- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03503253
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
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
- Name: Andrea Natale
- Phone Number: 5127842651
- Email: andrea.natale@stdavids.com
Study Contact Backup
- Name: Domenico G Della Rocca
- Phone Number: 512-544-8198
- Email: domenico.dellarocca2@stdavids.com
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78705
- Recruiting
- Texas Cardiac Arrhythmia Institute
-
Contact:
- Andrea Natale
- Phone Number: 512-784-2651
- Email: andrea.natale@stdavids.com
-
-
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
|
Use of detachable coil for LAA leak closure
Use of detachable coil for LAA leak closure
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.
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.
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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