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Neuromodulator
Nerve Block for Heart Rhythm Problems
Phase < 1
Recruiting
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Planned catheter based VT ablation
Age at least 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes following stellate ganglion block
Awards & highlights
Study Summary
This trial looks at whether a nerve block can help treat heart rhythm problems.
Who is the study for?
This trial is for adults at least 18 years old who are scheduled to have a catheter-based procedure to correct rapid, irregular heartbeats known as ventricular tachycardia. Pregnant individuals, those with conditions that make the stellate ganglion block or VT ablation unsafe, and people allergic to certain local anesthetics cannot participate.Check my eligibility
What is being tested?
The study is examining how a nerve-blocking injection called Stellate Ganglion Block (SGB) affects the electrical activity of the heart in patients with ventricular tachycardia. It's a forward-looking study tracking participants over time.See study design
What are the potential side effects?
Potential side effects of SGB may include discomfort at the injection site, changes in blood pressure, headache, drooping eyelid on one side (Horner's syndrome), difficulty swallowing, and voice changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for a procedure to treat irregular heartbeats using catheters.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 minutes following stellate ganglion block
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes following stellate ganglion block
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ventricular Effective Refractory Period
Secondary outcome measures
Neuropeptides
Ventricular Arrhythmia Inducibility
Side effects data
From 2022 Phase 1 & 2 trial • 20 Patients • NCT05445921100%
Horner syndrome
45%
Hoarseness
35%
Globus
25%
Brief lightheadedness
20%
Mild shortness of breath
20%
Numbness of the face
15%
Nasal congestion
15%
Pain at the injection site
15%
Fatigue
5%
Weakness of the arm
5%
Tightness of the shoulder
5%
Tightness of the back
5%
Cough
5%
Chest heaviness
5%
Bruising of the injection site
5%
Headache
5%
Palpitations
5%
Arm heaviness
5%
Weakness of the neck/back
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stellate Ganglion Block
Trial Design
1Treatment groups
Experimental Treatment
Group I: Stellate ganglion blockExperimental Treatment1 Intervention
All subjects will undergo stellate ganglion block during their VT ablation procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stellate Ganglion Block
2020
Completed Phase 2
~200
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
1,994 Previous Clinical Trials
42,879,236 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for a procedure to treat irregular heartbeats using catheters.I cannot undergo SGB or VT ablation due to health reasons.You had unstable blood pressure or heart rate during a medical procedure before the study.I am 18 years old or older.You are allergic to a certain type of local anesthetic called amide.
Research Study Groups:
This trial has the following groups:- Group 1: Stellate ganglion block
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment enrolling participants at present?
"Clinicaltrials.gov demonstrates that this clinical trial, initially posted on September 1st 2022, is actively seeking participants. The latest update was made on the 28th of September."
Answered by AI
How many participants is the clinical trial recruiting at this time?
"Affirmative. Clinicaltrials.gov confirms that this clinical study, which was first posted on September 1st 2022, is currently searching for qualified participants. Specifically, the trial requires 20 people to be enrolled from a single medical centre."
Answered by AI
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