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

Not Applicable

• Conditions: Left Atrial Appendage Incomplete Closure
• Interventions: Device: Interlock-35 Fibered IDC Occlusion System; Device: Concerto Helix Detachable Coil System; Device: Azur Peripheral Coil System

• Registration Number: NCT03503253
• Lead Sponsor: Texas Cardiac Arrhythmia Research Foundation

Brief 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.

Study Timeline

• Study Start: 2018-04-09
• Study First Submitted: 2018-04-11
• Study First Submitted QC: 2018-04-18
• Study First Posted: 2018-04-19
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-03
• Last Update Posted: 2021-04-06
• Primary Completion: 2021-05
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single-arm	Azur Peripheral Coil System	LAA leak closure using detachable coils; Interlock-35 Fibered IDC Occlusion System, Concerto Helix Detachable Coil System
Single-arm	Interlock-35 Fibered IDC Occlusion System	LAA leak closure using detachable coils; Interlock-35 Fibered IDC Occlusion System, Concerto Helix Detachable Coil System
Single-arm	Concerto Helix Detachable Coil System	LAA leak closure using detachable coils; Interlock-35 Fibered IDC Occlusion System, Concerto Helix Detachable Coil System

Primary Outcome Measures

Name	Time	Method
Procedural success	7 days	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.
Incidence of Major Adverse Events (MAE)	30 days	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).
Rate of LAA leak closure	60 days	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).

Secondary Outcome Measures

Name	Time	Method
Composite of all-cause mortality, stroke and bleeding	12 months	Composite: stroke or transient ischemic attack, systemic embolism, major bleeding event.

Trial Locations

Locations (1)

Texas Cardiac Arrhythmia Institute; 🇺🇸 Austin, Texas, United States