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

T

Texas Cardiac Arrhythmia Research Foundation

Status

Unknown

Conditions

Left Atrial Appendage Incomplete Closure

Treatments

Device: Azur Peripheral Coil System
Device: Concerto Helix Detachable Coil System
Device: Interlock-35 Fibered IDC Occlusion System

Study type

Interventional

Funder types

Other

Identifiers

NCT03503253
TCAI_Leak closure

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

120 participants in 1 patient group

Single-arm
Other group
Description:
LAA leak closure using detachable coils; Interlock-35 Fibered IDC Occlusion System, Concerto Helix Detachable Coil System
Treatment:
Device: Interlock-35 Fibered IDC Occlusion System
Device: Concerto Helix Detachable Coil System
Device: Azur Peripheral Coil System

Trial contacts and locations

1

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Central trial contact

Andrea Natale; Domenico G Della Rocca

Data sourced from clinicaltrials.gov

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