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Status unknownNCT04807283Updated Oct 3, 2023

Evaluating the Safety and Effectiveness of the Laminar Left Atrial Appendage Closure System

An interventional study of Left Atrial Appendage Closure in Atrial Fibrillation, sponsored by Laminar, Inc.. Status unknown at 4 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-03.

Sponsored by Laminar, Inc. (part of Johnson & Johnson) · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Oct 2023), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
29
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The objective of this study is to demonstrate safety and effectiveness using a percutaneous Delivery System of the Laminar Left Atrial Appendage Closure System to treat patients with NVAF to reduce the risk of thromboembolism from the left atrial appendage (LAA).

02

Conditions studied

  • Atrial Fibrillation

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Keywords

  • Left Atrial Appendage Closure
03

In context

Atrial Fibrillation

3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.

This study's enrollment of 29 is below the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Laminar, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

First submitted before Laminar, Inc. became part of Johnson & Johnson.

Browse Laminar, Inc. studies →All Johnson & Johnson studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 1. Subject must have a documented history of paroxysmal, persistent or permanent nonvalvular atrial fibrillation (AF).
  • 2. Subject must be ≥18 years of age.
  • 3. Subject has a calculated CHA2DS2-VASc score of 2 or greater.
  • 4. Subject must be clinically stable on warfarin (or other anticoagulant) therapy for a minimum of three months.
  • 5. Subject must have at least two International Normalized Ratios (INRs); 2-3, if on Warfarin.
  • 6. Subject is eligible for the defined protocol pharmacologic regimen of anticoagulation and antiplatelet therapy.

Exclusion criteria

Exclusion Criteria:

  • 1. Subject who requires anticoagulation for a condition other than AF.
  • 2. Subject with a New York Heart Association (NYHA) classification equal to IV.
  • 3. Subject with a history of or implanted atrial septal defect (ASD) device or patent foramen ovale (PFO) device that would interfere with the investigational device placement.
  • 4. Subject with valvular disease.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
29 participants (actual)

Study arms

  • Experimental
    Treatment

    Device: Left Atrial Appendage Closure

Interventions

  • DeviceLeft Atrial Appendage Closure

    Closure or occlusion of the left atrial appendage to reduce the risk of thromboembolism in patients with NVAF

    Also known as: Left Atrial Appendage Occlusion

06

What researchers measure

Primary outcomes

  1. Freedom from device or procedure related serious adverse events

    Time frame: 7 days

  2. Confirmation of functional LAA closure as defined by residual peri-device flow ≤ 5mm per TEE

    Time frame: 45 days

Secondary outcomes

  1. Absence of all-cause mortality, major bleeding, ischemic stroke, or systemic embolism

    Time frame: 45 days and 6 months

07

Study locations

4 sites
  • Israeli-Georgian Medical Research Clinic Helsicore
    Tbilisi, Georgia
  • Tbilisi Heart and Vascular Clinic
    Tbilisi, Georgia
  • Sanatorio Italiano Hospital
    Asunción, Paraguay
  • Hospital de Clinicas San Lorenzo, National University
    San Lorenzo, Paraguay
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2021 to primary completion in Nov 2021, 8 months.

Of 242 industry-sponsored interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 36. This study's 8 months is below that.

Counting every sponsor, half of 1,031 studies reached it within 34 months; a quarter within 18 and three quarters within 54.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 17, 2021
First posted
Mar 19, 2021
StartActual
Mar 5, 2021
Primary completionActual
Nov 26, 2021
CompletionEst.
Dec 2023
Last update
Oct 3, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04807283
Lead sponsor
Laminar, Inc.
Responsible party
Sponsor
First posted
Mar 19, 2021
Start date
Mar 5, 2021
Primary completion
Nov 26, 2021
Completion
Dec 2023 (estimated)
Last update
Oct 3, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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