Back to resultsPercutaneous Inferior Cervical Sympathetic Block for Treatment of Refractory Ventricular Tachycardia
Primary Purpose
Ventricular Tachycardia
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Percutaneous inferior cervical sympathetic block
Sponsored by
About this trial
This is an interventional treatment trial for Ventricular Tachycardia
Eligibility Criteria
Inclusion Criteria:
- Appropriate ICD shock for ventricular tachycardia (VT) after at least one catheter ablation of VT procedure, OR appropriate ICD shock for VT but not a candidate for catheter ablation of VT (i.e. patients with presence polymorphic VT or ventricular fibrillation, LV thrombus, VT arising from an inaccessible myocardial location).
- Presence of structural heart disease as defined as EF ≤ 50%, presence of ventricular scar as detected by imaging modalities or electroanatomic mapping, hypertrophic cardiomyopathy, cardiac sarcoidosis, or arrhythmogenic right ventricular cardiomyopathy.
- Patient is taking at least one anti-arrhythmic drug or has documented intolerance or toxicity to at least one anti-arrhythmic drug.
- Age greater than 18 years old.
- Able and willing to comply with all pre- and follow-up testing and requirements.
- Provision of signed informed consent and stated willingness to comply with all study procedures for duration of the study.
Exclusion Criteria:
- Active ongoing cardiac ischemia as assessed by: EKG, cardiac enzymes, symptoms, coronary angiography with evidence of significant epicardial coronary stenosis (>70%), or stress testing. (Note: positive troponin assay due to ICD shocks is not an exclusion criterion).
- Any medical or non-medical condition likely to prevent completion of trial.
- Contraindication to cardiac sympathetic denervation (i.e. single-lung ventilation, severe pulmonary disease, or severe pulmonary hypertension) or previous cardiac sympathetic denervation procedure.
- Left ventricular assist device or status post orthotopic heart transplantation
- Severe thrombocytopenia (platelets < 50,000) or coagulopathy (INR > 2.0) that is not due to medications or a reversible cause.
- Women who are pregnant (as evidenced by pregnancy test if pre-menopausal).
- Unable or unwilling to comply with protocol requirements.
- NYHA class IV heart failure symptoms.
- Known channelopathy such as long QT syndrome and catecholaminergic polymorphic VT.
- Presentation with slow VT (VT rate < 150 bpm).
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Percutaneous inferior cervical sympathetic block
Arm Description
The procedure will be performed while the patient was awake and under fluoroscopic guidance. A total of 3 ml of 1% lidocaine will be infiltrated to anesthetize the skin and subcutaneous tissues down to the left common carotid artery. A 22 gauge × 3.5 inch BD™ Quincke spinal needle will be introduced at the level of the body of the sixth cervical vertebra, medial to the left common carotid artery. The needle will be advanced until it reached the junction between the body and transverse process of the sixth cervical vertebra. Contrast injection will be used to demonstrate the position of the needle anterior to the paravertebral muscles, with spread along the axis of the interfascial compartment (Figure 1). A total of 20 ml of 0.25% bupivacaine (Marcaine, Hospira, Lake Forest, IL) will be injected over 10 min through the needle. The effectiveness of sympathetic blockade will be confirmed by postprocedure development of ptosis and miosis in the left eye.
Outcomes
Primary Outcome Measures
Freedom from implantable cardioverter-defibrillator shock
Zero number of required cardioverter-defibrillator shocks in the patient's medical records
Secondary Outcome Measures
Full Information
NCT ID
NCT04770051
First Posted
January 19, 2021
Last Updated
August 2, 2023
Sponsor
University of Missouri-Columbia
1. Study Identification
Unique Protocol Identification Number
NCT04770051
Brief Title
Percutaneous Inferior Cervical Sympathetic Block for Treatment of Refractory Ventricular Tachycardia
Official Title
Percutaneous Inferior Cervical Sympathetic Block for Treatment of Refractory Ventricular Tachycardia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of resources to conduct study.
