New heart procedure could keep AFib away longer
NCT ID NCT07106970
First seen Jun 27, 2026 · Last updated Aug 18, 2026 · Updated 4 times
Summary
This study tests whether adding extra scar lines in the heart, along with the standard vein isolation procedure, helps people with persistent atrial fibrillation stay in normal rhythm longer. About 640 adults aged 18–80 with symptomatic, drug-resistant persistent AFib will be randomly assigned to one of two groups. The goal is to see if the extra ablation reduces the need for repeat procedures or medications.
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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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About 640 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Aug 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.
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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: Study subjects are required to meet all the following inclusion criteria: 1. Subjects with an age range of 18 years or above and 80 years or below. 2. Subjects have symptomatic, drug-resistant, persistent AF, defined as: 1. Symptomatic: these symptoms include but not limited to palpitations, presyncope, syncope, fatigue, and shortness of breath. 2. Drug-resistant: effectiveness failure of, intolerance to, or specific contraindication to at least one AAD. 3. Persistent: continuous AF for \> 90 days, i) with a minimum a physician's note confirming the diagnosis AND,within 180 days of Enrollment Date, either a 24-hour or longer continuous ECG recording confirming continuous AF OR Two ECGs showing continuous AF taken at least 90 days apart. 3. Subjects undergoing a first-time ablation procedure for AF. 4. Subjects who are willing and capable of providing ICF and participating in all testing associated with this study. Exclusion Criteria: 1. AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible/non-cardiac causes. 2. Left atrial anteroposterior diameter ≥ 6.0 cm by transthoracic echocardiography (TTE) within 3 months prior the procedure. 3. Heart failure with left ventricular ejection fraction (LVEF) \< 30% by TTE within 3 months prior the procedure. 4. LA thrombus detected by Transesophageal Echocardiography (TEE) or cardiac CT within one day before the procedure or Intracardiac Echocardiography (ICE) before atrial septal puncture during the procedure. 5. Current or anticipated pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices, mechanical valve, interatrial baffle, closure device, patch, or patent foramen oval occlude, left atrial appendage closure at the time of ablation. 6. Any of the following events within 90 days of the Consent Date: 1. Myocardial infarction, unstable angina or coronary intervention or any cardiac surgery 2. Pericarditis or symptomatic pericardial effusion 3. Gastrointestinal bleeding 4. Stroke, transient ischemic attack (TIA), or intracranial bleeding or any non-neurologic thromboembolic event 7. Contraindication to, or unwillingness to use systemic anticoagulation. 8. Subjects cannot be removed from Class I/III AAD for reasons other than atrial arrhythmia. 9. Women of childbearing potential who are pregnant or lactating. 10. Renal insufficiency if an estimated glomerular filtration rate (eGFR) is \< 30 mL/min/1.73 m2, or with any history of renal dialysis or renal transplant. 11. Conditions that in the investigator's medical opinion would interfere with assessment or therapy, significantly raise the risk of study participation, or modify outcome data or its interpretation. 12. Predicted life expectancy less than 12 months.
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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
1 site. 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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Beijing Anzhen Hospital, affiliated to Capital Medical University
RECRUITINGBeijing, 101118, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two ways to quiet a racing heart: trial pits hybrid ablation against standard catheter treatment
- Extra vein ablation tested to keep persistent AFib from returning
- Duel of ablation catheters: which wins for persistent AF?
- Can a new drug stop long atrial fibrillation episodes?
- Which ablation method wins for tough atrial fibrillation cases?
- Can a diabetes drug keep the heart in rhythm?