NCT05369195

Brief 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
4mo left

Started May 2023

Typical duration for not_applicable atrial-fibrillation

Geographic Reach
1 country

6 active sites

Status
recruiting

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 Progress90%
May 2023Sep 2026

First Submitted

Initial submission to the registry

March 15, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 11, 2022

Completed
1 year until next milestone

Study Start

First participant enrolled

May 26, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

September 28, 2023

Status Verified

March 1, 2023

Enrollment Period

2.6 years

First QC Date

March 15, 2022

Last Update Submit

September 26, 2023

Conditions

Atrial FibrillationSilent StrokeCognitive ImpairmentDepression

Keywords

cerebral protectionleft atrial appendage occlusionatrial fibrillationsilent brain ischemiacognitive impairmentdepression

Outcome Measures

Primary Outcomes (2)

  • Change in number of silent cerebral ischemia (SBI) foci

    number of SBI foci in DW MRI of the brain

    change in the period up to 24 months

  • Change in volume of silent cerebral ischemia (SBI) foci

    volume SBI foci in DW MRI of the brain

    change in the period up to 24 months

Secondary Outcomes (5)

  • Deterioration of cognitive functions

    prior to procedure, discharge (up to 5 days), 90 days, 12 months, 24 months

  • Deterioration of cognitive functions

    prior to procedure, discharge (up to 5 days), 90 days, 12 months, 24 months

  • Development of dementia

    prior to procedure, discharge (up to 5 days), 90 days, 12 months, 24 months

  • Occurrence of depressive disorders

    prior to procedure, discharge (up to 5 days), 90 days, 12 months, 24 months

  • Presence of embolic material in the filters of the neuroprotection device

    during LAAC procedure

Study Arms (2)

LAAC with neuroprotection

EXPERIMENTAL

Arm in which is used a transcatheter system to protect the cerebral circulation during the left atrial appendage closure procedures.

Procedure: LAAC procedure with the use of transcatheter cerebral protection system

LAAC without neuroprotection

PLACEBO COMPARATOR

Arm in which the left atrial appendage closure procedures are performed without transcatheter cerebral protection.

Procedure: LAAC procedure without the use of transcatheter cerebral protection system

Interventions

LAAC procedure with the use of transcatheter cerebral protection systemPROCEDURE

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

LAAC with neuroprotection
LAAC procedure without the use of transcatheter cerebral protection systemPROCEDURE

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

LAAC without neuroprotection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Years and older
  • Subject able to provide signed informed consent.
  • Documented permanent, persistent, or paroxysmal atrial fibrillation
  • CHA2DS2VASc risk of stroke ≥2
  • At least one of the following criteria:
  • Contraindications to the use of anticoagulants,
  • HSBLED bleeding risk ≥3

You may not qualify if:

  • Serious mental diseases, particularly: dementia syndrome of any etiology, schizophrenia,schizoaffective disorders, bipolar disorder
  • History of ischemic stroke
  • Chronic abuse of alcohol or any other psychoactive substances except for nicotine
  • long-term therapy with benzodiazepines
  • Previous infections of the central nervous system, including neuroborreliosis
  • Parkinson's disease
  • Huntington's chorea
  • Creutzfeld-Jakob disease
  • Pick's disease
  • Significant atherosclerosis of the cephalic arteries (\> 70% LCCA or the brachiocephalic trunk)
  • Strictures, ectasias, dissection or aneurysms at the exit of the LCCA or the brachiocephalic trunk from the aorta and up to 3 cm above
  • Advancement of vascular changes in DW MRI of the head, grade 3 on the Fazekas scale
  • Presence of a thrombus or tumours of a different nature in the left atrium or its ear
  • Presence of a thrombus in the left ventricle
  • Left atrial appendage anatomy preventing the use of occluders to close the left atrium appendage
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Górnośląskie Centrum Medyczne im. prof. Leszka Gieca Śląskiego Uniwesryeteu Medycznego

Katowice, 40-635, Poland

NOT YET RECRUITING

Klinika Chorób Serca i Naczyń, Krakowski Szpital Specjalistyczny im. Jana Pawła II

Krakow, 31-202, Poland

NOT YET RECRUITING

I Klinika Kardiologii Katedry Kardiologii UM im. Karola Marcinkowskiego w Poznaniu, Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu

Poznan, 61-848, Poland

NOT YET RECRUITING

Klinika Kardiologii i Chorób Wewnętrznych, Wojskowy Instytut Medyczny

Warsaw, 04-141, Poland

NOT YET RECRUITING

Klinika Choroby Wieńcowej i Strukturalnych Chorób Serca, Narodowy Instytut Kardiologii Stefana kardynała Wyszyńskiego - Państwowy Instytut Badawczy

Warsaw, 04-625, Poland

NOT YET RECRUITING

Silesian Centre for HEart Diseases in Zabrze

Zabrze, 41-800, Poland

RECRUITING

Related Publications (1)

  • Streb W, Lasek-Bal A, Mitrega K, Kowalczyk J, Podolecki T, Kowalska W, Olma A, Sobczyk A, Kalarus Z. Rationale and design of a randomized clinical trial evaluating the efficacy of mechanical neuroprotection in reducing the risk of silent brain infarcts associated with percutaneous left atrial appendage closure: study protocol for a LAAC-SBI trial. Trials. 2023 Nov 23;24(1):749. doi: 10.1186/s13063-023-07766-3.

    PMID: 37996955DERIVED

MeSH Terms

Conditions

Atrial FibrillationCognitive DysfunctionDepression

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Zbigniew F Kalarus, Prof.

    Silesian Centre for Heart Diseases in Zabrze

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Witold A Streb, Ph.D.

CONTACT

0048322713414w.streb@sccs.pl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
In order to blind the radial artery will also be punctured in control group and an aortography will be performed. Researchers participating in the randomization of patients and in the procedure will not be included in the remaining stages of the study.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2022

First Posted

May 11, 2022

Study Start

May 26, 2023

Primary Completion

December 31, 2025

Study Completion (Estimated)

September 1, 2026

Last Updated

September 28, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

PL(6)