Atrial FibrillationNCT03867227
Non-pharmacological Prevention of Stroke in Patients With Non-valvular Atrial Fibrillation
An observational study of Atrial Fibrillation, run by National Research Center for Preventive Medicine at 1 site in Russia.
Trial summary
Left atrial appendage (LAA) occlude devices are used for over ten years. According to current data efficiency and safety of this approach at least comparable with pharmacological prevention of stroke in patients with non-valvular atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- left atrial appendage occluder implantation
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteRussia
- Study dates
- 1 Dec 2018to 1 Dec 2022
- Phase
- Observational
- 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
Study population: Patients >18 years old with atrial fibrillation and high risk for tromboembolic events
Who may be able to join
- Patient with paroxysmal/persistent/permanent atrial fibrillation
- CHA2DS2VASc score ≥2 for male and ≥3 for female
- Without contraindications to anticoagulation therapy
Who cannot join
- LAA thrombosis
- mechanical prosthetic heart valve
- moderate or severe mitral valve stenosis
Trial locations and contacts
1 site in 1 country.
Russia1 site
. National Research Center for Preventive Medicine of the Ministry of Health
Moscow, 101990
About this study
Left atrial appendage (LAA) occlude devices are used for over ten years. According to current data efficiency and safety of this approach at least comparable with pharmacological prevention of stroke in patients with non-valvular atrial fibrillation.
However, to date, LAA occluder implantation is not recommended as an alternative for conservative therapy and reserved for patients with contraindications for oral anticoagulants only. In the same time, long-term follow-up of patients enrolled in clinical trials and data from registries showed that LAA occlude device implantation as an alternative to oral anticoagulation could reduce drug load, decrease complexity and cost of treatment and thus improve patients' quality of life, and potentially may reduce the risk of death. The aim of our study is to investigate the risk of all-cause death, stroke, and bleedings in patients with LAA occluder implanted as an alternative to anticoagulant therapy.
Read more
Three hundred patients with atrial fibrillation will undergo LAA occluder implantation. For LAA occluder sizing transesophageal echocardiography (TEE), CT and LAA angiography will be performed. The follow-up period will be 36 months. The incidence of all-cause death, stroke, bleeding BARC≥2, device-related complications and QOL will be investigated.
The patients will be followed in the clinic at three and six months, and then at 12, 24 and 36 months, the telephone calls for getting information about endpoints events will be done. Additional in clinic visits will be scheduled if the late complications will be suspected.
TEE will be performed at three and six months to check for device leak, displacement and thrombosis.
- Conditions
- Atrial Fibrillation
- Being tested
- left atrial appendage occluder implantation
- Keywords
- left atrial appendage, LAA occluder, thromboembolic prophylaxis, atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
left atrial appendage occluder implantationDevice
all patients will get implantation of LAA occluder
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with Composite of death, stroke, clinically significant bleeding event (>_2 class according to BARC criteria), device leak, device displacement or device thrombosis with the first event for a given patient is taken into account
a clinically significant bleeding event is >_2 class according to Bleeding Academic Research Consortium (BARC) criteria bleeding
Measured: 36 months
Secondary outcomes (8)
device thrombosis during first 6 months
device thrombosis detected by transesophageal echocardiography during first 6 months of follow-up
Measured: 6 months
device dislocation
number of patients who would have device dislocation
Measured: 36 months
any bleed
total number of patients who would have any bleeding event
Measured: 36 months
bleeding BARC ≥2
total number of patients who would have bleeding event with the grade BARC ≥2
Measured: 36 months
device leak and displacement during first 6 months
device leak detected by transesophageal echocardiography during first 6 months after implantation or device displacement during the same time period
Measured: 6 months
any adverse events during 7 days after LAA occluder implantation
any adverse events related to the device implantation during the first 7 days after implantation
Measured: 7 days
change in QOL SF 36 between baseline and final visit
change in quality of life (QOL) by Short Form (SF) 36 Health Survey between baseline and follow-up visits
SF 36 is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health. 0-100 scale are using to access each domain. lower the score the more disability.
