New heart procedure could free AF patients from daily pills
NCT ID NCT05552963
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new device that uses electrical pulses to treat a type of irregular heartbeat called paroxysmal atrial fibrillation. 142 people who had not been helped by standard medications took part. The goal was to see if the procedure could keep their heart rhythm normal for a year without needing anti-arrhythmic drugs.
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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142 people
The number who actually took part.
- Started
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Dec 2022
- Finished
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Dec 2024
- 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: * Diagnosed with symptomatic paroxysmal atrial fibrillation (PAF) (Physician's note indicating recurrent self-terminating atrial fibrillation \[AF\]). At least one electrocardiographically documented AF episode within twelve (12) months prior to enrollment. Electrocardiographic documentation may include, but is not limited to, electrocardiogram (ECG), Holter monitor, or telemetry strip * Failed at least one Class I or Class III antiarrhythmic drug (AAD) as evidenced by recurrent symptomatic AF, contraindicated or intolerable to both Class I and Class III AAD * Able and willing to comply with all pre-procedure, post-procedure, and follow-up testing and visit requirements * Willing and capable of providing consent Exclusion Criteria: * AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (Example, untreated documented obstructive sleep apnea and acute alcohol toxicity) * Previous left atrium (LA) ablation or surgery * Participants known to require ablation outside the pulmonary vein (PV) region (atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, atrial tachycardia, atrial flutter of unknown origin, ventricular tachycardia and Wolff-Parkinson-White) * Previously diagnosed with persistent AF (greater than \[\>\] 7 days in duration) * Severe dilatation of the LA (documented LAD \>50 millimeters \[mm\] antero-posterior diameter by transthoracic echocardiography (TTE) within 6 month prior to enrollment)
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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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Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
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Shanghai General Hospital
Shanghai, Shanghai Municipality, China
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The first affiliated hospital of Dalian Medical University
Dalian, Liaoning, China
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The first affiliated hospital of Zhengzhou University
Zhengzhou, Henan, China
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Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
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West China Hospital of Sichuan University
Chengdu, Sichuan, China