New zap-and-heal heart device tested in first human study
NCT ID NCT07452211
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new device that uses short electrical pulses to treat a type of irregular heartbeat called paroxysmal atrial fibrillation. Ten patients received the procedure to see if it was safe and could stop the heart rhythm problem for at least 12 months. The goal was to check if the device could effectively isolate the veins that trigger the irregular beats.
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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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10 people
The number who actually took part.
- Started
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Dec 2020
- Finished
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Apr 2022
- 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 75 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. Patients aged 18 to 75 years old; 2. Patients diagnosed with symptomatic paroxysmal atrial fibrillation: (The medical records documented recurrent and self-terminating atrial fibrillation).Electrocardiographic recordings may include, but are not limited to, electrocardiography (ECG), ambulatory ECG monitoring, or telemetric ECG. 3. Capable and willing to comply with all preoperative and postoperative follow-up examinations and requirements. 4. Able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the subject him/herself. Exclusion Criteria: 1. AF secondary to electrolyte imbalance, thyroid disease, or reversible cause; 2. AF episodes lasting more than 7 days; 3. History of previous AF ablation therapy; 4. Previous valve repair, replacement or artificial valve implantation; previous atrial septal defect closure, patent foramen ovale closure cardiac intervention or surgery; 5. Any myocardial infarction (MI), coronary artery bypass grafting (CABG) procedure or percutaneous coronary intervention (PCI) during the 3-month interval preceding the consent date; 6. Hypertrophic Obstructive Cardiomyopathy (HOCM); 7. NYHA class III and IV; 8. Presence of implanted ICD, CRT; 9. Documented active thrombus in the left atrium or atrial appendage on imaging; 10. Any carotid artery stent implantation or endarterectomy within the previous 6 months; 11. Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gas or severe breathing difficulties; 12. Known pulmonary vein stenosis 13. Contraindication to isoproterenol therapy. 14. Anticoagulation contraindications, and history of blood clotting or bleeding abnormalities; 15. Patients with acute systemic infection; 16. (eGFR)\< 60mL/min/1.73m2, or have a history of kidney dialysis; 17. Women who are pregnant and/or breast feeding or unable to use contraception during the trial; 18. Enrollment in another clinical trial evaluating other devices or drugs during the same period; 19. Life expectancy less than 12 months (such as patients with advanced cancer); 20. Abnormalities or diseases that the investigator considers to be excluded from the study's coverage.
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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.
Contacts and locations
Locations
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Fuwai Yunnan Hospital
Kunming, Yunnan, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new mapping and ablation system fix recurring atrial fibrillation?
- Can a new catheter zap away irregular heartbeats?
- Which imaging guide leads to better outcomes in heart ablation?
- 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