Left atrial appendage closure for Atrial Fibrillation

N/A

Waitlist Available

Led By Ole De Backer, MD, PhD

Research Sponsored by Rigshospitalet, Denmark

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up periprocedural and between randomization and within 7 days of the procedure

Awards & highlights

Study Summary

This trial will assess whether the use of a computer simulation can help improve the outcome of a percutaneous left atrial appendage closure procedure.

Eligible Conditions

Atrial Fibrillation
Stroke Prevention

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ periprocedural and between randomization and within 7 days of the procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~periprocedural and between randomization and within 7 days of the procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and periprocedural and between randomization and within 7 days of the procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incomplete LAA closure and definite device-related thrombosis (DRT)

Secondary outcome measures

Composite of all-cause death and thromboembolic event

Contrast medium

Different degrees of contrast leakage into the LAA

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Computational simulation armExperimental Treatment2 Interventions

When patients are randomized to the computational simulation arm, the procedure will still be performed according to the participating site's routine practice - however, the procedure will only be performed after careful review of the FEops HEARTguideTM simulation results. The only prerequisite is that all patients randomized to this arm will have to undergo a pre-procedural cardiac CT-scan that will be uploaded into the FEops HEARTguideTM platform. Following this upload, a pre-procedural simulation plan will be provided to the operator, containing a set of optimal and suboptimal closure device sizes and implant positions. Software and technology upgrades of the FEops HEARTguideTM platform will be allowed during the course of the study.

Group II: Standard of care treatment armActive Control1 Intervention

When patients are randomized to the standard treatment arm, patients will be treated according to the participating site's routine practice. As pre-procedural imaging, a cardiac CT-scan has to be performed; this can also be complemented with TEE at the discretion of the operator. The LAA closure procedure should be performed according to routine practice of the participating site - either in general or local anesthesia. For those cases randomized to the standard treatment arm, the pre-procedural CT-scans will still be collected at completion of the study and FEops HEARTguideTM simulations will be generated, blinded for the procedural images and outcome. These simulations will be compared with the final device size and implant position and will be used for an additional comparative PREDICT-LAA sub-study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Left atrial appendage closure

2020

Completed Phase 4

~620

Do I qualify?Apply below to find out