Evaluating the Safety and Effectiveness of the Laminar Le... | NCT04807283

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

NCT04807283

Sponsor

Laminar, Inc.

Status

Unknown status

Last Update Posted

Oct 3, 2023Actual

Enrollment

29Actual

Phase

Not Applicable

Conditions

Atrial Fibrillation

Interventions

Left Atrial Appendage Closure

Countries

Georgia
Paraguay

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

Oct 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 5, 2021Actual

Primary Completion Date

Nov 26, 2021Actual

Completion Date

Dec 2023Estimated

First Submitted Date

Mar 17, 2021

First Submission Date that Met QC Criteria

Mar 17, 2021

First Posted Date

Mar 19, 2021Actual

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

Oct 2, 2023

Last Update Posted Date

Oct 3, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief 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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

29Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment	Experimental		Device: Left Atrial Appendage Closure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Left Atrial Appendage Closure	Device	Closure or occlusion of the left atrial appendage to reduce the risk of thromboembolism in patients with NVAF	Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Freedom from device or procedure related serious adverse events		7 days
Confirmation of functional LAA closure as defined by residual peri-device flow ≤ 5mm per TEE		45 days

Secondary Outcomes

Measure	Description	Time Frame
Absence of all-cause mortality, major bleeding, ischemic stroke, or systemic embolism		45 days and 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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.

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Israeli-Georgian Medical Research Clinic Helsicore		Tbilisi			Georgia
Tbilisi Heart and Vascular Clinic

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

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

Intervention Browse Module

MeSH Terms

ID	Term
D000097546	Left Atrial Appendage Closure

Ancestor Terms

ID	Term
D006328	Cardiac Catheterization
D002404	Catheterization
D013812	Therapeutics
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided