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Device
Nerve Stimulation Therapy for Rapid Heartbeat after Heart Attack (EARLY-VAGUS Trial)
N/A
Waitlist Available
Research Sponsored by Hippocration General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ST-elevation myocardial infarction which is treated with a primary percutaneous coronary intervention
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 7 and 40 days follow-up
Awards & highlights
EARLY-VAGUS Trial Summary
This trial will test if a nerve stimulation therapy can reduce premature heart contractions after experiencing a heart attack.
Who is the study for?
This trial is for men and women over 18 who've had a recent heart attack treated with an artery-opening procedure. They must agree to the study rules and follow-up schedule. It's not for those with recent heart procedures, on certain heart drugs, thyroid or severe kidney issues, very short life expectancy, listed for a heart transplant, unstable angina despite treatment, worst class of heart failure, in cardiogenic shock, pregnant women or those with specific genetic heart conditions.Check my eligibility
What is being tested?
The trial tests if a non-invasive device called Parasym can prevent rapid heartbeat after a major heart attack by stimulating the vagus nerve through the skin. Participants are randomly assigned to use either an active device that delivers current below discomfort level or a sham (fake) device without current. The study will last about 12 months across two centers in Greece.See study design
What are the potential side effects?
Since this involves non-invasive stimulation at levels below discomfort thresholds using the Parasym device, side effects may be minimal but could include local irritation where the device contacts skin and potential temporary changes in heartbeat patterns.
EARLY-VAGUS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had a severe heart attack treated with a procedure to open my heart's arteries.
EARLY-VAGUS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1, 7 and 40 days follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 7 and 40 days follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change of Ventricular tachycardia burden
Secondary outcome measures
Change of Deceleration Capacity (DC)
Change of Echocardiographic strain
Change of Heart Rate Turbulence
+7 moreEARLY-VAGUS Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active Transcutaneous Vagal Nerve StimulationActive Control1 Intervention
Group II: Sham Transcutaneous Vagal Nerve StimulationPlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
Hippocration General HospitalLead Sponsor
26 Previous Clinical Trials
4,006 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a specific type of heart block and do not have a pacemaker.You have a pre-existing device called an implantable cardioverter-defibrillator (ICD).I am not pregnant.I have a diagnosed heart rhythm disorder.I have experienced a severe failure of my heart to pump blood.You have a slow heartbeat or a problem with your heart's natural pacemaker, and you don't have a pacemaker implanted.I am 18 years old or older.I have severe heart failure that doesn't improve with medication.I have had fainting spells more than once.I was born with a complex heart condition.I need an ICD because of serious heart rhythm problems after a heart attack.I have ongoing chest pain despite having heart surgery and taking medication.I had an ablation less than 3 months ago.I am currently taking amiodarone.I have thyroid problems and am on kidney dialysis.You are expected to live for less than 12 months.I had a severe heart attack treated with a procedure to open my heart's arteries.
Research Study Groups:
This trial has the following groups:- Group 1: Sham Transcutaneous Vagal Nerve Stimulation
- Group 2: Active Transcutaneous Vagal Nerve Stimulation
Awards:
This trial has 0 awards, including: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.
Are there available slots in this research initiative for participants?
"Based on the information present on clinicaltrials.gov, this trial is not recruiting patients currently. Initially posted to the website in June of 2023 and most recently updated in February of 2023, it appears that this study has stopped its search for participants; however, there are 458 other trials seeking enrollees presently."
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