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Heart device tested in Real-World AF patients

NCT ID NCT05434650

Disease control Sponsor: Abbott Medical Devices 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 200 people with persistent atrial fibrillation (AF) who undergo a heart procedure using Abbott's ablation catheter. The catheter uses heat to scar tiny areas in the heart and block faulty electrical signals. Researchers track how many patients stay free of AF for up to 3 years, and check for serious side effects within a week of the procedure.

What this could mean

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

Active substance
Abbott Ablation Catheter (TactiCath SE) delivering radiofrequency energy
What this could lead to
If successful, this could confirm that the ablation device is a safe and effective long-term option for controlling atrial fibrillation without needing lifelong medication.
What could go wrong
This is a post-approval study, not a new breakthrough. The procedure carries risks like heart damage, stroke, or bleeding. Success depends on patient selection and real-world conditions.

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

200 people

The number who actually took part.

Started

Oct 2022

Expected to finish

Nov 2026

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

This clinical investigation will enroll subjects of all genders who have drug refractory, symptomatic, persistent AF.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: 1. Subject must provide written informed consent prior to any clinical investigation-related procedure. 2. Documented symptomatic persistent AF, which is defined as continuous AF sustained beyond 7 days and less than 1 year that is documented by a physician's note AND one of the following: 1. a 24-hour Holter within 180 days prior to consent/enrollment, showing continuous AF OR 2. two electrocardiograms (from any form of rhythm monitoring) showing continuous AF: i. that are taken at least 7 days apart but less than 12 months apart. ii. If electrocardiograms are more than 12 months apart, there must be one or more SR recordings in between or within 12 months prior to consent/enrollment NOTE: The most recent ECG must be within 180 days of consent/enrollment. Documented evidence of the AF episode must either be continuous AF on a 12-lead ECG or include at least 30 seconds of AF from another ECG device. 3. Subject must have failed, intolerance, or contraindication to a Class I-IV AAD medication. 4. Able and willing to comply with all pre-, post-, and follow-up testing and requirements Exclusion Criteria: 1. Previously diagnosed continuous AF \>12 months (longstanding persistent AF) 2. Previous left atrial surgical or catheter ablation for atrial fibrillation or a previous procedure that required an incision in the left atrium with resulting scar 3. Documented or known intracardiac thrombus on imaging 4. History of atriotomy or ventriculotomy within 4 weeks prior to the initial procedure 5. Patients with prosthetic valves 6. Diagnosed atrial myxoma 7. Acute illness or active systemic infection or sepsis 8. Patient is unlikely to survive the protocol follow up period of 36 months 9. Presence of 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 10. Enrollment in an investigational study evaluating another device, biologic, or drug that may interfere with this clinical investigation at the time of the initial procedure or within 30 days prior to the initial procedure 11. Investigator deems at the time of screening for inclusion in the study that the patient's treatment plan does not or likely will not include use of the study catheter

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Conditions

The condition(s) this trial relates to.

atrial fibrillation atrial tachycardia persistent atrial fibrillation

As listed by the trial registrant

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

Atrial arrhythmia Atrial tachycardia Atrium; fibrillation

Contacts and locations

Locations

  • Arkansas Cardiology

    Little Rock, Arkansas, 72205, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Centennial Medical Center

    Nashville, Tennessee, 37203, United States

  • Chippenham Hospital

    Richmond, Virginia, 23225, United States

  • Doylestown Hospital

    Doylestown, Pennsylvania, 18901, United States

  • Eisenhower Medical Center

    Rancho Mirage, California, 92270, United States

  • Erlanger Medical Center

    Chattanooga, Tennessee, 37403, United States

  • Heart Center Research, LLC.

    Huntsville, Alabama, 35801, United States

  • Methodist Hospital of San Antonio

    San Antonio, Texas, 78229, United States

  • North Mississippi Medical Center

    Tupelo, Mississippi, 38801, United States

  • Northside Hospital

    Atlanta, Georgia, 30342, United States

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121, United States

  • Oklahoma Heart Hospital South

    Oklahoma City, Oklahoma, 73135, United States

  • Providence Hospital

    Southfield, Michigan, 48075, United States

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507, United States

  • Sequoia Hospital

    Redwood City, California, 94062, United States

  • St. Marks Hospital

    Salt Lake City, Utah, 84124, United States

  • St. Patrick Hospital

    Missoula, Montana, 59802, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

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