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

NCT03503253 | Unknown FDA Device

• 1 other identifier: TCAI_Leak closure
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Left Atrial Appendage Incomplete Closure

Outcome Measures

Primary Outcomes (3)

• Procedural success

  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

  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)

  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 Outcomes (1)

• Composite of all-cause mortality, stroke and bleeding

  12 months

Study Arms (1)

Single-arm

OTHER

LAA leak closure using detachable coils; Interlock-35 Fibered IDC Occlusion System, Concerto Helix Detachable Coil System

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

Interventions

Interlock-35 Fibered IDC Occlusion System DEVICE

Use of detachable coil for LAA leak closure

Single-arm

Concerto Helix Detachable Coil System DEVICE

Use of detachable coil for LAA leak closure

Single-arm

Azur Peripheral Coil System DEVICE

Use of detachable coil for LAA leak closure

Single-arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\> 18 years.
• Less moderate embolic risk (CHA2DS2-VASc ≥2)
• written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas Cardiac Arrhythmia Research Foundation: lead

Study Sites (1)

Texas Cardiac Arrhythmia Institute

Austin, Texas, 78705, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 31954677 DERIVED

Study Officials

• Andrea Natale

  Texas Cardiac Arrhythmia Research Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Natale

CONTACT

5127842651; andrea.natale@stdavids.com

Domenico G Della Rocca

CONTACT

512-544-8198; domenico.dellarocca2@stdavids.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Medical Director

Model Details: Prospective, single arm study with consecutive, eligible subject enrollment. All subjects will undergo percutaneous LAA leak closure procedure with detachable coils.

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: April 19, 2018
• Study Start: April 9, 2018
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2022
• Last Updated: April 6, 2021

Record last verified: 2021-04

Locations

US (1)