APPEND-CT Registry

NCT ID: NCT06213285

Last Updated: 2024-05-30

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

ENROLLING_BY_INVITATION

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-14

Study Completion Date

2025-01-31

Brief Summary

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The APPEND-CT registry is an investigator-driven multicenter retrospective observational database intended to compile cardiac CT follow-up data after Watchman FLX device implantation and function as a platform for answering clinical and research questions within LAAC follow-up. The derived studies should support therapeutic decision-making, improve risk-stratification in LAAC and help generate hypotheses for potential future clinical intervention trials.

Detailed Description

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An investigator-driven multicenter retrospective observational database enrolling patients from high-volume North American and European centers. The database will include Watchman FLX implanted patients with a minimum of one follow-up cardiac CT performed within 45-120 days post-procedure. Additional timepoints may be entered. Cardiac CT scans are to be uploaded and will be analyzed by the core-lab at Aarhus University Hospital.

Investigator-reported findings will be systematically reported to the database. This includes information on baseline characteristics, preprocedural planning, implantation details, discharge medication, follow-up imaging and clinical endpoints of interest.

As a minimum, investigator-reported endpoints will be collected from patient registries at one-year follow-up by site-investigators. Endpoints of interest include ischemic stroke, systemic embolism, major bleeding, mortality, device-related thrombosis, pericardial effusion, vascular complications, and device migration.

Conditions

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Stroke, Ischemic Device Related Thrombosis Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Watchman FLX left atrial appendage occlusion

Early (30-120 days) CT follow-up after Watchman FLX LAAO

Intervention Type DEVICE

Other Intervention Names

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left atrial appendage closure LAAO LAAC

Eligibility Criteria

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Inclusion Criteria

* Watchman FLX LAAO
* A minimum of one follow-up cardiac CT performed within 30-120 days post-procedure.
* A minimum of one year clinical follow-up data
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role collaborator

Boston Scientific Corporation

INDUSTRY

Sponsor Role collaborator

Aarhus University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Anders Kramer

MD, PhD-fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anders Kramer, MD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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United States Denmark

Other Identifiers

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ISRCAR00442

Identifier Type: -

Identifier Source: org_study_id

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