Atrial Fibrillation Trial, Recruiting NCT04628078 Sponsor: Insel Gruppe AG, University Hospital Bern Condition: Atrial Fibrillation
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Atrial Fibrillation Trial, Recruiting

NCT04628078
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:

  • Adults aged 18 or older
  • People with a type of irregular heartbeat called atrial fibrillation (AF) — whether it comes and goes, has lasted a long time, or is ongoing — that is not caused by a heart valve problem, and who have a stroke risk score of 2 or higher on a standard medical scoring system called CHA2DS2-VASc
  • People who are already scheduled for a planned procedure to close off a small pouch in the heart called the left atrial appendage (LAA), which is done to reduce stroke risk
  • People whose heart anatomy is suited to receiving an approved medical device used for this type of closure procedure
  • People who are willing to sign a written consent form agreeing to take part in the study

Who may not be able to join:

  • People who are not willing to sign the consent form agreeing to participate in the study

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 28 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: Lorenz Räber, Prof., Insel Gruppe AG, Inselspital, Universitätsklinik für Kardiologie

Phone: 31 632 09 29

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
Insel Gruppe AG, University Hospital Bern
Registry
ClinicalTrials.gov
Start date
12 August 2015
Est. completion
1 June 2023

Where this trial is recruiting

🇨🇭 Switzerland

Primary endpoints

Primary Safety Endpoint; Primary Efficacy Endpoint - Incidence of cardiovascular death, ischemic stroke and systemic embolism; Secondary Efficacy Endpoint - Incidence of technical success; Feasibility Endpoint - Total procedure time (min); Feasibility Endpoint - dose of contrast medium (ml); Feasibility Endpoint - dose of x-ray (cGy.cm2); Feasibility Endpoint - number of device implantation attempt during the procedure (number); Feasibility Endpoint - number of device change during the procedure (number); Net Clinical Benefit Endpoint; LAA patency; Device related thrombus

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: 28 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