Can a new catheter zap away irregular heartbeats?
NCT ID NCT07789925
First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time
Summary
This trial tests whether the Sphere-9 catheter and Affera system can safely and effectively treat paroxysmal atrial fibrillation (PAF), a condition where the heart beats irregularly. Adults with PAF who have not been helped by or cannot take certain heart medications will receive catheter ablation, a procedure that uses energy to isolate the pulmonary veins. Researchers will check if participants stay free from atrial fibrillation and other abnormal rhythms for 12 months after the procedure, and they will monitor for serious side effects for 6 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Catheter ablation using the Sphere-9 catheter and Affera integrated mapping and ablation system
- What this could lead to
- If it works, this could offer a safer, more effective way to treat paroxysmal atrial fibrillation, helping people stay free from irregular heart rhythms without relying on daily medications.
- What could go wrong
- This is an early-stage trial in China, and the procedure carries risks like bleeding, infection, or heart damage. Success is not guaranteed, and results may not apply to all patients.
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
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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
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About 180 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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. Failure of, intolerance to, or contraindication to at least one Class I-IV AAD for the treatment of PAF, as evidenced by recurrent symptomatic AF. 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, , or any type of implantable cardiac defibrillator (with or without biventricular pacing function), , or presence of a loop recorder or insertable cardiac monitor (ICM) that has not reached manufacturer-defined end of service (or equivalent end-of-life state) 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.
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.
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The places running it
10 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
Contacts and locations
Locations
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Chinese People's Liberation Army Northern Theater Command General Hospital
Shenyang, China
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Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China
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Guangdong Province People's Hospital
Guangzhou, China
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Jiangsu Province Hospital
Nanjing, China
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Nanjing Drum Tower Hospital
Nanjing, China
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Shanghai Jiao Tong University School of Medicine Ruijin Hospital
Shanghai, China
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The Fisrt Affliated Hopital of Xinjiang Medical Universtiy
Ürümqi, China
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The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, China
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Tianjin Chest Hospital
Tianjin, China
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West China Hospital Sichuan University
Chengdu, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Ablation without X-Rays: a new way to fix irregular heartbeats?
- Smart pacemaker aims to catch and stop heart flutter before it starts
- New heart zapping technique could free patients from irregular rhythm
- New heart zapping device could free patients from irregular heartbeat
- New zap-and-heal heart device tested in first human study