Nerve Stimulation Therapy for Rapid Heartbeat after Heart Attack
(EARLY-VAGUS Trial)

Recruiting in Palo Alto (17 mi)

+3 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Hippocration General Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests if using a device that sends gentle electrical pulses to a nerve can help patients who had a heart attack by reducing extra heartbeats.

Research Team

Eligibility Criteria

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.

Inclusion Criteria

Signed written informed consent by the patient for participation in the study and agreement to comply with the medication and the follow-up schedule

I am 18 years old or older.

I had a severe heart attack treated with a procedure to open my heart's arteries.

Exclusion 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.

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Treatment Details

Interventions

Parasym device (active, current (mA) < discomfort threshold) (Device)
Parasym device (sham, current (mA) = 0) (Device)

Trial OverviewThe 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.

Participant Groups

2Treatment groups

Active Control

Placebo Group

Group I: Active Transcutaneous Vagal Nerve StimulationActive Control1 Intervention

Group II: Sham Transcutaneous Vagal Nerve StimulationPlacebo Group1 Intervention