Atrial FibrillationLAAC-SBINCT05369195
Cerebral Protection in Transcatheter Left Atrial Appendage Occlusion
A study testing LAAC procedure with the use of transcatheter cerebral protection system and LAAC procedure without the use of transcatheter cerebral protection system in people with Atrial Fibrillation and Silent Stroke, run by Silesian Centre for Heart Diseases at 6 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Silent Stroke, Cognitive Impairment
- What is being tested?
- LAAC procedure with the use of transcatheter cerebral protection system and LAAC procedure without the use of transcatheter cerebral protection system
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 6 sitesPoland
- Study dates
- 26 May 2023to Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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
Who cannot join
- 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
- The use of antidepressants in 3 months prior inclusion.
- Previous infections of the central nervous system, including neuroborreliosis
Show all 33Show fewer
- 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
- The presence of mechanical heart valve prostheses
- The state after the operative closure of the defect in the atrial septum
- Condition after closing the defect in the interatrial septum with the use of occluders
- Active infective endocarditis
- Presence of devices and prostheses that prevent the performance of MRI (pacemakers, clips in the CNS)
- Status after oesophagal surgery
- Esophageal diverticula
- Esophageal varices> grade 3
- Allergic to contrast agents
- A contraindication to use antiplatelet drugs
- Diagnosis of neoplastic disease with estimated survival beyond 1 year
- Clininally evident hypothyroidism and hyperthyroidism
- Klaustrofobia
- Pregnancy
- AIDS
- Participation in other drug research studies
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Poland6 sites, 6 recruiting
- Not yet recruiting
Górnośląskie Centrum Medyczne im. prof. Leszka Gieca Śląskiego Uniwesryeteu Medycznego
Katowice, 40-635
Klaudia Rogowska, +48 32 3598313, dyrektor@gcm.pl
Wojciech Wojakowski, Prof., +48 32 252 39 30, wwojakowski@sum.edu.pl
- Not yet recruiting
Klinika Chorób Serca i Naczyń, Krakowski Szpital Specjalistyczny im. Jana Pawła II
Krakow, 31-202
Tadeusz Przewłocki, Prof., tadeuszprzewlocki@op.pl
Tadeusz Przewłocki, Prof.
- 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
Marek Grygier, Prof., marek.grygier@skpp.edu.pl
Marek Grygier
- Not yet recruiting
Klinika Kardiologii i Chorób Wewnętrznych, Wojskowy Instytut Medyczny
Warsaw, 04-141
Piotr Kwiatkowski, MD, pkwiatkowski@wim.mil.pl
Piotr Kwiatkowski, MD
- Not yet recruiting
Klinika Choroby Wieńcowej i Strukturalnych Chorób Serca, Narodowy Instytut Kardiologii Stefana kardynała Wyszyńskiego - Państwowy Instytut Badawczy
Warsaw, 04-625
Marcin Demkow, Prof., m.demkow@ikard.pl
Marcin Demkow, Prof.
- Recruiting
Silesian Centre for HEart Diseases in Zabrze
Zabrze, 41-800
Witold Streb, Ph.D, +48 32 2713414, w.streb@sccs.pl
Zbigniew Kalarus, Prof., +48 32 37 33 682, karzab@sum.edu.pl
About this study
Official title: 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.
Read the 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.
- Conditions
- Atrial Fibrillation, Silent Stroke, Cognitive Impairment, Depression
- Being tested
- LAAC procedure with the use of transcatheter cerebral protection system, LAAC procedure without the use of transcatheter cerebral protection system
- Keywords
- cerebral protection, left atrial appendage occlusion, atrial fibrillation, silent brain ischemia, cognitive impairment, depression
- Medical subject headings
- Atrial Fibrillation, Cognitive Dysfunction, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAAC procedure with the use of transcatheter cerebral protection systemProcedure or surgery
After aortography the cerebral protection system will be delivered to cerebral arteries through radial access before accessing the left atrium.
