Cerebral Protection in Transcatheter Left Atrial Appendage Occlusion (LAAC-SBI)

September 26, 2023 updated by: Silesian Centre for Heart Diseases

Cerebral Protection in Transcatheter Left Atrial Appendage Occlusion in Patients With Atrial Fibrillation

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Introduction: Left atrial appendage occlusion (LAAC) procedure is a method of preventing stroke in patients with atrial fibrillation who cannot use anticoagulants. The number of patients undergoing LAAC treatment tends to increase. LAAC procedures effectively reduce the number of strokes, with a significant reduction in the risk of bleeding compared to oral anticoagulants. However, although LAAC treatments alone have a low risk of perioperative stroke, some patients may experience incidents of silent brain ischemia (SBI). The distant effect of SBI may be cognitive deterioration, the onset of dementia syndromes, as well as depression.

Purpose of the study: The study aims to assess the effect of the use of neuroprotection in transcutaneous occlusion of the left atrial appendage (LAAC) in patients with atrial fibrillation on the risk of perioperative SBI and associated cognitive impairment and depression.

Methodology: The planned study is a prospective, multicentre, randomized, and double-blind intervention trial. Neuroprotection introduced from arterial access will be used in the LAAC treatment study group. In the control group, LAAC treatments will be performed without neuroprotection. Two hundred forty patients are planned to be enrolled with indications for stroke prevention due to atrial fibrillation. The analysis will include data obtained from DW MRI images, neurological evaluation results along with NIHSS-scale scores, results of cognitive evaluation tests (MoCA, COWAT, TMT A&B), and test of mood disorders (HADS Scale), as well as results of the EQ-5D-5L quality of life assessment questionnaire. It is planned to observe patients participating in the study for 24 months after LAAC procedure.

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Witold A Streb, Ph.D.
  • Phone Number: 0048322713414
  • Email: w.streb@sccs.pl

Study Locations

  • Poland
      • Katowice, Poland, 40-635
        • Not yet recruiting
        • Górnośląskie Centrum Medyczne im. prof. Leszka Gieca Śląskiego Uniwesryeteu Medycznego
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wojciech Wojakowski, Prof.
      • Kraków, Poland, 31-202
        • Not yet recruiting
        • Klinika Chorób Serca i Naczyń, Krakowski Szpital Specjalistyczny im. Jana Pawła II
        • Contact:
        • Principal Investigator:
          • Tadeusz Przewłocki, Prof.
      • Poznań, Poland, 61-848
        • Not yet recruiting
        • I Klinika Kardiologii Katedry Kardiologii UM im. Karola Marcinkowskiego w Poznaniu, Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu
        • Contact:
        • Principal Investigator:
          • Marek Grygier
      • Warszawa, Poland, 04-141
        • Not yet recruiting
        • Klinika Kardiologii i Chorób Wewnętrznych, Wojskowy Instytut Medyczny
        • Contact:
        • Principal Investigator:
          • Piotr Kwiatkowski, MD
      • Warszawa, Poland, 04-625
        • Not yet recruiting
        • Klinika Choroby Wieńcowej i Strukturalnych Chorób Serca, Narodowy Instytut Kardiologii Stefana kardynała Wyszyńskiego - Państwowy Instytut Badawczy
        • Contact:
        • Principal Investigator:
          • Marcin Demkow, Prof.
      • Zabrze, Poland, 41-800
        • Recruiting
        • Silesian Centre for HEart Diseases in Zabrze
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zbigniew Kalarus, Prof
        • Sub-Investigator:
          • Witold Streb, Ph.D
        • Sub-Investigator:
          • Katarzyna Mitręga, MD
        • Sub-Investigator:
          • Wiktoria Kowalska, MD
        • Sub-Investigator:
          • Monika Kozioł, MD
        • Sub-Investigator:
          • Tomasz Podolecki, Ph.D.
        • Sub-Investigator:
          • Agata Sobczyk, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 18 Years and older
  2. Subject able to provide signed informed consent.
  3. Documented permanent, persistent, or paroxysmal atrial fibrillation
  4. CHA2DS2VASc risk of stroke ≥2

  5. At least one of the following criteria:

    1. Contraindications to the use of anticoagulants,
    2. HSBLED bleeding risk ≥3

Exclusion Criteria:

