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

  • STATUS
    Recruiting
  • End date
    May 14, 2022
  • participants needed
    120
  • sponsor
    Texas Cardiac Arrhythmia Research Foundation
Updated on 14 April 2021

Summary

Although the clinical impact of left atrial appendage (LAA) leaks still requires confirmation, the open pouch with residual flow resulting from incomplete LAA closure may promote blood stagnation and thrombus formation, and increase the risk of thromboembolic events. The main purpose of this trial is to evaluate the safety and efficacy of percutaneous leak closure with detachable vascular coils.

Description

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.

Details
Condition Left Atrial Appendage Incomplete Closure
Treatment Interlock-35 Fibered IDC Occlusion System ;, Concerto Helix Detachable Coil System, Interlock-35 Fibered IDC Occlusion System, Azur Peripheral Coil System
Clinical Study IdentifierNCT03503253
SponsorTexas Cardiac Arrhythmia Research Foundation
Last Modified on14 April 2021

Eligibility

Yes No Not Sure

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
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