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Heart rhythm breakthrough? new ablation device shows promise for AFib

NCT ID NCT06676072

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 completed study tested a new catheter and generator system designed to treat paroxysmal atrial fibrillation (AFib) — a common heart rhythm problem. The device uses pulsed field ablation (PFA) to target and destroy tiny areas of heart tissue causing the irregular rhythm. 188 participants with symptomatic AFib that didn't respond to medication were enrolled. The goal was to see if the procedure is safe and effective at stopping AFib episodes.

What this could mean

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

Active substance
TactiFlex SE ablation catheter and Volt pulsed field ablation generator
What this could lead to
If successful, this could offer a safer, more precise way to treat atrial fibrillation without long-term medication.
What could go wrong
This is a completed early-stage device study with 188 participants. Long-term effectiveness and safety in larger populations are not yet known. Risks include procedure-related complications like bleeding or heart rhythm issues.

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

188 people

The number who actually took part.

Started

Nov 2024

Finished

Apr 2026

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 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: 1. Documented symptomatic paroxysmal atrial fibrillation (PAF). Documentation requirements are as follows: 1. Physician's note indicating recurrent self-terminating AF with ≥ 2 episodes of PAF within the 6 months prior to enrollment AND 2. One electrocardiographically documented PAF episode within 12 months prior to enrollment. NOTE: Documented evidence of the AF episode must either be continuous AF on a 12-lead ECG or include at least 30 seconds of continuous AF from another ECG device. 2. Plans to undergo a catheter ablation procedure due to symptomatic PAF and is refractory, intolerant, or contraindicated to at least one Class I-IV AAD medication 3. At least 18 years of age 4. Able and willing to comply with all trial requirements including pre- procedure, post-procedure, and follow-up testing and requirements 5. Informed of the nature of the trial, agreed to its provisions, and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee (IRB/EC) of the respective clinical trial site. Exclusion Criteria: 1. Previously diagnosed persistent or long-standing persistent atrial fibrillation (Continuous AF greater than 1 year in duration) 2. Arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, electrolyte imbalance, severe untreated sleep apnea, and other major surgical procedures in the preceding 90 days 3. Known presence of cardiac thrombus 4. Left atrial diameter (LAD) \> or equal to 5.0 cm (anteroposterior diameter) within 180 days prior to the index procedure 5. Left ventricular ejection fraction (LVEF) \< or equal to 35% as assessed with echocardiography or computerized tomography (CT) within 180 days prior to the index procedure 6. New York Heart Association (NYHA) class III or IV heart failure 7. Body mass index \> or equal to 40 kg/m2 8. Pregnant or nursing 9. Patients who have had a ventriculotomy or atriotomy within the preceding 28 days of procedure 10. Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 90 days 11. Stroke or TIA (transient ischemic attack) within the last 90 days 12. Heart disease in which corrective surgery is anticipated within 180 days after procedure 13. History of blood clotting or bleeding abnormalities including thrombocytosis, thrombocytopenia, bleeding diathesis, or suspected anti- coagulant state 14. Contraindication to long-term anti-thromboembolic therapy 15. Patient unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation 16. Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication 17. Previous left atrial surgical or left atrial catheter ablation procedure (including left atrial appendage (LAA) closure device) 18. Plans to have an LAA closure device implanted during the follow-up period 19. Presence of any condition that precludes appropriate vascular access 20. Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2) 21. Previous tricuspid or mitral valve replacement or repair 22. Patients with prosthetic valves 23. Patients with a myxoma 24. Patients with an interatrial baffle or patch as the transseptal puncture could persist and produce an iatrogenic atrial shunt 25. Stent, constriction, or stenosis in a pulmonary vein 26. Rheumatic heart disease 27. Hypertrophic cardiomyopathy 28. Active systemic infection 29. Renal failure requiring dialysis 30. Severe pulmonary disease (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms 31. Presence of an implantable therapeutic cardiac device including permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator (with or without biventricular pacing function) or planned implant of such a device for any time during the follow-up period. Presence of an implantable loop recorder is acceptable as long as it is removed prior to insertion of the investigational device. 32. Patient is currently participating in another clinical trial or has participated in a clinical trial within 30 days prior to screening that may interfere with this clinical trial without pre-approval from this study Sponsor 33. Unlikely to survive the protocol follow up period of 12 months 34. Presence of other medical, anatomic, comorbid, 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. 35. Individuals without legal authority 36. Individuals unable to read or write

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Conditions

The condition(s) this trial relates to.

atrial fibrillation paroxysmal atrial fibrillation Recurrence

As listed by the trial registrant

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

Atrial arrhythmia Atrial fibrillation (AF) Drug refractory paroxysmal atrial fibrillation Paroxysmal af

Contacts and locations

Locations

  • AdventHealth Orlando

    Orlando, Florida, 32803, United States

  • Arkansas Heart Hospital

    Little Rock, Arkansas, 72211, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Bryan Heart Medical Center

    Lincoln, Nebraska, 68506, United States

  • Duke University Medical Center

    Durham, North Carolina, 27705, United States

  • Erasmus Medical Center - Thoraxcenter

    Rotterdam, S Holln, 3015 CE, Netherlands

  • HCA Florida Mercy Hospital

    Miami, Florida, 33133, United States

  • Henry Ford Providence Southfield Hospital

    Southfield, Michigan, 48075, United States

  • HonorHealth

    Scottsdale, Arizona, 85258, United States

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Houston Methodist The Woodlands Hospital

    Shenandoah, Texas, 77385, United States

  • KH Wiener Neustadt

    Wiener Neustadt, L Austr, 2700, Austria

  • Kansas City Cardiac Arrhythmia Research Foundation

    Overland Park, Kansas, 66211, United States

  • Loyola University Medical Center

    Maywood, Illinois, 60153, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Medical City Fort Worth

    Fort Worth, Texas, 76104, United States

  • NYU Langone Health

    New York, New York, 10016, United States

  • New York Presbyterian Hospital/Cornell University

    New York, New York, 10021, United States

  • Ocelot Medical Research Group

    Dallas, Texas, 75230, United States

  • Piedmont Athens Regional Medical Center

    Athens, Georgia, 30606, United States

  • South Denver Cardiology Associates PC

    Littleton, Colorado, 80120, United States

  • Stanford University Medical Center

    Stanford, California, 94305, United States

  • Tallahassee Research Institute

    Tallahassee, Florida, 32308, United States

  • Texas Cardiac Arrhythmia

    Austin, Texas, 78705, United States

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • The Heart Institute at Virginia Mason

    Seattle, Washington, 98111, United States

  • The Heart Rhythm Center of MS

    Gulfport, Mississippi, 39501, United States

  • Tristar Centennial Medical Center

    Nashville, Tennessee, 37203, United States

  • University of Michigan Medical Center

    Ann Arbor, Michigan, 48104, United States

  • Vanderbilt Heart & Vascular Institute

    Nashville, Tennessee, 37232, United States

  • Vilnius University Hospital Santariskiu Klinikos

    Vilnius, Dzukija, 08661, Lithuania

  • Virginia Commonwealth University

    Richmond, Virginia, 23219, United States

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