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New study examines real-world use of heart ablation device for AFib patients

NCT ID NCT07092774

Disease control Sponsor: Heart Rhythm Clinical and Research Solutions, LLC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tracks 344 adults with paroxysmal atrial fibrillation (a type of irregular heartbeat) who are having their first catheter ablation procedure using a specific device. The goal is to see how well the procedure works and how safe it is in everyday medical practice. Researchers will monitor for any return of the heart rhythm problem and for any complications related to the procedure.

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

344 people

The number who actually took part.

Started

Apr 2024

Expected to finish

Dec 2025

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

The sub-study population will consist of Class I/III AAD naïve PAF patients who underwent ablation procedure using the THERMOCOOL STSF Catheter as their first rhythm control therapy. The study will include consecutive, eligible patients from the REAL AF registry, starting from October 2021, who meet the sub-study eligibility criteria until 344 eligible subjects are identified. Eligible patients from all participating centers in the REAL AF registry will be included, except for sites with standard-of-care rhythm monitoring less than 48 hours, and those that do not perform 6-12 months follow-up as standard-of-care.

Ages

18 years and older

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: * Diagnosed with symptomatic PAF * First time ablation * Ablation performed with the Thermocool STSF catheter * Age 18 or over at the time of the index ablation procedure Exclusion Criteria: * Received Class I or III antiarrhythmic drug prior to the index ablation. * Did not previously consent for their anonymized data to be used for research purposes. * Rhythm monitoring less than 48 hours.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation paroxysmal atrial fibrillation

As listed by the trial registrant

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

Paroxysmal atrial fibrillation (PAF)

Contacts and locations

Locations

  • Allegheny Health Network

    Pittsburgh, Pennsylvania, 15222, United States

  • Arrhythmia Institute at Grandview

    Birmingham, Alabama, 35243, United States

  • Ascension St. Vincent's

    Jacksonville, Florida, 32204, United States

  • Ascension St. Vincent's Hospital

    Indianapolis, Indiana, 46260, United States

  • Centra Health, Inc. (dba Stroobants Cardiovascular Center)

    Lynchburg, Virginia, 24501, United States

  • Community Memorial Hospital

    Ventura, California, 93303, United States

  • Michigan Heart

    Ypsilanti, Michigan, 48197, United States

  • Mount Carmel Columbus Cardiology Consultants

    Columbus, Ohio, 43213, United States

  • Northshore University Health System

    Evanston, Illinois, 60201, United States

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239, United States

  • University of Pennsylvania, Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania, 19104, United States

  • Upstate Cardiology

    Greenville, South Carolina, 29607, United States

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