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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-05

Study Completion Date

2023-12-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Treatment

Group Type EXPERIMENTAL

Left Atrial Appendage Closure

Intervention Type DEVICE

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

Interventions

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Left Atrial Appendage Closure

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

Intervention Type DEVICE

Other Intervention Names

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Left Atrial Appendage Occlusion

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No