Transcatheter Leak Closure With Detachable Coils Following Incomplete Left Atrial Appendage Closure Procedures

Therapies locally targeting the LAA via occlusion, exclusion, or excision have emerged as an
alternative and effective approach for stroke prophylaxis in AF patients, especially those
with OAC contra-indications. Despite mounting evidence of their safety and efficacy in
comparison with standard oral therapy, device-related thrombus and incomplete LAA closure
resulting in residual, significant leak may occur, potentially hindering an effective stroke
prevention. To date, detachable coils have found a wide range of applications for
transcatheter occlusion/embolization procedures (e.g., cerebral aneurysms, pulmonary, renal
and cerebral arteriovenous malformations, patent ductus arteriosus, endoleaks). The main
purpose of this trial is to evaluate the feasibility and efficacy of transcatheter leak
closure with detachable coils in patients with evidence of incomplete percutaneous/epicardial
LAA exclusion.

Inclusion Criteria:

- Age> 18 years.

- Presence of a significant LAA leak (moderate/severe following percutaneous occlusions
or mild/severe after epicardial exclusions with the LARIAT suture delivery device).

- Less moderate embolic risk (CHA2DS2-VASc ≥2)

- High associated hemorrhagic risk (HASBLED ≥ 3), or absolute contraindication to OAC,
or need for prolonged dual antiplatelet therapy, or history of thromboembolic events
despite LAA occlusion/exclusion after other potential causes.

- written informed consent obtained from subject or subject's legal representative and
ability for subject to comply with the requirements of the study

Exclusion Criteria:

- Life expectancy < 2 years.

- pregnant, breastfeeding, or unwilling to practice birth control during participation
in the study

- presence of a condition or abnormality that in the opinion of the Investigator would
compromise the safety of the patient or the quality of the data