DRKS00023464RecruitingNot Applicable
FLUORoscopy-Only based interventional closure of the left atrial appendage using the WATCHMAN FLX in patients with atrial fibrillation and contraindication against oral anticoagulation – feasibility and safety - Fluoro-FLX
Katholisches Krankenhaus St. Johan Nepomuk Erfurt0 sites30 target enrollmentStarted: December 11, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 Years to one (—)
- Sex
- All
Inclusion Criteria
- •age >18 Jahre
- •atrial fibrillation (paroxysmal, persistent, or permanent) with a scheduled interventional closure of the left atrial appendage
- •signed informed consent
- •exclusion of intracardiac thrombi by cardiac CT within 72 hours before the LAAC
- •no long-term interruption of oral anticoagulation before the LAAC (last dose of NOAC or low molecular weight heparin within 36 h before LAAC)
Exclusion Criteria
- •history of open heart surgery
- •unsuitable anatomy for LAAC due to cardiac CT
- •history of ASD/ PFO closure
- •contraindication regarding TEE
- •lack of informed consent
- •impossibility to perform follow-up TEE after 3 months
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