Atrial Fibrillation Trial, Recruiting NCT04298723 Sponsor: Jena University Hospital Condition: Atrial Fibrillation
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Atrial Fibrillation Trial, Recruiting

NCT04298723
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 who are able and willing to give written consent to take part in the trial
  • People who have a confirmed diagnosis of atrial fibrillation (an irregular heart rhythm), of any type — including paroxysmal, persistent, long-standing persistent, or permanent
  • People with a CHA2DS2VASc score of 2 or higher — a score doctors use to measure stroke risk in people with atrial fibrillation (confirm with trial site)
  • People who had a bleed inside the skull (brain bleed) more than 6 weeks ago
  • People whose left atrial appendage (a small pouch in the heart) has a shape that is suitable for the procedure
  • People whose anatomy makes them a suitable candidate for a left atrial appendage closure device, as determined by the treating doctor
  • People aged 18 years or older

Who may not be able to join:

  • People who have other medical conditions — apart from atrial fibrillation — that require them to take blood-thinning medication long-term, such as having a mechanical heart valve or a hereditary clotting disorder
  • People who have carotid artery disease (narrowing of the neck arteries) causing symptoms, if that condition has not yet been treated
  • People who have a blood clot in the left side of the heart or in the left atrial appendage
  • People who have an active infection, active heart valve infection (endocarditis), or another infection that has spread bacteria into the bloodstream
  • People with significant physical or neurological disability, as measured by a standard disability scale (modified Rankin Scale score of 4 or higher) (confirm with trial site)
  • People with severe liver disease or liver failure affecting blood clotting (classified as Child-Pugh class C)
  • People who are pregnant or breastfeeding
  • People who are currently taking part in another interventional clinical trial, or who have taken part in one within the 30 days before joining this trial
  • People with a known serious illness where life expectancy is less than one year, including those with end-stage heart failure
  • People who are confined to an institution by a legal or court order
  • People who have a cardiac or non-cardiac surgery or procedure planned in the near future (though eligibility may be reconsidered 30 days after that surgery or procedure has taken place)

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 15 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: Sven Möbius-Winkler, Prof. Dr., Department of Internal Medicine I, Jena University Hospital

Phone: +4936419324503

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Jena University Hospital
Registry
ClinicalTrials.gov
Start date
16 June 2020
Est. completion
1 June 2029

Where this trial is recruiting

🇩🇪 Germany 🇵🇱 Poland

Primary endpoints

Event free survival of the composite of cardiovascular or unexplained death, stroke (including ischemic or hemorrhagic stroke), systemic embolism, bleeding (BARC type 2-5); Event free survival of the composite of cardiovascular or unexplained death, stroke (including ischemic or hemorrhagic stroke), systemic embolism, bleeding (BARC type 2-5); Event free survival of the composite of cardiovascular or unexplained death, stroke (including ischemic or hemorrhagic stroke), systemic embolism, bleeding (BARC type 2-5); Event free survival of the composite of cardiovascular or unexplained death, stro...

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: 15 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