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New registry to reveal if heart ablation helps POTS and IST patients

NCT ID NCT05107635

Knowledge-focused Sponsor: AtriCure, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This registry will follow 500 people with inappropriate sinus tachycardia (IST) or postural orthostatic tachycardia syndrome (POTS) who have had or will have a heart ablation procedure using AtriCure devices. The goal is to collect real-world data on how safe and effective the procedure is. Participants are enrolled at multiple centers in the US and abroad.

What this could mean

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

Active substance
Cardiac ablation procedure using AtriCure devices
What this could lead to
If successful, this registry could provide clearer evidence on whether heart ablation is a safe and effective option for people with IST or POTS.
What could go wrong
This is an observational registry, not a controlled trial, so it cannot prove cause and effect. Results may be influenced by differences in patient care or device use across sites.
Why investors are watching

AtriCure is running a registry that tracks real-world outcomes of its ablation devices in patients with inappropriate sinus tachycardia and postural orthostatic tachycardia syndrome. For a small company, this registry could provide evidence that its devices work in these conditions, which may support broader use and reimbursement. The result matters because it tests whether the company's existing technology can expand into new patient groups.

If it works: A positive result could show that AtriCure's devices help patients with these heart rhythm conditions, which might encourage more doctors to use them and strengthen the company's position in the market. This could lead to wider adoption of the devices beyond current uses.

If it fails: If the registry shows poor outcomes or safety issues, it could hurt the company's reputation and limit future sales. Registries often produce mixed or inconclusive results, and there is no guarantee the data will support the devices.

AI-written from the trial record. Speculative, and not investment advice.

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 500 people

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

Started

Mar 2022

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

The IST registry eligibility is open to sites and physicians performing the described treatments for patients diagnosed with IST and POTS. Subjects must have been scheduled to undergo or have undergone the described treatments for IST or POTS by their physicians. Registry participating sites will enroll patients that meet all inclusion criteria and no exclusion criteria without preselection or bias.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: 1. Subject is scheduled to undergo or has undergone a procedure to treat IST or POTS using one or more AtriCure devices. 2. Subject is willing to provide written informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this Registry) or authorization per institution and geographical requirements Exclusion Criteria: 1. Subject is enrolled in a concurrent study that may impact treatment outcome of IST or POTS. 2. Subject with exclusion criteria required by FDA or local governance

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Conditions

The condition(s) this trial relates to.

postural orthostatic tachycardia syndrome

As listed by the trial registrant

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

Inappropriate sinus tachycardia Postural tachycardia syndrome

How to take part

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

  1. The places running it

    15 sites in 4 countries. 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

  • Central Clinic Hospital

    RECRUITING

    Warsaw, 02-507, Poland

  • HCA Osceola Regional Medical Center

    RECRUITING

    Kissimmee, Florida, 34741, United States

  • IRCCS Ospedale San Raffaele

    RECRUITING

    San Raffaele, Italy

  • Intermountain Medical Center

    RECRUITING

    Murray, Utah, 84107, United States

  • Kansas City Cardiac Arrhythmia Research

    RECRUITING

    Kansas City, Kansas, 64132, United States

  • Loma Linda University Health

    RECRUITING

    Loma Linda, California, 92354, United States

  • MedStar Health Research Institute

    RECRUITING

    Hyattsville, Maryland, 20782, United States

  • Sarasota Memorial Hospital

    RECRUITING

    Sarasota, Florida, 34239, United States

  • Sequoia Hospital

    RECRUITING

    Redwood City, California, 94062, United States

  • Stanford University

    RECRUITING

    Palo Alto, California, 94305, United States

  • Swedish Health Services

    RECRUITING

    Seattle, Washington, 98122, United States

  • Texas Cardiac Arrhythmia Research Foundation

    RECRUITING

    Austin, Texas, 78705, United States

  • The Carl & Edyth Lindner Center for Research & Education at The Christ Hospital

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • Universitair Ziekenhuis Brussels

    RECRUITING

    Brussels, Belgium

  • University of Florida

    RECRUITING

    Gainesville, Florida, 32608, United States

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