Heart patients may ditch blood thinners after ablation, major trial investigates
NCT ID NCT06871228
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 heart ablation procedure. About 4,100 adults aged 18-80 who have been on blood thinners for at least 2 months after ablation and have no signs of AF recurrence will be randomly assigned to either stop or continue their medication. All participants will use smartwatches and regular heart monitors to catch any return of AF. The goal is to see if stopping blood thinners reduces bleeding risks without increasing the chance of stroke or death.
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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 4,100 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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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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 Participants must meet all of the following criteria: 1. Age 18 to 80 years. 2. 60±15 to 365±15 days after atrial fibrillation/atrial flutter (AF/AFL) ablation. 3. CHA2DS2-VA score ≥2. 4. No history of stroke, transient ischemic attack (TIA), or systemic embolism. 5. Continuous use of a NOAC since AF/AFL ablation. 6. No documented atrial tachyarrhythmia recurrence since ablation. 7. No antiarrhythmic drug (AAD) use within the past 2 months. 8. Able and willing to provide written informed consent. 9. Able and willing to comply with study procedures and follow-up. Exclusion Criteria Participants will be excluded if any of the following criteria are present: 1. High risk of post-ablation recurrence (e.g. including premature atrial contraction burden \>3% on any ambulatory ECG/Holter recording). 2. Moderate-to-severe mitral stenosis (mitral valve area ≤2.0 cm²) or mechanical heart valve. 3. Increased bleeding risk, including any of the following: 1. Current ISTH major bleeding or clinically relevant non-major bleeding (CRNMB). 2. History of non-traumatic major bleeding (e.g., intracranial, intraocular, spinal, retroperitoneal, gastrointestinal, or intra-articular) unless the reversible cause has been permanently eliminated. 3. Unresolved intracranial aneurysm/vascular malformation, or active/unhealed gastric or duodenal ulcer. 4. General anesthesia surgery within the past 3 months. 5. Planned surgery within the next 3 months. 6. Known bleeding diathesis (e.g., hemophilia). 7. Uncontrolled hypertension (SBP \>180 mmHg and/or DBP \>110 mmHg). 8. Hemoglobin \<90 g/L or blood transfusion within 4 weeks prior to enrollment. 9. Platelet count \<50 × 10⁹/L. 10. End-stage kidney disease (eGFR \<15 mL/min/1.73 m²) or on dialysis. 11. Severe liver disease (e.g., esophageal variceal bleeding, ascites, hepatic encephalopathy, or jaundice). 12. Known intolerance to oral anticoagulants or contraindication to oral anticoagulation. 4. Any condition requiring continued oral anticoagulation (e.g., pulmonary embolism, deep vein thrombosis, hypertrophic cardiomyopathy, cardiac amyloidosis). 5. Conditions associated with high non-cardioembolic stroke risk, including carotid, vertebral, or intracranial arterial stenosis ≥70%. 6. Prior left atrial appendage (LAA) occlusion, surgical LAA excision/closure, or intraoperative confirmation of LAA electrical isolation. 7. Female participants who are pregnant or breastfeeding, or of childbearing potential not using effective contraception. 8. Life expectancy \<2 years. 9. Current participation in another interventional clinical trial. 10. Any condition that, in the investigator's judgment, would make the participant unsuitable for the 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.
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
22 sites. 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
RECRUITINGBeijing, Beijing Municipality, 100029, China
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Chengdu Fifth People's Hospital
NOT_YET_RECRUITINGChengdu, Sichuan, 611130, China
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First Affiliated Hospital of Dalian Medical University
NOT_YET_RECRUITINGDalian, Liaoning, 116023, China
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Guangdong Provincial People's Hospital
NOT_YET_RECRUITINGGuangzhou, Guangdong, 510080, China
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Henan Provincial Chest Hospital
NOT_YET_RECRUITINGZhengzhou, Henan, 450003, China
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Liaocheng Heart Hospital
NOT_YET_RECRUITINGLiaocheng, Shandong, 252299, China
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Liaocheng People's Hospital
NOT_YET_RECRUITINGLiaocheng, Shandong, 252000, China
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Luohe Central Hospital
NOT_YET_RECRUITINGLuohe, Henan, 462003, China
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Ningbo No.2 Hospital
NOT_YET_RECRUITINGNingbo, Zhejiang, 315000, China
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Qilu Hospital of Shandong University
NOT_YET_RECRUITINGJinan, Shandong, 250012, China
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Shengjing Hospital Affiliated to China Medical University
NOT_YET_RECRUITINGShenyang, Liaoning, 110004, China
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Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
NOT_YET_RECRUITINGHangzhou, Zhejiang, 310009, China
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The Affiliated Hospital of Xuzhou Medical University
NOT_YET_RECRUITINGXuzhou, Jiangsu, 221002, China
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The First Affiliated Hospital of Anhui Medical University
NOT_YET_RECRUITINGHefei, Anhui, 230022, China
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The First Affiliated Hospital of Harbin Medical University
NOT_YET_RECRUITINGHarbin, Heilongjiang, 150001, China
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The First Affiliated Hospital of Nanjing Medical University
NOT_YET_RECRUITINGNanjing, Jiangsu, 210036, China
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The First Affiliated Hospital of Zhejiang University School of Medicine
NOT_YET_RECRUITINGHangzhou, Zhejiang, 310000, China
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The First Hospital of Jilin University
NOT_YET_RECRUITINGChangchun, Jilin, 130021, China
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The Second Affiliated Hospital of Harbin Medical University
NOT_YET_RECRUITINGHarbin, Heilongjiang, 150085, China
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The Second Hospital of Hebei Medical University
NOT_YET_RECRUITINGShijiazhuang, Hebei, 050000, China
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Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
NOT_YET_RECRUITINGWuhan, Hubei, 430030, China
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Wuhan Asia Heart Hospital
NOT_YET_RECRUITINGWuhan, Hubei, 430022, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a checklist and heart monitor stop repeat strokes?
- Can a breathing workout and walks help dialysis patients with irregular heartbeats?
- Zapping the ear: a new way to stop Post-Surgery heart rhythm problems?
- Can a new mapping and ablation system fix recurring atrial fibrillation?
- Can shedding pounds stop atrial fibrillation in its tracks?
- Pacemaker algorithm tuned to Heart's pumping may beat standard rate response