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New heart procedure could replace pacemakers for fainting patients

NCT ID NCT06166277

Disease control Sponsor: Rush University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study is tracking 300 people under age 60 who faint frequently due to a condition called vasovagal syncope. Participants will receive either a nerve ablation procedure (which targets heart nerves) or a permanent pacemaker. The goal is to see which treatment better prevents fainting episodes and improves quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
radiofrequency catheter ablation of ganglionated plexi or permanent pacemaker implantation
What this could lead to
If successful, this could show that a nerve ablation procedure is a safe and effective alternative to a pacemaker for preventing fainting spells.
What could go wrong
This is an observational registry, not a controlled trial, so results may be less definitive. The ablation procedure carries risks like bleeding, infection, or heart rhythm problems.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with vasovagal syncope or symptomatic bradyarrhythmia

Ages

18 to 60 years

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * symptomatic vasovagal syncope or symptomatic bradyarrhythmia refractory to behavioral and medical measures * age \< 60 years Exclusion Criteria: * age \> 60 years * intra-/infra-Hisian AV block * intrinsic sinus node disease * history of supraventricular tachycardia * history of ventricular tachycardia * presence of structural heart disease related * prior history of catheter ablation * presence of inheritable arrhythmic conditions * orthostatic hypotension on HUTT test * abnormal thyroid function levels * Proven indication for permanent pacemaker implantation

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Conditions

The condition(s) this trial relates to.

atrial standstill atrioventricular block Mobitz type I atrioventricular block syncope, familial vasovagal Syncope, Vasovagal

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Av block-2ND degree-type 1 Sinus pause Vasovagal syncope

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Rush University Medical Centert

    RECRUITING

    Chicago, Illinois, 60657, United States

More trials for these conditions

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