Measured: Assessed at baseline and 6-month follow-up visits
the percent of patients in whom long -term anticoagulation therapy would add during follow-up
number of patients who would require adding permanent anticoagulant therapy for any reason during follow-up
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start1 Dec 2018
- Primary completion1 Dec 2021
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Center for Preventive Medicine
- Sponsor type
- Other government
- Collaborators
- National Medical Research Center for Cardiology, Ministry of Health of Russian Federation, National Research Center of Surgery, Russia, I.M. Sechenov First Moscow State Medical University, Medical and Rehabilitation center
- Responsible party
- Sponsor
- Investigators
- Karapet Davtyan, Principal investigator, National Research Center for Preventive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03867227
- Sponsor's protocol ID
- 2018/10/21
- Status last verified
- Mar 2023
- First submitted
- 6 Feb 2019
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-pharmacological Prevention of Stroke in Patients With Non-valvular Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03867227
- Acronym / sponsor ID
- 2018/10/21
- Conditions
- Atrial Fibrillation
- Keywords
- left atrial appendage, LAA occluder, thromboembolic prophylaxis, atrial fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- National Research Center for Preventive MedicineOther government
- Collaborators
- National Medical Research Center for Cardiology, Ministry of Health of Russian Federation, National Research Center of Surgery, Russia, I.M. Sechenov First Moscow State Medical University, Medical and Rehabilitation center
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 7 Mar 2019 (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.
Left atrial appendage (LAA) occlude devices are used for over ten years. According to current data efficiency and safety of this approach at least comparable with pharmacological prevention of stroke in patients with non-valvular atrial fibrillation.
However, to date, LAA occluder implantation is not recommended as an alternative for conservative therapy and reserved for patients with contraindications for oral anticoagulants only. In the same time, long-term follow-up of patients enrolled in clinical trials and data from registries showed that LAA occlude device implantation as an alternative to oral anticoagulation could reduce drug load, decrease complexity and cost of treatment and thus improve patients' quality of life, and potentially may reduce the risk of death. The aim of our study is to investigate the risk of all-cause death, stroke, and bleedings in patients with LAA occluder implanted as an alternative to anticoagulant therapy.
Three hundred patients with atrial fibrillation will undergo LAA occluder implantation. For LAA occluder sizing transesophageal echocardiography (TEE), CT and LAA angiography will be performed. The follow-up period will be 36 months. The incidence of all-cause death, stroke, bleeding BARC≥2, device-related complications and QOL will be investigated.
The patients will be followed in the clinic at three and six months, and then at 12, 24 and 36 months, the telephone calls for getting information about endpoints events will be done. Additional in clinic visits will be scheduled if the late complications will be suspected.
TEE will be performed at three and six months to check for device leak, displacement and thrombosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients >18 years old with atrial fibrillation and high risk for tromboembolic events
Key inclusion criteria (3 listed)
- Patient with paroxysmal/persistent/permanent atrial fibrillation
- CHA2DS2VASc score ≥2 for male and ≥3 for female
- Without contraindications to anticoagulation therapy
Key exclusion criteria (3 listed)
- LAA thrombosis
- mechanical prosthetic heart valve
- moderate or severe mitral valve stenosis
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 |
|---|---|---|
| left atrial appendage occluder implantationall patients will get implantation of LAA occluder | Device | – |
Primary outcome
Number of patients with Composite of death, stroke, clinically significant bleeding event (>_2 class according to BARC criteria), device leak, device displacement or device thrombosis with the first event for a given patient is taken into account
Time frame: 36 months
a clinically significant bleeding event is >_2 class according to Bleeding Academic Research Consortium (BARC) criteria bleeding
8 secondary outcomes
device thrombosis during first 6 months
Time frame: 6 months
device dislocation
Time frame: 36 months
any bleed
Time frame: 36 months
bleeding BARC ≥2
Time frame: 36 months
device leak and displacement during first 6 months
Time frame: 6 months
any adverse events during 7 days after LAA occluder implantation
Time frame: 7 days
change in QOL SF 36 between baseline and final visit
Time frame: Assessed at baseline and 6-month follow-up visits
the percent of patients in whom long -term anticoagulation therapy would add during follow-up
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
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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.
Karapet Davtyan principal investigator
National Research Center for Preventive Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by National Research Center for Preventive Medicine at 1 site in Russia.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with Composite of death, stroke, clinically significant bleeding event (>_2 class according to BARC criteria), device leak, device displacement or device thrombosis with the first event for a given patient is taken into account (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2023.