Peri-device Leakage Closure After LAAO

NCT ID: NCT04590898

Last Updated: 2022-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

85 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-27

Study Completion Date

2021-09-01

Brief Summary

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The investigators thought to evaluate the safety and feasibility of peri-device leakage closure after left atrial appendage occlusion (LAAO, either surgical or interventional) with different devices.

Detailed Description

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The global burden of atrial fibrillation (AF) is high and thromboembolic stroke may be one of the fatal complications. Oral anticoagulation has been the mainstay therapy for decades to mitigate stroke risk. However, in poor candidates for long-term anticoagulation non-pharmacological stroke prevention with percutaneous left atrial appendage occlusion (LAAO) is a considerable treatment option. LAA shape and size varies widely and incomplete LAA closure or new leaks, due to LAA remodeling after the procedure, are observed in up to 30% of patients. Those leaks may cause turbulent flow and increase the risk for thrombus formation and subsequent thromboembolic events. However, the clinical significance after percutaneous LAAO has yet to be determined.

If significant leaks are present, patients usually remain on oral anticoagulation. In very few cases, an interventional approach is used to close peri-device leaks.

This is the first systematic study, trying to include a respectable number of patients who underwent peri-device leakage closure after LAAO. In this multi-center, collaborative study the investigators aim to identify different peri-device leak closure strategies with associated clinical outcomes and evaluate safety and feasibility of the procedure.

Conditions

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Atrial Fibrillation Stroke Bleeding Leakage of Cardiac Device

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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significant peri-device leakage after LAA occlusion

Peri-device leakage closure after left atrial appendage occlusion

Peri-device leakage closure after left atrial appendage occlusion

Intervention Type DEVICE

Peri-device leakage closure after left atrial appendage occlusion

Interventions

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Peri-device leakage closure after left atrial appendage occlusion

Peri-device leakage closure after left atrial appendage occlusion

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients after interventional or surgical left atrial appendage occlusion with severe leakage, who underwent interventional peri-device leakage closure

Exclusion Criteria

* n/a
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cardiovascular Center Frankfurt

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kerstin Piayda

Role: STUDY_CHAIR

University Hospital Düsseldorf and Cardio Vascular Center Frankfurt

Locations

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• Banner University Medical Center Phoenix

Phoenix, Arizona, United States

Site Status

Scripps Health

La Jolla, California, United States

Site Status

Kansas City Heart Rhythm Institute

Overland Park, Kansas, United States

Site Status

Mayo Clinic Hospital - Saint Mary's Campus

Rochester, Minnesota, United States

Site Status

Vanderbilt Heart Institute

Nashville, Tennessee, United States

Site Status

Austin Heart

Austin, Texas, United States

Site Status

University of Utah Hospital

Salt Lake City, Utah, United States

Site Status

Aarhus University Hospital

Aarhus, , Denmark

Site Status

Rigshospitalet Copenhagen

Copenhagen, , Denmark

Site Status

Cardio Vascular Center Frankfurt

Frankfurt am Main, Hesse, Germany

Site Status

Universitätsklinikum Düsseldorf

Düsseldorf, North Rhine-Westphalia, Germany

Site Status

Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)

Berlin, , Germany

Site Status

Poznan University of Medical Sciences

Poznan, , Poland

Site Status

Hospital Universitario de Salamanca

Salamanca, , Spain

Site Status

Inselspital Bern

Bern, , Switzerland

Site Status

Nuffield Health

Headington, , United Kingdom

Site Status

Countries

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United States Denmark Germany Poland Spain Switzerland United Kingdom

Other Identifiers

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CVC-002

Identifier Type: -

Identifier Source: org_study_id

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