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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Left Atrial Appendage Incomplete Closure

Intervention / Treatment
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* Device: Interlock-35 Fibered IDC Occlusion System
* Device: Concerto Helix Detachable Coil System
* Device: Azur Peripheral Coil System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, single arm study with consecutive, eligible subject enrollment. All subjects will undergo percutaneous LAA leak closure procedure with detachable coils.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single-arm<br>LAA leak closure using detachable coils; Interlock-35 Fibered IDC Occlusion System, Concerto Helix Detachable Coil System | Device: Interlock-35 Fibered IDC Occlusion System<br>* Use of detachable coil for LAA leak closure<br>Device: Concerto Helix Detachable Coil System<br>* Use of detachable coil for LAA leak closure<br>Device: Azur Peripheral Coil System<br>* Use of detachable coil for LAA leak closure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success | Procedural success, defined as successful delivery, deployment release of detachable coil(s) into the LAA, and incidence of LAA occlusion as measured by fluoroscopy and echocardiographic color Doppler jets less than 3mm by TEE at the end of the procedure. | 7 days | 
| Rate of LAA leak closure | LAA occlusion will be assessed by TEE color Doppler and will be defined as absence of flow in the LAA or minimal color Doppler jets (< 1mm). | 60 days | 
| Incidence of Major Adverse Events (MAE) | Rate of procedure- and device-related complications (device embolization; cardiac injury, re-intervention, and/or device-related surgery; bleeding events such as pericardial effusion requiring drainage, cranial bleeding due to any source, gastrointestinal bleeding; transient ischemic attack/stroke; systemic embolism; death; or any other event related to the device or the procedure, which requires treatment). | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of all-cause mortality, stroke and bleeding | Composite: stroke or transient ischemic attack, systemic embolism, major bleeding event. | 12 months |