LAAC procedure without the use of transcatheter cerebral protection systemProcedure or surgery
Only the aortography through radial access will be done before accessing the left atrium.
| Study group | Role | What they receive |
|---|---|---|
| LAAC with neuroprotection | Experimental | Arm in which is used a transcatheter system to protect the cerebral circulation during the left atrial appendage closure procedures. Receives: 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. Receives: Procedure: LAAC procedure without the use of transcatheter cerebral protection system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of silent cerebral ischemia (SBI) foci
number of SBI foci in DW MRI of the brain
Measured: 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
Measured: change in the period up to 24 months
Secondary outcomes (5)
Deterioration of cognitive functions
Montreal Cognitive Assessment (MoCA) test (scoring 0-30; cut-off value <26)
Measured: prior to procedure, discharge (up to 5 days), 90 days, 12 months, 24 months
Deterioration of cognitive functions
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.
Measured: prior to procedure, discharge (up to 5 days), 90 days, 12 months, 24 months
Development of dementia
diagnosis made by a specialist neurologist
Measured: prior to procedure, discharge (up to 5 days), 90 days, 12 months, 24 months
Occurrence of depressive disorders
Hemiltona depression scale - 0 to 50 point, the higher the score, the more severe the mood disorder
Measured: 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
Measured: during LAAC procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start26 May 2023
- Primary completion31 Dec 2025 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Silesian Centre for Heart Diseases
- Sponsor type
- University, hospital or other
- Collaborators
- Leszek Giec Upper-Silesian Medical Centre, Medical University of Silesia, Biostat Sp. z o.o.
- Responsible party
- Sponsor
- Investigators
- Zbigniew F Kalarus, Prof., Principal investigator, Silesian Centre for Heart Diseases in Zabrze
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369195
- Sponsor's protocol ID
- LAAC-SBI ver. 3
- Acronym
- LAAC-SBI
- Status last verified
- Mar 2023
- First submitted
- 15 Mar 2022
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37996955
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Protection in Transcatheter Left Atrial Appendage Occlusion in Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT05369195
- Acronym / sponsor ID
- LAAC-SBI / LAAC-SBI ver. 3
- Conditions
- Atrial Fibrillation, Silent Stroke, Cognitive Impairment, Depression
- Keywords
- cerebral protection, left atrial appendage occlusion, atrial fibrillation, silent brain ischemia, cognitive impairment, depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Silesian Centre for Heart DiseasesUniversity, hospital or other
- Collaborators
- Leszek Giec Upper-Silesian Medical Centre, Medical University of Silesia, Biostat Sp. z o.o.
- Study start
- 26 May 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 11 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LAAC with neuroprotection | Experimental | Procedure: LAAC procedure with the use of transcatheter cerebral protection systemArm in which is used a transcatheter system to protect the cerebral circulation during the left atrial appendage closure procedures. |
| LAAC without neuroprotection | Placebo comparator | Procedure: LAAC procedure without the use of transcatheter cerebral protection systemArm in which the left atrial appendage closure procedures are performed without transcatheter cerebral protection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 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:
Key exclusion criteria (33 listed)
- 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
- The use of antidepressants in 3 months prior inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LAAC procedure with the use of transcatheter cerebral protection systemAfter aortography the cerebral protection system will be delivered to cerebral arteries through radial access before accessing the left atrium. | Procedure or surgery | LAAC with neuroprotection |
| LAAC procedure without the use of transcatheter cerebral protection systemOnly the aortography through radial access will be done before accessing the left atrium. | Procedure or surgery | LAAC without neuroprotection |
Primary outcome
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 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
5 secondary outcomes
Deterioration of cognitive functions
Time frame: 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
Development of dementia
Time frame: 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
Presence of embolic material in the filters of the neuroprotection device
Time frame: during LAAC procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Derived from this study: PubMed 37996955Streb 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zbigniew F Kalarus, Prof. principal investigator
Silesian Centre for Heart Diseases in Zabrze
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LAAC procedure with the use of transcatheter cerebral protection system and LAAC procedure without the use of transcatheter cerebral protection system in people with Atrial Fibrillation and Silent Stroke, run by Silesian Centre for Heart Diseases at 6 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Witold A Streb, Ph.D. (0048322713414, w.streb@sccs.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number of silent cerebral ischemia (SBI) foci (time frame: change in the period up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05369195, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.