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
Recruiting
- Conditions
- Atrial fibrillation and atrial flutter, unspecifiedI48.9
- Registration Number
- DRKS00023464
- Lead Sponsor
- Katholisches Krankenhaus St. Johan Nepomuk Erfurt
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the study should determine how often the LAAC procedure has to be changed due to information from the TEE; the efficacy endpoint is defined as the frequency of interruption of the LAAC by TEE
- Secondary Outcome Measures
Name Time Method