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New heart tool aims to stop AFib Flare-Ups

NCT ID NCT07308847

Disease control Sponsor: Medtronic Cardiac Ablation Solutions 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 03, 2026 · Updated 5 times

Summary

This study tests a new device that uses heat to destroy tiny areas in the heart causing short bursts of irregular heartbeat (paroxysmal atrial fibrillation). About 300 adults with this condition will receive the procedure and be monitored for a year. The goal is to see if the treatment safely prevents repeat episodes and improves quality of life.

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

300 people

The number who actually took part.

Started

Jan 2026

Expected to finish

Sep 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.

Ages

18 to 80 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. A diagnosis of recurrent symptomatic PAF, which is defined as continuous AF episode lasting longer than 30 seconds but terminates spontaneously or with intervention within 7 days of onset, documented by the following: 1. a physician's note indicating at least 2 symptomatic PAF episodes occurring within 6 months prior to enrollment; and 2. at least 1 electrocardiographically documented episode within 12 months prior to enrollment 2. Adults who are ≥18 and ≤80 years of age on the day of enrollment. 3. Willing and able to comply with all baseline and follow-up evaluations for the full length of the study. Exclusion Criteria: 1. Continuous AF lasting more than 7 days. This includes persistent atrial fibrillation (PsAF) (both early or long-standing) by diagnosis or continuous duration \> 7 days 2. AF that required three (3) or more distinct cardioversions in the preceding 12 months. 3. LA anteroposterior \> 5.0 cm (by MRI, CT, or TTE) 4. Any of the following procedures, implants, or conditions at baseline: prior left atrial catheter or surgical ablation, prior left atrial percutaneous interventions including left atrial appendage occlusion, and septal closure devices 5. Planned LAA closure procedure or implant of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function) for any time during the follow-up period 6. Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the ablation procedure 7. Presence of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function) 8. Presence of any pulmonary vein stents 9. Known pre-existing pulmonary vein stenosis 10. Pre-existing hemidiaphragmatic paralysis 11. Prior valvular (surgical or percutaneous) procedure including prosthetic, bioprosthetic, valve replacement, valve repair or valvuloplasty, and any prior atriotomy 12. Moderate to severe aortic or mitral valve stenosis 13. Moderate to severe mitral regurgitation (i.e., 3+ or 4+ MR) 14. Any cardiac surgery, myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during the 3-month interval preceding the consent date 15. Unstable angina 16. NYHA Class III or IV congestive heart failure or documented left ventricular ejection fraction (LVEF) less than or equal to 40% measure by acceptable cardiac testing (e.g. TTE), or planned transplant or left ventricular assist device (LVAD) 17. Severe lung disease, primary pulmonary hypertension, or any lung disease with abnormal blood gases or requiring supplemental oxygen 18. Rheumatic heart disease 19. Severe thrombocytosis, thrombocytopenia, or any bleeding or clotting disorder 20. Contraindication to or unwillingness to use systemic anticoagulation 21. Documented left atrial thrombus on imaging 22. Active systemic infection or sepsis 23. Hypertrophic cardiomyopathy 24. Known reversible causes of AF, including but not limited to uncontrolled hyperthyroidism, severe untreated obstructive sleep apnea, and acute alcohol toxicity 25. Any cerebral ischemic event (strokes or TIAs) which occurred during the 6-month interval preceding the consent date 26. Carotid stenting or endarterectomy 27. History of thromboembolic event within the past 6 months or evidence of intracardiac thrombus at the time of the procedure 28. Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence 29. Patient with life expectancy that makes it unlikely 12 months of follow-up will be completed 30. Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of the study not pre-approved by Medtronic 31. Known allergies or hypersensitivities to adhesives 32. Body mass index \> 40 kg/m2 33. Atrial myxoma 34. Significant restrictive or obstructive pulmonary disease or chronic respiratory condition. 35. Renal insufficiency with an estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2, or any history of renal failure requiring dialysis or renal transplant 36. Solid organ or hematologic transplant, or currently being evaluated for an organ transplant 37. Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation 38. Known drug or alcohol dependency 39. Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in this study or compliance with follow-up requirements or would impact the scientific soundness of the clinical trial results. 40. Treatment with Amiodarone within the 3 months prior to enrollment 41. Amyloid heart disease (cardiac amyloidosis)

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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 af

Contacts and locations

Locations

  • Arrhythmia Research Group

    Jonesboro, Arkansas, 72401, United States

  • Atrium Health Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157, United States

  • Bethesda North Hospital

    Cincinnati, Ohio, 45220, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042, United States

  • Kansas City Heart Rhythm Institute (Midwest Heart and Vascular Specialist)

    Overland Park, Kansas, 66211, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Rochester, Minnesota, 55902, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404, United States

  • Mercy General Hospital

    Sacramento, California, 95819, United States

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407, United States

  • NCH Rooney Heart Institute

    Naples, Florida, 34102, United States

  • Northwell Health Lenox Hill Hospital

    New York, New York, 10075, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Ohio Health Research and Innovation Institute

    Columbus, Ohio, 43214-3907, United States

  • Scripps Memorial Hospital

    La Jolla, California, 92037, United States

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507, United States

  • Southcoast Health System

    Fall River, Massachusetts, 02720, United States

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas, 78705, United States

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • The Valley Hospital

    Paramus, New Jersey, 07652, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.