incessant VT lasting >30 minutes,
  • or very frequent nonsustained or sustained VT leading to hemodynamic instabilitywith the need of escalation of the therapy
  1. clinical indication for LBGS based on the judgment of the physician, independent ofthe study

Exclusion

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

Study Design

Total Participants: 80
Study Start date:
August 21, 2021
Estimated Completion Date:
January 31, 2025

Study 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.

Connect with a study center

  • Institute for Clinical and Experimental Medicine (IKEM)

    Prague, 14059
    Czechia

    Active - Recruiting

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