Zap away heart flutters: new device trial offers hope for AF patients
NCT ID NCT07586176
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new device that uses special electrical pulses to treat paroxysmal atrial fibrillation, a condition where the heart beats irregularly. About 150 adults aged 18-75 who have not responded well to medication will receive the treatment. The goal is to see if the device can safely restore normal heart rhythm for at least 12 months.
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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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152 people
The number who actually took part.
- Started
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Oct 2024
- Expected to finish
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Sep 2026
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 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 18 years of age ≤75 years of age 2. The clinical diagnosis was paroxysmal atrial fibrillation 3. The disease recurred and the symptoms were obvious before enrollment 4. Atrial fibrillation was recorded by body surface electrocardiogram or by dynamic electrocardiogram (including single-lead electrocardiograph) for ≥30 s within 1 year before admission; 5. Ineffective or intolerance after treatment with at least one Class I or III antiarrhythmic drug 6. Fully understand the treatment plan, and voluntarily sign informed consent, willing to carry out the examination, surgery and follow-up required by the plan. Exclusion Criteria: 1\) Patients who had undergone surgery for atrial fibrillation 2) Left atrial thrombus 3) Patients of childbearing age who could not take effective contraceptive measures during the 12 months after enrollment 4) Anterior and posterior diameter of left atrium ≥50mm 5) Left ventricular ejection fraction (LVEF) ≤40% 6) Atrial fibrillation caused by hyperthyroidism or non-cardiac causes 7) Past atrial septal repair or atrial myxoma 8) Carry active implants (such as pacemakers, ICDs, etc.) 9) NYHA Grade ⅲ-ⅳ cardiac function 10) Patients with definite cerebrovascular diseases within the last 6 months (including cerebral hemorrhage, stroke, and short stroke) Transient ischemic attack) 11) Cardiovascular events within the last 3 months (including acute myocardial infarction, coronary intervention or heart bypass surgery, prosthetic valve replacement or repair, atrial or ventricular otomy) 12) Acute or severe systemic infection 13) Patients with severe liver and kidney diseases, malignant tumors and end-stage diseases, which researchers believe may interfere with the treatment, evaluation and compliance of this trial 14) Patients with obvious bleeding tendency, hypercoagulability and serious blood system diseases 15) Patients who had participated or were participating in other clinical trials within the 3 months prior to enrollment 16) Patients with other conditions deemed inappropriate by the investigator to participate in this study.
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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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West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a new drug stop long atrial fibrillation episodes?
- Can a new heart ablation technique work without x-rays?
- Can targeted electrical pulses quiet an erratic heartbeat?
- New heart ablation technique could tame dangerous rhythms in adults born with heart defects