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Compares treatment options for Intracranial Hemorrhages
Official title Comparison of LAA-Closure vs Oral Anticoagulation in Patients With NVAF and Status Post Intracranial Bleeding.
ClinicalTrials.gov ID: NCT04298723
What this study is testing
- What it's testing
- Atrial fibrillation is the most common cardiac arrhythmia. In atrial fibrillation, there is a risk that clots can form in the heart, especially in the left atrium.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed written informed consent
- Documented atrial fibrillation (paroxysmal, persistent, long-standing persistent or permanent)
- CHA2DS2VASc-Score ≥2
- Status post intracranial bleeding \>6 weeks
- Favorable LAA anatomy
You likely can't join if
- Comorbidities other than AF requiring chronic (N)OAC therapy, e.g. mechanical heart valve prosthesis, hereditary thrombophilia requiring livelong OAC...
- Symptomatic carotid disease (if not treated)
- Thrombus in the left atrium or left atrial appendage
- Active infection or active endocarditis or other infections resulting in bacteremia
- Functional Impairment (modified ranking scale ≥4 )
- Severe liver failure (Child-Pugh class C or liver failure with coagulopathy)
See the full eligibility criteria
- Signed written informed consent
- Documented atrial fibrillation (paroxysmal, persistent, long-standing persistent or permanent)
- CHA2DS2VASc-Score ≥2
- Status post intracranial bleeding \>6 weeks
- Favorable LAA anatomy
- Subject eligible for a LAA occluder device
- Age ≥18 years
- Comorbidities other than AF requiring chronic (N)OAC therapy, e.g. mechanical heart valve prosthesis, hereditary thrombophilia requiring livelong OAC - recurrent thrombosis
- Symptomatic carotid disease (if not treated)
- Thrombus in the left atrium or left atrial appendage
- Active infection or active endocarditis or other infections resulting in bacteremia
- Functional Impairment (modified ranking scale ≥4 )
- Severe liver failure (Child-Pugh class C or liver failure with coagulopathy)
- Pregnancy or breastfeeding
- Subject with participation in another treatment clinical trial during this study or within 30 days before entry into this trial.
- Known terminating disease with life expectancy \<1 year (including those with end-stage heart failure)
- people, who are committed to an institution due to binding official or court order
- people with planned cardiac or non-cardiac surgery or intervention. (These people can be included 30 days after intervention / surgery
The study team makes the final eligibility decision.
Where it's taking place
- Mannheim, Baden-Wurttemberg, Germany
- Bad Neustadt an der Saale, Bavaria, Germany
- Burgau, Bavaria, Germany
- Coburg, Bavaria, Germany
- Erlangen, Bavaria, Germany
- Ingolstadt, Bavaria, Germany
- Rosenheim, Bavaria, Germany
- Hamburg, Free and Hanseatic City of Hamburg, Germany
- Rotenburg an der Fulda, Hesse, Germany
- Bielefeld, North Rhine-Westphalia, Germany
- Dortmund, North Rhine-Westphalia, Germany
- Kaiserslautern, Rhineland-Palatinate, Germany
- Koblenz, Rhineland-Palatinate, Germany
- Chemnitz, Saxony, Germany
- Dresden, Saxony, Germany
- Leipzig, Saxony, Germany
- Pirna, Saxony, Germany
- Zwickau, Saxony, Germany
- Magdeburg, Saxony-Anhalt, Germany
- Lübeck, Schleswig-Holstein, Germany
+ 6 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mannheim, Baden-Wurttemberg, Germany; Bad Neustadt an der Saale, Bavaria, Germany; Burgau, Bavaria, Germany; Coburg, Bavaria, Germany; Erlangen, Bavaria, Germany; Ingolstadt, Bavaria, Germany and 20 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.