Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New heart zapping technique could free patients from irregular rhythm

NCT ID NCT07575828

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a new device that uses short electrical pulses to treat atrial fibrillation (AF), a common heart rhythm problem. About 320 adults with AF will receive this procedure to see if it safely restores normal heart rhythm for at least a year. The goal is to reduce symptoms and the need for long-term medication.

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 320 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Mar 2029

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. Adults who are ≥18 and ≤80 years of age on the day of enrollment (or older than 18 if required by local law) 2. A diagnosis of recurrent symptomatic paroxysmal or persistent AF: Symptomatic paroxysmal AF: AF that terminates spontaneously or with intervention within 7 days of onset, documented by the following: 1. Physician's note indicating at least 2 symptomatic paroxysmal AF episodes occurring within 12 months prior to enrollment; AND 2. at least 1 ECG documented AF episode from any form of rhythm monitoring within 12 months prior to enrollment. Symptomatic persistent AF: Continuous AF sustained beyond 7 days and less than 1 year, documented by the following: 1. Physician's note indicating at least 1 symptomatic persistent AF episode occurring within 12 months prior to enrollment; AND 2. any 24-hour continuous ECG recording documenting continuous AF within 12 months prior to enrollment; OR 2 ECGs from any form of rhythm monitoring taken at least 7 days apart, both showing continuous AF within 12 months prior to enrollment 3. Willing and able to comply with all baseline and follow-up evaluations for the full length of the study. Exclusion Criteria: 1. Long-standing persistent AF (continuous AF that is sustained \>12 months) 2. Paroxysmal AF patients: AF that required three (3) or more distinct cardioversions in the preceding 12 months. 3. Paroxysmal AF: LA anteroposterior diameter \> 5.0 cm (by MRI, CT, or TTE) Persistent AF: LA anteroposterior diameter \> 5.5 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. 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) 7. Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the ablation procedure 8. Contraindication to or unwillingness to use systemic anticoagulation 9. Presence of any pulmonary vein stents 10. Known pre-existing pulmonary vein stenosis 11. Prior valvular (surgical or percutaneous) procedure including prosthetic, bioprosthetic, valve replacement, valve repair or valvuloplasty, and any prior atriotomy 12. Moderate to severe mitral valve or aortic 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 abnormal blood gases or requiring supplemental oxygen 18. Rheumatic heart disease 19. Severe thrombocytosis, thrombocytopenia, or any bleeding or clotting disorder 20. Documented left atrial thrombus on imaging 21. Active systemic infection or sepsis 22. Hypertrophic cardiomyopathy 23. Known reversible causes of AF, including but not limited to uncontrolled hyperthyroidism, severe untreated obstructive sleep apnea, and acute alcohol toxicity 24. Any cerebral ischemic event (strokes or TIAs) which occurred during the 6-month interval preceding the consent date 25. Carotid stenting or endarterectomy 26. History of thromboembolic event within the past 6 months or evidence of intracardiac thrombus at the time of the procedure 27. 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 28. Patient with life expectancy that makes it unlikely 12 months of follow-up will be completed 29. 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 30. Known allergies or hypersensitivities to adhesives 31. Body mass index \> 40 kg/m2 32. Atrial myxoma 33. Significant restrictive or obstructive pulmonary disease or chronic respiratory condition. 34. 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 35. Solid organ or hematologic transplant, or currently being evaluated for an organ transplant 36. Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation 37. Known drug or alcohol dependency 38. 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 39. Amyloid heart disease (cardiac amyloidosis)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Paroxysmal atrial fibrillation (PAF) are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

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