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this research study is to examine the effect of percutaneous inferior cervical sympathetic block on life threatening abnormal heart rhythms called ventricular tachycardia or ventricular fibrillation that can lead to sudden cardiac death.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Percutaneous inferior cervical sympathetic block
Arm Type
Experimental
Arm Description
The procedure will be performed while the patient was awake and under fluoroscopic guidance. A total of 3 ml of 1% lidocaine will be infiltrated to anesthetize the skin and subcutaneous tissues down to the left common carotid artery. A 22 gauge × 3.5 inch BD™ Quincke spinal needle will be introduced at the level of the body of the sixth cervical vertebra, medial to the left common carotid artery. The needle will be advanced until it reached the junction between the body and transverse process of the sixth cervical vertebra. Contrast injection will be used to demonstrate the position of the needle anterior to the paravertebral muscles, with spread along the axis of the interfascial compartment (Figure 1). A total of 20 ml of 0.25% bupivacaine (Marcaine, Hospira, Lake Forest, IL) will be injected over 10 min through the needle. The effectiveness of sympathetic blockade will be confirmed by postprocedure development of ptosis and miosis in the left eye.
Intervention Type
Procedure
Intervention Name(s)
Percutaneous inferior cervical sympathetic block
Intervention Description
The procedure will be performed while the patient was awake and under fluoroscopic guidance. A total of 3 ml of 1% lidocaine will be infiltrated to anesthetize the skin and subcutaneous tissues down to the left common carotid artery. A 22 gauge × 3.5 inch BD™ Quincke spinal needle will be introduced at the level of the body of the sixth cervical vertebra, medial to the left common carotid artery. The needle will be advanced until it reached the junction between the body and transverse process of the sixth cervical vertebra. Contrast injection will be used to demonstrate the position of the needle anterior to the paravertebral muscles, with spread along the axis of the interfascial compartment (Figure 1). A total of 20 ml of 0.25% bupivacaine (Marcaine, Hospira, Lake Forest, IL) will be injected over 10 min through the needle. The effectiveness of sympathetic blockade will be confirmed by postprocedure development of ptosis and miosis in the left eye.
Primary Outcome Measure Information:
Title
Freedom from implantable cardioverter-defibrillator shock
Description
Zero number of required cardioverter-defibrillator shocks in the patient's medical records
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Appropriate ICD shock for ventricular tachycardia (VT) after at least one catheter ablation of VT procedure, OR appropriate ICD shock for VT but not a candidate for catheter ablation of VT (i.e. patients with presence polymorphic VT or ventricular fibrillation, LV thrombus, VT arising from an inaccessible myocardial location).
Presence of structural heart disease as defined as EF ≤ 50%, presence of ventricular scar as detected by imaging modalities or electroanatomic mapping, hypertrophic cardiomyopathy, cardiac sarcoidosis, or arrhythmogenic right ventricular cardiomyopathy.
Patient is taking at least one anti-arrhythmic drug or has documented intolerance or toxicity to at least one anti-arrhythmic drug.
Age greater than 18 years old.
Able and willing to comply with all pre- and follow-up testing and requirements.
Provision of signed informed consent and stated willingness to comply with all study procedures for duration of the study.
Exclusion Criteria:
Active ongoing cardiac ischemia as assessed by: EKG, cardiac enzymes, symptoms, coronary angiography with evidence of significant epicardial coronary stenosis (>70%), or stress testing. (Note: positive troponin assay due to ICD shocks is not an exclusion criterion).
Any medical or non-medical condition likely to prevent completion of trial.
Contraindication to cardiac sympathetic denervation (i.e. single-lung ventilation, severe pulmonary disease, or severe pulmonary hypertension) or previous cardiac sympathetic denervation procedure.
Left ventricular assist device or status post orthotopic heart transplantation
Severe thrombocytopenia (platelets < 50,000) or coagulopathy (INR > 2.0) that is not due to medications or a reversible cause.
Women who are pregnant (as evidenced by pregnancy test if pre-menopausal).
Unable or unwilling to comply with protocol requirements.
NYHA class IV heart failure symptoms.
Known channelopathy such as long QT syndrome and catecholaminergic polymorphic VT.
Presentation with slow VT (VT rate < 150 bpm).
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Percutaneous Inferior Cervical Sympathetic Block for Treatment of Refractory Ventricular Tachycardia
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