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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03503253
Recruitment Status : Recruiting
First Posted : April 19, 2018
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Andrea Natale, 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.

Condition or disease Intervention/treatment Phase
Left Atrial Appendage Incomplete Closure Device: Interlock-35 Fibered IDC Occlusion System ; Device: Concerto Helix Detachable Coil System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Transcatheter Leak Closure With Detachable Coils Following Incomplete Left Atrial Appendage Closure Procedures
Actual Study Start Date : April 9, 2018
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2022

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. 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).

  3. 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).


Secondary Outcome Measures :
  1. Composite of all-cause mortality, stroke and bleeding [ Time Frame: 12 months ]
    Composite: stroke or transient ischemic attack, systemic embolism, major bleeding event.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03503253


Contacts
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Contact: Andrea Natale 5127842651 andrea.natale@stdavids.com
Contact: Domenico G Della Rocca 512-544-8198 domenico.dellarocca2@stdavids.com

Locations
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United States, Texas
Texas Cardiac Arrhythmia Institute Recruiting
Austin, Texas, United States, 78705
Contact: Andrea Natale    512-784-2651    andrea.natale@stdavids.com   
Sponsors and Collaborators
Texas Cardiac Arrhythmia Research Foundation
Investigators
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Principal Investigator: Andrea Natale Texas Cardiac Arrhythmia Research Foundation
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Andrea Natale, Executive Medical Director, Texas Cardiac Arrhythmia Research Foundation
ClinicalTrials.gov Identifier: NCT03503253    
Other Study ID Numbers: TCAI_Leak closure
First Posted: April 19, 2018    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: No plan yet

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes