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

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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

Tracking Information
First Submitted Date  ICMJE April 11, 2018
First Posted Date  ICMJE April 19, 2018
Last Update Posted Date March 14, 2019
Actual Study Start Date  ICMJE April 9, 2018
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2018)
  • 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.
  • 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).
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2018)
Composite of all-cause mortality, stroke and bleeding [ Time Frame: 12 months ]
Composite: stroke or transient ischemic attack, systemic embolism, major bleeding event.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transcatheter Leak Closure With Detachable Coils Following Incomplete Left Atrial Appendage Closure Procedures
Official Title  ICMJE Transcatheter Leak Closure With Detachable Coils Following Incomplete Left Atrial Appendage Closure Procedures
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Left Atrial Appendage Incomplete Closure
Intervention  ICMJE
  • 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
Study Arms  ICMJE Single-arm
LAA leak closure using detachable coils; Interlock-35 Fibered IDC Occlusion System, Concerto Helix Detachable Coil System
Interventions:
  • Device: Interlock-35 Fibered IDC Occlusion System ;
  • Device: Concerto Helix Detachable Coil System
Publications * Della Rocca DG, Horton RP, Di Biase L, Bassiouny M, Al-Ahmad A, Mohanty S, Gasperetti A, Natale VN, Trivedi C, Gianni C, Burkhardt JD, Gallinghouse GJ, Hranitzky P, Sanchez JE, Natale A. First Experience of Transcatheter Leak Occlusion With Detachable Coils Following Left Atrial Appendage Closure. JACC Cardiovasc Interv. 2020 Feb 10;13(3):306-319. doi: 10.1016/j.jcin.2019.10.022. Epub 2020 Jan 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 18, 2018)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2022
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Andrea Natale 5127842651 andrea.natale@stdavids.com
Contact: Domenico G Della Rocca 512-544-8198 domenico.dellarocca2@stdavids.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03503253
Other Study ID Numbers  ICMJE TCAI_Leak closure
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: No plan yet
Responsible Party Andrea Natale, Texas Cardiac Arrhythmia Research Foundation
Study Sponsor  ICMJE Texas Cardiac Arrhythmia Research Foundation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrea Natale Texas Cardiac Arrhythmia Research Foundation
PRS Account Texas Cardiac Arrhythmia Research Foundation
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP