NCT03503253

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Texas Cardiac Arrhythmia Research Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Left Atrial Appendage Incomplete Closure

Interventions

Type	Name	Description
DEVICE	Interlock-35 Fibered IDC Occlusion System	Use of detachable coil for LAA leak closure
DEVICE	Concerto Helix Detachable Coil System	Use of detachable coil for LAA leak closure
DEVICE	Azur Peripheral Coil System	Use of detachable coil for LAA leak closure

Timeline

• Start date: 2018-04-09
• Primary completion: 2021-05-01
• Completion: 2022-05-01
• First posted: 2018-04-19
• Last updated: 2021-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study