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New heart procedure aims to tame racing heartbeat without drugs

NCT ID NCT05280093

Symptom relief 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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a hybrid surgical ablation procedure for people with inappropriate sinus tachycardia (IST), a condition where the heart beats too fast without a clear cause. The procedure uses a device to carefully target heart tissue while sparing the sinus node. Researchers want to see if it safely reduces heart rate and improves symptoms like breathlessness and fatigue in 142 patients who haven't responded to medications.

What this could mean

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

Active substance
Hybrid sinus node sparing ablation procedure using the AtriCure ISOLATOR Synergy Surgical Ablation System
What this could lead to
If successful, this could offer a new treatment option for people with inappropriate sinus tachycardia who don't get relief from medications.
What could go wrong
This is an early-stage study with no control group, so results may not be definitive. The procedure is invasive and carries risks like any heart surgery.
Why investors are watching

AtriCure is testing a hybrid ablation procedure for inappropriate sinus tachycardia, a condition with few treatment options. A successful readout would give the small company a new therapy to offer patients who do not respond to drugs.

If it works: A positive result could establish AtriCure as a provider of a new treatment for a condition with limited options. That could broaden its product use and strengthen its position in the cardiac ablation market.

If it fails: The trial could fail to show the procedure is safe or effective, or the company could face delays in completing the study. Trials often fail, and a negative outcome would leave AtriCure without a new approved therapy for this condition.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 142 people

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

Started

May 2022

Expected to finish

Feb 2028

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.

Ages

18 to 75 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. Age ≥ 18 years and ≤ 75 years at time of enrollment consent 2. Subject has a diagnosis of IST 3. Documentation of refractoriness (intolerance or failure) of a drug (e.g., rate control drugs such as beta-blockers/calcium channel blockers, ivabradine), and/or AADs 4. Subject is willing and able to provide written informed consent Exclusion Criteria: 1. Subjects on whom cardiac surgery or single lung ventilation cannot be performed 2. Subjects with indication for or existing ICDs/Pacemakers 3. Presence of channelopathies 4. Previous cardio-thoracic surgery 5. Left Ventricular Ejection Fraction (LVEF) \< 50% 6. Body Mass Index (BMI) ≥ 35 7. Presence of supraventricular or ventricular tachycardia 8. Presence of Postural Orthostatic Sinus Tachycardia (POTS) 9. Presence of congenital heart disease 10. History suggestive of secondary cause of tachycardia such as pheochromocytoma, anemia, thyrotoxicosis, chronic fever of unknown origin, COPD, long-term bronchodilators use, severe asthma or carcinoid syndrome 11. Subjects who have had a previous catheter ablation in the right atrium for IST or other disorders 12. Life expectancy \< 24 months 13. Pregnant or planning to become pregnant during trial 14. Subjects with substance abuse 15. Subjects with previous weight loss surgery 16. Subject is unwilling and/or unable to return for scheduled follow-up visits 17. Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a trial that may interfere with trial results 18. Not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative) and; 19. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results

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As listed by the trial registrant

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

Inappropriate sinus tachycardia

Contacts and locations

Locations

  • Amsterdam University Medical Center

    Amsterdam, Netherlands

  • Baptist Health

    Miami, Florida, 33143, United States

  • Central Clinic Hospital

    Warsaw, Poland

  • Intermountain Healthcare

    Salt Lake City, Utah, 84111, United States

  • Kansas City Cardiac Arrhythmia Research LLC

    Overland Park, Kansas, 66211, United States

  • Loma Linda University Health

    Loma Linda, California, 92354, United States

  • Maastricht University Medical Center

    Maastricht, Netherlands

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Medstar Washington Hospital Center

    Washington D.C., District of Columbia, 20010, United States

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404, United States

  • Northern General Hospital

    Sheffield, S5 7AU, United Kingdom

  • Saint Alphonsus Regional Medical Center

    Boise, Idaho, 83706, United States

  • Saint Vincent's Medical Center

    Bridgeport, Connecticut, 06606, United States

  • San Raffaele Hospital

    Milan, Italy

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239, United States

  • Sequoia Hospital

    Redwood City, California, 94062, United States

  • St. Bernard

    Jonesboro, Arkansas, 72401, United States

  • St. Joseph's Hospital / Baycare Health System

    Tampa, Florida, 33607, United States

  • Stanford University

    Redwood City, California, 94063, United States

  • Swedish Medical Center

    Seattle, Washington, 98122, United States

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas, 78705, United States

  • The Christ Hospital

    Cincinnati, Ohio, 45219, United States

  • TriHealth, Inc.

    Cincinnati, Ohio, 45202, United States

  • UZ Brussels

    Brussels, Belgium

  • University of Florida

    Gainesville, Florida, 32610, United States

  • Virginia Commonwealth University

    Richmond, Virginia, 23219, United States

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157, United States

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