Russian National Registry of LAAO | NCT04322474

Studies
Russian National Registry of LAAO

NCT04322474

Sponsor

National Research Center for Preventive Medicine

Status

Completed

Last Update Posted

Mar 26, 2020Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

Catheter-based left atrial appendage occlusion

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2015Actual

Primary Completion Date

Dec 30, 2017Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

Mar 24, 2020

First Submission Date that Met QC Criteria

Mar 25, 2020

First Posted Date

Mar 26, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2020

Last Update Posted Date

Mar 26, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Catheter-based left atrial appendage occlusion	Device	Catheter-based implantation of left atrial appendage occluder

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Procedure-related major adverse events (pericardial effusion, cardiac tamponade, device embolization, procedure/device-related death)		12 months
The composite of thromboembolic events, device thrombosis, hemorrhagic events, unexplained death	Primary efficacy endpoint	12 months

Secondary Outcomes

Measure	Description	Time Frame
Procedure success rate	successful left atrial appendage occluder implantation rate	intraprocedural
Peridevice leakage	incidence rates of significant (≥5mm) leakage

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age ≥18 years nonvalvular atrial fibrillation,
CHA2DS2VASc ≥2,
high risk of hemorrhagic events,
non-compliance with pharmacological anticoagulant therapy

Exclusion Criteria:

significant mitral valve disease,
left ventricular ejection fraction <35%,
the tendency to systemic thrombosis,
severe co-morbidities

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Nonvalvular atrial fibrillation patients with a high risk of thromboembolic and haemorrhagic events

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karapet Davtyan, PhD	National Research Center for Preventive Medicine	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided