Atrial FibrillationNCT04322474
Russian National Registry of LAAO
An observational study of Atrial Fibrillation, run by National Research Center for Preventive Medicine.
Trial summary
The first Russian registry presents data from two hundred consecutive patients with nonvalvular atrial fibrillation, who undergone left atrial appendage occlusion (LAAO) using the Watchman device and the Amplatzer cardiac plug. 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?
- Catheter-based left atrial appendage occlusion
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2015to 31 Dec 2018
- How long will I take part?
- 12 Months
- 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: Nonvalvular atrial fibrillation patients with a high risk of thromboembolic and haemorrhagic events
Who may be able to join
- age ≥18 years nonvalvular atrial fibrillation,
- CHA2DS2VASc ≥2,
- high risk of hemorrhagic events,
- non-compliance with pharmacological anticoagulant therapy
Who cannot join
- significant mitral valve disease,
- left ventricular ejection fraction <35%,
- the tendency to systemic thrombosis,
- severe co-morbidities
About this study
Official title: Russian National Registry of Left Atrial Appendage Occlusion
The first Russian registry presents data from two hundred consecutive patients with nonvalvular atrial fibrillation, who undergone left atrial appendage occlusion (LAAO) using the Watchman device and the Amplatzer cardiac plug. This government-funded catheter-based LAAO program was started in September 2015 and was completed in December 2017. Data collection was finished in December 2018. Five clinics agreed to participate in the study.
Patients' baseline characteristics, procedure, and follow up data were collected according to established registry protocol. Patients were followed at 45 days, 3, 6 and 12 months after enrollment. At each follow-up visit, the data regarding clinical events and healthcare utilization was collected.
- Conditions
- Atrial Fibrillation
- Being tested
- Catheter-based left atrial appendage occlusion
- Keywords
- atrial fibrillation, left atrial appendage, stroke prevention, occluder, Watchman device, Amplatzer Cardiac Plug
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter-based left atrial appendage occlusionDevice
Catheter-based implantation of left atrial appendage occluder
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure-related major adverse events (pericardial effusion, cardiac tamponade, device embolization, procedure/device-related death)
Measured: 12 months
The composite of thromboembolic events, device thrombosis, hemorrhagic events, unexplained death
Primary efficacy endpoint
Measured: 12 months
Secondary outcomes (2)
Procedure success rate
successful left atrial appendage occluder implantation rate
Measured: intraprocedural
Peridevice leakage
incidence rates of significant (≥5mm) leakage
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start1 Sep 2015
- Primary completion30 Dec 2017
- Study completion31 Dec 2018
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
- 200 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- National Research Center for Preventive Medicine
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Karapet Davtyan, PhD, Principal investigator, National Research Center for Preventive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04322474
- Sponsor's protocol ID
- 8-5
- Status last verified
- Mar 2020
- First submitted
- 24 Mar 2020
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Russian National Registry of Left Atrial Appendage Occlusion
- ClinicalTrials.gov ID
- NCT04322474
- Acronym / sponsor ID
- 8-5
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, left atrial appendage, stroke prevention, occluder, Watchman device, Amplatzer Cardiac Plug
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- National Research Center for Preventive MedicineOther government
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 26 Mar 2020 (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 first Russian registry presents data from two hundred consecutive patients with nonvalvular atrial fibrillation, who undergone left atrial appendage occlusion (LAAO) using the Watchman device and the Amplatzer cardiac plug. This government-funded catheter-based LAAO program was started in September 2015 and was completed in December 2017. Data collection was finished in December 2018. Five clinics agreed to participate in the study.
Patients' baseline characteristics, procedure, and follow up data were collected according to established registry protocol. Patients were followed at 45 days, 3, 6 and 12 months after enrollment. At each follow-up visit, the data regarding clinical events and healthcare utilization was collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Nonvalvular atrial fibrillation patients with a high risk of thromboembolic and haemorrhagic events
Key inclusion criteria (4 listed)
- age ≥18 years nonvalvular atrial fibrillation,
- CHA2DS2VASc ≥2,
- high risk of hemorrhagic events,
- non-compliance with pharmacological anticoagulant therapy
Key exclusion criteria (4 listed)
- significant mitral valve disease,
- left ventricular ejection fraction <35%,
- the tendency to systemic thrombosis,
- severe co-morbidities
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 |
|---|---|---|
| Catheter-based left atrial appendage occlusionCatheter-based implantation of left atrial appendage occluder | Device | – |
Primary outcome
Procedure-related major adverse events (pericardial effusion, cardiac tamponade, device embolization, procedure/device-related death)
Time frame: 12 months
The composite of thromboembolic events, device thrombosis, hemorrhagic events, unexplained death
Time frame: 12 months
Primary efficacy endpoint
2 secondary outcomes
Procedure success rate
Time frame: intraprocedural
Peridevice leakage
Time frame: 6 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 26 Mar 2020.
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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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, PhD principal investigator
National Research Center for Preventive Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by National Research Center for Preventive Medicine.
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 4 inclusion and 4 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 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Procedure-related major adverse events (pericardial effusion, cardiac tamponade, device embolization, procedure/device-related death) (time frame: 12 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?
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 26 Mar 2020.