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New zap-and-heal heart device tested in first human study

NCT ID NCT07452211

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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.

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

10 people

The number who actually took part.

Started

Dec 2020

Finished

Apr 2022

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 75 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. 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

  • Fuwai Yunnan Hospital

    Kunming, Yunnan, China

More trials for these conditions

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