Atrial Fibrillation Trial, Recruiting NCT04559243 Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd. Condition: Atrial Fibrillation
Back to Atrial Fibrillation

Atrial Fibrillation Trial, Recruiting

NCT04559243
Recruiting Not Applicable

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 aged 18 or older, of any gender
  • People who are able to understand what the study involves, are willing to take part voluntarily, sign a consent form, and attend follow-up visits as required
  • People who have a medical need for a procedure to close off a part of the heart called the left atrial appendage
  • People who have a type of irregular heartbeat (atrial fibrillation) that is not caused by a heart valve problem, and who have previously had a blood clot-related event linked to their irregular heartbeat, and who also meet at least one of the following conditions:
    • A bleeding risk score of 3 or more on a standard medical assessment tool called HAS-BLED
    • A situation where long-term use of blood-thinning medications is not considered appropriate
    • Difficulty consistently taking blood-thinning medications as prescribed
    • A stroke risk score of 2 or more on a standard medical assessment tool called CHA2DS2-VASc

Who may not be able to join:

  • People whose irregular heartbeat is caused by a heart valve problem, such as moderate to severe narrowing of the mitral valve or having had a mechanical heart valve replacement
  • People whose irregular heartbeat is a first occurrence, or where a clear reversible cause has been identified
  • People who have a blood clot present in the left side of the heart, or a clot in an area of the heart called a left ventricular aneurysm
  • People who have had a certain type of serious heart attack (ST elevation myocardial infarction) within the past 3 months
  • People whose heart function has been assessed as being at the most severe level (Grade IV) using a standard medical classification system
  • People who are allergic to, or cannot safely use, a metal material called nitinol, aspirin, clopidogrel, heparin, or other blood-thinning medications
  • People who are pregnant or planning to become pregnant during the study period
  • People who are currently taking part in another clinical trial for a drug or medical device that has not yet finished
  • People who have had a stroke or a brief stroke-like event (sometimes called a TIA) within the past 30 days, or a major bleeding event within the past 14 days
  • People for whom the left atrial appendage closure procedure is not suitable, or who the trial doctor considers inappropriate for the study for any other reason
  • People who have had a confirmed blood clot-related event in the past

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.
Last synced 23 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Chenyang Jiang, Doctor, Sir Run Run Shaw Hospital

Phone: 8613857190051

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
Not Applicable
Sponsor
Lifetech Scientific (Shenzhen) Co., Ltd.
Registry
ClinicalTrials.gov
Start date
12 November 2020
Est. completion
1 November 2025

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Incidence of new ischemic stroke, systemic embolism, and cardiac death 12 months after operation; Incidence of major bleeding events (intracranial or gastrointestinal, or any bleeding requiring transfusion of ≥ 2 units of red blood cells) at 12 months after operation

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 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.

View original record on ClinicalTrials.gov