NCT05014477

Brief Summary

The investigators thought to evaluate risk factors, therapeutic approaches and outcomes after left atrial appendage occluder device embolization (LAAO, either surgical or interventional).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 20, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

July 26, 2022

Status Verified

July 1, 2022

Enrollment Period

1 year

First QC Date

August 12, 2021

Last Update Submit

July 22, 2022

Conditions

Left Atrial Appendage OccluderDevice EmbolisationTherapy StrategiesRisk Factors

Keywords

left atrial appendage occluderdevice embolizationtherapy strategyrisk factors

Outcome Measures

Primary Outcomes (3)

  • Procedural mortality

    all-cause mortality during the index procedure, any procedure-related death within 30days or during in-hospital stay for the index procedure (if\>30days)

    In-hospital stay, assessed up to 30 days

  • Need for cardiac surgery

    In-hospital stay, assessed up to 30 days

  • Catheter-based retrieval of LAA Occluder

    peri-procedural device removal

    up to 5 years (after device implantation)

Secondary Outcomes (2)

  • Further complications

    up to 5 years (after device implantation)

  • Risk factors

    up to 30 days (after device implantation)

Study Arms (1)

Patients experiencing device embolization after left atrial appendage occlusion

Device embolization following either surgical or interventional left atrial appendage occlusion

Procedure: Removal or leaving of LAA occluders

Interventions

Removal or leaving of LAA occludersPROCEDURE

After LAA device embolization there are different approaches to dealing with the occluder dislocation. The aim is to find out which way leads to the best outcomes.

Patients experiencing device embolization after left atrial appendage occlusion

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients after interventional or surgical left atrial appendage occlusion with device embolization

You may qualify if:

  • Patients after interventional or surgical left atrial appendage occlusion with device embolization

You may not qualify if:

  • n/a

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CardioVascular Center (CVC) Frankfurt

Frankfurt on the Main, Hesse, 60389, Germany

Location

Study Officials

  • Sophie Eppinger

    CardioVascular Center (CVC) Frankfurt, Seckbacher Landstraße 65, 60389 Frankfurt am Main, Hesse, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

August 12, 2021

First Posted

August 20, 2021

Study Start

September 30, 2020

Primary Completion

September 30, 2021

Study Completion

December 31, 2023

Last Updated

July 26, 2022

Record last verified: 2022-07

Locations

DE(1)