MedTrace Logo

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

NCT03503253 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-04-06

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Texas Cardiac Arrhythmia Research Foundation

    lead OTHER

Principal Investigators

  • Andrea Natale · Texas Cardiac Arrhythmia Research Foundation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-09
Primary Completion
2021-05-31
Completion
2022-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03503253 on ClinicalTrials.gov