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

April 3, 2021 updated by: Andrea Natale, Texas Cardiac Arrhythmia Research Foundation
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single-arm
LAA leak closure using detachable coils; Interlock-35 Fibered IDC Occlusion System, Concerto Helix Detachable Coil System
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedural success
Time Frame: 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.
7 days
Rate of LAA leak closure
Time Frame: 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).
60 days
Incidence of Major Adverse Events (MAE)
Time Frame: 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).
30 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Texas Cardiac Arrhythmia Research Foundation

Investigators

  • Principal Investigator: Andrea Natale, Texas Cardiac Arrhythmia Research Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2018

Primary Completion (Anticipated)

May 1, 2021

Study Completion (Anticipated)

May 1, 2022

Study Registration Dates

First Submitted

April 11, 2018

First Submitted That Met QC Criteria

April 18, 2018

First Posted (Actual)

April 19, 2018

Study Record Updates

Last Update Posted (Actual)

April 6, 2021

Last Update Submitted That Met QC Criteria

April 3, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • TCAI_Leak closure

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

No plan yet

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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