Could a simple heart procedure free millions from daily blood thinners?
NCT ID NCT06615596
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether people with atrial fibrillation (AF) can safely stop taking blood thinners after a successful catheter ablation procedure. About 3,160 adults who have been free of AF for 6 to 12 months after ablation will be randomly assigned to either continue or stop their blood thinners. Smart wearable devices will monitor for any return of AF, and participants will be followed for two years to compare rates of stroke, bleeding, and other events.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- discontinuation of anticoagulation therapy
- What this could lead to
- If successful, this could change guidelines so that many AF patients can safely stop taking blood thinners after ablation, reducing bleeding risks.
- What could go wrong
- This is an early-phase study, and stopping blood thinners may increase the risk of stroke in some patients. The results may not apply to everyone with AF.
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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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 3,160 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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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
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 years and older
- 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: * Age ≥18 years * Diagnosed paroxysmal, persistent, or longstanding persistent AF * Successful procedure (defined as restoration of sinus rhythm after PV isolation for paroxysmal AF, restoration of sinus rhythm after PV isolation and completion of additional ablation for persistent AF, according to 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation) and no recurrence within 3 months of ablation, using a cooled tip RF-, laser- or cryo-balloon-catheter * No periprocedural complications * Signed informed consent * Male with CHA2DS2-VASC score ≥1, female with score ≥2. Exclusion Criteria: * Valvular AF (moderate- severe mitral insufficiency; relevant mitral stenosis with a mean pressure gradient \>5mmHg) * Reversible AF (e.g. uncontrolled hyperthyroidism) * Prior AF ablation (including surgical ablation) * History of left atrial appendage occlusion/ligation/excision * Concomitant surgical ablation * Left atrial diameter \>50 mm * Left atrial or LAA thrombus * Pregnancy/breast feeding * Women of childbearing age who refuse to use a highly effective and medically acceptable form of contraception throughout the study * Patient has a non-arrhythmic condition necessitating long-term oral anticoagulation (i.e. PE, ventricular thrombus, peripheral thrombosis, etc) * Recent myocardial infarction, NYHA class IV heart failure, patent foramen ovale, recent trauma or other prothrombotic conditions * Patient with special risk factors for stroke unrelated to AF, specifically known thrombophilia/ hypercoagulability, uncontrolled hypertension (systolic blood pressure \>180 mmHg and/or diastolic blood pressure \>100 mmHg within 4 days of enrollment), untreated familial hyperlipidemia, known vascular anomaly (intracranial aneurysm/ arteriovenous malformation or chronic vascular dissection), or known severe carotid disease. * Patient has bleeding contra-indication to oral anticoagulation (such as bleeding diathesis, hemorrhagic disorder, significant gastrointestinal bleeding within 6 months, intracranial/intraocular/ atraumatic bleeding history, fibrinolysis within 48 hours of enrollment). * Patient has other contraindication to oral anticoagulation or treatment with antiplatelet agent * Patient has been on strong CYP3A inducers (such as rifampicin, phenytoin, phenobarbital, or carbamazepine) or strong CYP3A inhibitors (such as ketoconazole or protease inhibitors) within 4 days of enrolment * Structural congenital heart disease * Recent stroke or intracranial hemorrhage within 6 months * Inability to adequately understand nature, significance, implications and risks of study precipitation and to comply with follow-up (i.e. bipolar disorders, severe depression, suicidal tendencies, among others) as judged by the local physician, ongoing drug or alcohol addiction (\> 8 drinks/week) * Patients who are \> 85 years of age * Patients who are critically ill or who have a life expectancy \<3 years * Patient is unable or unwilling to provide informed consent * Patient is included in another randomized clinical trial or a clinical trial requiring an insurance
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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
12 sites in 2 countries. 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
NOT_YET_RECRUITINGBeijing, Beijing Municipality, 100011, China
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Brigham and Women Hospital
NOT_YET_RECRUITINGBoston, Massachusetts, 02115, United States
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Fuwai Central China Cardiovascular Hospital
NOT_YET_RECRUITINGZhengzhou, Henan, China
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Fuwai Hospital
RECRUITINGBeijing, Beijing Municipality, 100037, China
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Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen
RECRUITINGShenzhen, Guangdong, China
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Shanghai Chest Hospital
NOT_YET_RECRUITINGShanghai, Shanghai Municipality, China
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Shanxi Cardiovascular Hospital (Shanxi Cardiovascular Research Institute)
NOT_YET_RECRUITINGTaiyuan, Shanxi, China
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Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
RECRUITINGHangzhou, Zhejiang, China
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The First Affiliated Hospital, Sun Yat-sen University
NOT_YET_RECRUITINGGuangzhou, Guangdong, China
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West China Hospital, Sichuan University
NOT_YET_RECRUITINGChengdu, Sichuan, China
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Wuhan Asia Heart Hospital
RECRUITINGWuhan, Hubei, China
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Yunnan Fuwai Cardiovascular Hospital
NOT_YET_RECRUITINGKunming, Yunnan, China
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