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Can the Lambre Device Occlude IRRegular And Large Appendages in Patients With Non-Valvular AF

NCT04684212 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-11-04

No results posted yet for this study

Summary

The primary objective is to demonstrate the safety and efficacy of the implantation of the LAmbre PlusTM device in patients with large or irregularly shaped appendages with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism compared to oral anticoagulation (OAC).

Conditions

Interventions

DEVICE

LAmbre PlusTM Left Atrial Appendage Closure System

The LAmbre Plus device is a self-expanding occluder, composed of a distal Umbrella and a proximal Cover laser welded together, delivered percutaneously via femoral venous access and trans-septal puncture. The distal Umbrella consists of an elastic nitinol frame and outer PET membrane, and has circumferential anchors to secure the occluder to the left atrial appendage (LAA) wall. The proximal Cover is a disc of elastic nitinol mesh, which seals the orifice of the LAA and minimizes thrombus formation, and includes a PET membrane to prevent the passage of blood into the LAA after implantation.

DRUG

Market approved oral anticoagulation (OAC), such as warfarin (Coumadin), dabigatran (Pradaxa), rivaroxaban (Xarelto), apixiban (Eliquis), edoxaban (Savaysa), or betrixaban (Bevyxxa)

Continuation of market approved OAC drug.

Sponsors & Collaborators

  • Lifetech Scientific (Shenzhen) Co., Ltd.

    collaborator INDUSTRY

  • Brian O'Neill MD

    lead OTHER

Principal Investigators

  • Brian O'Neill, MD · Henry Ford Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2024-06-01
Completion
2024-07-11
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04684212 on ClinicalTrials.gov