  1. Serious mental diseases, particularly: dementia syndrome of any etiology, schizophrenia,schizoaffective disorders, bipolar disorder
  2. History of ischemic stroke
  3. Chronic abuse of alcohol or any other psychoactive substances except for nicotine
  4. long-term therapy with benzodiazepines
  5. The use of antidepressants in 3 months prior inclusion.
  6. Previous infections of the central nervous system, including neuroborreliosis
  7. Parkinson's disease
  8. Huntington's chorea
  9. Creutzfeld-Jakob disease
  10. Pick's disease
  11. Significant atherosclerosis of the cephalic arteries (> 70% LCCA or the brachiocephalic trunk)
  12. Strictures, ectasias, dissection or aneurysms at the exit of the LCCA or the brachiocephalic trunk from the aorta and up to 3 cm above
  13. Advancement of vascular changes in DW MRI of the head, grade 3 on the Fazekas scale
  14. Presence of a thrombus or tumours of a different nature in the left atrium or its ear
  15. Presence of a thrombus in the left ventricle
  16. Left atrial appendage anatomy preventing the use of occluders to close the left atrium appendage
  17. The presence of mechanical heart valve prostheses
  18. The state after the operative closure of the defect in the atrial septum
  19. Condition after closing the defect in the interatrial septum with the use of occluders
  20. Active infective endocarditis
  21. Presence of devices and prostheses that prevent the performance of MRI (pacemakers, clips in the CNS)
  22. Status after oesophagal surgery
  23. Esophageal diverticula
  24. Esophageal varices> grade 3
  25. Allergic to contrast agents
  26. A contraindication to use antiplatelet drugs
  27. Diagnosis of neoplastic disease with estimated survival beyond 1 year
  28. Clininally evident hypothyroidism and hyperthyroidism
  29. Klaustrofobia
  30. Pregnancy
  31. AIDS
  32. Participation in other drug research studies
  33. The presence of circumstances or any medical condition the Investigator considers problematic for subject inclusion, or test results that may couse problems to provide reliable, acurate to interpretation results

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LAAC with neuroprotection
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
After aortography the cerebral protection system will be delivered to cerebral arteries through radial access before accessing the left atrium.
Placebo Comparator: LAAC without neuroprotection
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
Only the aortography through radial access will be done before accessing the left atrium.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in number of silent cerebral ischemia (SBI) foci
Time Frame: change in the period up to 24 months
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
Time Frame: change in the period up to 24 months
volume SBI foci in DW MRI of the brain
change in the period up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Deterioration of cognitive functions
Time Frame: prior to procedure, discharge (up to 5 days), 90 days, 12 months, 24 months
Montreal Cognitive Assessment (MoCA) test (scoring 0-30; cut-off value <26)
prior to procedure, discharge (up to 5 days), 90 days, 12 months, 24 months
Deterioration of cognitive functions
Time Frame: prior to procedure, discharge (up to 5 days), 90 days, 12 months, 24 months
The Trail Making Test Part A and B for Dementia (TMT A&B) - incorrect values: for part A > 70 sec. and for part B> 273 sec.
prior to procedure, discharge (up to 5 days), 90 days, 12 months, 24 months
Development of dementia
Time Frame: prior to procedure, discharge (up to 5 days), 90 days, 12 months, 24 months
diagnosis made by a specialist neurologist
prior to procedure, discharge (up to 5 days), 90 days, 12 months, 24 months
Occurrence of depressive disorders
Time Frame: prior to procedure, discharge (up to 5 days), 90 days, 12 months, 24 months
Hemiltona depression scale - 0 to 50 point, the higher the score, the more severe the mood disorder
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
Time Frame: during LAAC procedure
during LAAC procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Silesian Centre for Heart Diseases

Collaborators

Medical University of Silesia
Biostat Sp. z o.o.
Leszek Giec Upper-Silesian Medical Centre

Investigators

  • Principal Investigator: Zbigniew F Kalarus, Prof., Silesian Centre for HEart Diseases in Zabrze

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

March 15, 2022

First Submitted That Met QC Criteria

May 5, 2022

First Posted (Actual)

May 11, 2022

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAAC-SBI ver. 3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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