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Cerebral Protection in Transcatheter Left Atrial Appendage Occlusion

NCT05369195 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2023-09-28

No results posted yet for this study

Summary

The study aims to assess the effect of the use of neuroprotection in transcutaneous occlusion of the left atrial appendage in patients with atrial fibrillation on the risk of perioperative silent brain ischemia and associated cognitive impairment and depression.

Conditions

Interventions

PROCEDURE

LAAC procedure with the use of transcatheter cerebral protection system

After aortography the cerebral protection system will be delivered to cerebral arteries through radial access before accessing the left atrium.

PROCEDURE

LAAC procedure without the use of transcatheter cerebral protection system

Only the aortography through radial access will be done before accessing the left atrium.

Sponsors & Collaborators

  • Leszek Giec Upper-Silesian Medical Centre

    collaborator UNKNOWN

  • Medical University of Silesia

    collaborator OTHER

  • Biostat Sp. z o.o.

    collaborator UNKNOWN

  • Silesian Centre for Heart Diseases

    lead OTHER

Principal Investigators

  • Zbigniew F Kalarus, Prof. · Silesian Centre for Heart Diseases in Zabrze

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-26
Primary Completion
2025-12-31
Completion
2026-09-30

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

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 NCT05369195 on ClinicalTrials.gov