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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00023464

Enrollment

Registered

2020-12-11

Start date

2020-10-25

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I48.9

Interventions

Group 1: in patients with atrial fibrillation and contraindication regarding oral anticoagulation for which an interventional closure of the left atrial appendage (LAAC) has been planned, the LAAC is

an transesophageal echocardiography (TEE) is performed by a second physician to ensure patient safety but the TEE images are not available to the implanting physician

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
/not defined	—

Countries

Germany

Contacts

Public ContactHenning Ebelt

Katholisches Krankenhaus Erfurt

hebelt@kkh-erfurt.de+49-361-6541111

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026