Stroke Trial, Recruiting NCT06060912 Sponsor: Deutsches Herzzentrum Muenchen Condition: Stroke
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Stroke Trial, Recruiting

NCT06060912
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 who are able to give their own consent to participate
  • People who have been diagnosed with a type of irregular heartbeat called atrial fibrillation or atrial flutter (which comes and goes, is ongoing, or is permanent) and who are not caused by a heart valve problem, and who have a higher-than-average risk of stroke based on a scoring system called CHA2DS2-VASc (a score of 2 or more for men, or 3 or more for women)
  • People whose treating doctor has determined they are not suitable for long-term blood-thinning medication taken by mouth
  • People whose treating doctor has assessed them as suitable for a minimally invasive procedure to close off a small pouch in the heart called the left atrial appendage (LAA)
  • People who are able to follow the required medication plan after the heart procedure
  • People who have provided written agreement to take part in the trial
  • People whose heart anatomy is compatible with either of the two specific devices being studied in this trial (both devices must be suitable based on the heart's shape and size)
  • Women who could become pregnant must have a negative pregnancy test before joining and agree to use reliable contraception throughout the study

Who may not be able to join:

  • People who need long-term blood-thinning medication for a reason other than atrial fibrillation, such as a blood clot in the lungs or a mechanical heart valve
  • People whose left atrial appendage (the heart pouch targeted in this procedure) has already been closed off or surgically tied
  • People with a known allergy or sensitivity to any materials used in the devices or the required medications
  • People who have previously had a repair or a device implanted to close a hole between the upper chambers of the heart (called an atrial septal defect)
  • People with an active heart infection or another infection that has spread bacteria into the bloodstream
  • People with significant narrowing of the arteries in the neck causing symptoms
  • People already taking part in another clinical trial that could affect the results of this one
  • People who are unable to follow or complete the trial requirements for any reason
  • People found on heart imaging (ultrasound) to have a blood clot inside the heart
  • People found on heart imaging to have a tumour inside the heart
  • People found on heart imaging to have a significant fluid build-up around the heart
  • People found on heart imaging to have significant narrowing of the mitral heart valve

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 14 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: Michael Joner, MD, Klinik für Herz- und Kreilauferkankungen, Deutsches Herzzentrum München

Phone: +4989-1218-2869

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
Deutsches Herzzentrum Muenchen
Registry
ClinicalTrials.gov
Start date
5 December 2023
Est. completion
15 January 2026

Where this trial is recruiting

🇩🇪 Germany

Primary endpoints

PDL size after 3 months

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: 14 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