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Back to Atrial Fibrillation
Early Phase 1 Atrial Fibrillation Trial, Recruiting
NCT06615596
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who are 18 years of age or older (but not older than 85)
- People who have been diagnosed with atrial fibrillation (an irregular heartbeat condition), whether it comes and goes, has lasted a while, or has been ongoing for a long time
- People whose heart was successfully returned to a normal rhythm during an ablation procedure (a treatment that uses heat, laser, or cold energy to correct the irregular heartbeat), with no return of the irregular heartbeat within 3 months after the procedure
- People who had no complications during or immediately after their ablation procedure
- People who have signed a consent form agreeing to participate in the study
- Men who have a stroke risk score of 1 or higher, or women who have a stroke risk score of 2 or higher, based on a standard medical scoring system (confirm with trial site)
Who may not be able to join:
- People whose atrial fibrillation is caused by a significant heart valve problem, specifically a moderate-to-severe leaky mitral valve or a narrowed mitral valve with elevated pressure readings
- People whose atrial fibrillation is caused by a treatable underlying condition, such as an overactive thyroid that is not yet under control
- People who have previously had any type of ablation procedure for atrial fibrillation, including surgery
- People who have previously had a procedure to close off, tie off, or remove the left atrial appendage (a small pouch in the heart)
- People who are having a surgical ablation at the same time as this study
- People whose left chamber of the heart (left atrium) is larger than 50mm in size (confirm with trial site)
- People who have a blood clot in the left side of the heart
- People who are pregnant or breastfeeding
- Women of childbearing age who are unwilling to use a highly effective form of contraception for the duration of the study
- People who need to take blood thinners long-term for a reason other than atrial fibrillation, such as a blood clot in the lungs, a clot in the heart, or clots in other blood vessels
- People who have recently had a heart attack, have severe heart failure, have a small natural hole between the upper chambers of the heart (patent foramen ovale), have recently experienced a significant injury, or have other conditions that increase the risk of blood clots
- People with certain additional stroke risk factors unrelated to their atrial fibrillation, including a known blood clotting disorder, uncontrolled high blood pressure (above 180/100 mmHg within 4 days of enrolling), an untreated inherited high cholesterol condition, a known blood vessel abnormality in the brain, or known severe narrowing of the neck arteries
- People who have a high risk of bleeding that would make taking blood thinners unsafe, such as a bleeding disorder, a significant stomach or bowel bleed in the past 6 months, or a history of bleeding in the brain or eyes
- People who have any other reason they cannot safely take blood thinners or anti-platelet medications
- People who have taken certain specific medications that strongly interact with the study drug within 4 days of enrolling (confirm with trial site for the specific medications involved)
- People who have a structural heart defect present from birth
- People who have had a stroke or bleeding in the brain within the past 6 months
- People who, in the opinion of their doctor, are unable to fully understand the study or follow up with the required visits — including people with certain mental health conditions or ongoing drug or alcohol dependency (more than 8 alcoholic drinks per week)
- People who are critically unwell or whose life expectancy is less than 3 years
- People who are unwilling or unable to provide consent to participate
- People who are already enrolled in another clinical trial that involves randomisation or requires insurance coverage
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.
Contact this trial
Phone: 13901121319
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Recruiting
Phase
Early Phase 1
Sponsor
China National Center for Cardiovascular Diseases
Registry
ClinicalTrials.gov
Start date
5 August 2025
Est. completion
1 January 2029
Where this trial is recruiting
🇨🇳 China
🇺🇸 United States
Primary endpoints
Composite outcome consisting of thromboembolic events and clinically significant bleeding events
Can't join this trial?
Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.