New heart zapping technique could free patients from irregular rhythm
NCT ID NCT07575828
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 Hide 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.
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.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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.
- Two ways to quiet a racing heart: trial pits hybrid ablation against standard catheter treatment
- Can a new mapping and ablation system fix recurring atrial fibrillation?
- Extra vein ablation tested to keep persistent AFib from returning
- Duel of ablation catheters: which wins for persistent AF?
- Can a new drug stop long atrial fibrillation episodes?
- Can a new catheter zap away irregular heartbeats?