Clinical Investigation of the LAmbre Left Atrial Appendage Closure System

The aim of the study LA-EU-01 was to examine the safety and the feasibility of the LAmbreTM Left Atrial Appendage Closure System in patients with non-valvular paroxymal, persistent or permanent atrial fibrillation, by using imaging approaches, i.e. combined trans-esophageal and transthoracic echocardiography.

The conducted LA-EU-01 study was a prospective, non-randomized, multi-center, open-label, non-comparative, interventional clinical investigation with the participation of two clinical centers in Germany and the inclusion of 61 subjects.

Participating subjects were patients with non-valvular paroxymal, persistent or permanent atrial fibrillation with long-term sustainability and scheduled for interventional closure of the left atrial appendage who could not be treated with anticoagulation.

After the procedure of implantation of the LAmbreTM Left Atrial Appendage Closure System, patients underwent a first follow up assessment prior to hospital discharge then at 30 days, 6 and 12 months.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age ≥18 years
Patients scheduled for interventional closure of the left atrial appendage (LAA) due to a high thromboembolic risk and cannot be treated with anticoagulation.
Chronic atrial fibrillation ≥3 months; paroxysmal, persistent or permanent nonvalvular Atrial Fibrilation (AF)
CHA2DS2 -VASC score 2 or higher
Eligible for clopidogrel and aspirin
Able to understand the requirements of the study and willing to follow study instructions, provide written informed consent, and agree to comply with all study requirements, including the required study follow-up visits

Exclusion criteria

Presence of rheumatic, degenerative or congenital valvular heart diseases
Presence of rheumatic, degenerative or congenital valvular heart diseases
The diameter of left atrium ≥65 mm
LAA Ostium < 12mm or > 30 mm
Prior surgical removal of Left atrium
Prior heart transplant
Symptomatic patients with carotid artery disease (such as carotid stenosis ≥ 50%)
Recent or acute myocardial infarction (MI) or unstable angina (recent is defined as within 3 months of implant date)
Decompensated heart failure (NYHA grade III-IV)
Patients have an electrophysiological ablation procedure planned within 30 days of potential the LAmbreTM Left Atrial Appendage Closure System implant date
Patients have a planned electrophysiologic 30 days post implantation of the LAmbreTM Left Atrial Appendage Closure System
Patients have a planned cardioversion 30 days post implantation of the LAmbreTM Left Atrial Appendage Closure System
Patients with a history of heart valve replacement operation with an mechanical prosthesis
History of stroke or Transient Ischemic Attack (TIA) within 30 days
Have thrombocytopenia (platelet ≤ 100.000 platelets per microliter (mcL))
Heart rate in rest > 110 beats per minute (BPM)
A single episode of transient atrial fibrillation
Pericardial effusion > 5mm pre-procedural
Presence of active sepsis or endocarditis
Cardiac tumors or other malignancy with estimated life expectancy less than 2 years
Patients who are pregnant, breastfeeding, or desires to become pregnant during the course of the study
Participation in the other investigational trials in which the primary endpoint is not met yet
Subject dependency of the Sponsor, of the institution in which the trail is conducted, or of the investigator
Investigator expectation that the patient will not be able to complete the trial according to the requirements
A known allergy to nitinol Esophageal ultrasonic exclusion criteria
LVEF ≤ 30 %
Presence of thrombus in the left atrial appendage (LAA)
Patent Foramen Ovale (PFO) with history of paradoxical embolism
Mitral valve stenosis (Mitral valve area ≤ 2 cm2)
Presence of complex aortic plaque (≥4mm) in ascending aorta

Treatment and study plan

LAA closure system

Device

Patients with non-valvular paroxymal, persistent or permanent atrial fibrillation with long-term sustainability and cannot be treated with anticoagulation and scheduled for interventional left atrial appendage closure.

Primary outcomes

Serious adverse events

Time frame: 6 months

Absence of device or procedure related serious adverse events at 6 months after device implantation
Stable device placement

Time frame: 6 months

Stable device placement in left atrial appendage as assessed by transesophageal echocardiogram (TEE) at 6 months after device implant
Residual jet flow

Time frame: 6 months

Successful sealing around the device at the LAA orifice (residual jet flow of < 5 mm) as measured by transesophageal echocardiogram (TEE) at 6 months after device implant

Sponsors and collaborators

Lead sponsor

Lifetech Scientific (Shenzhen) Co., Ltd.

Industry

Registry information

Official study title

A Prospective, Non-Randomized, Multi-Center, Open-Label, Non-Comparative, Interventional Clinical Investigation of the LAmbre Left Atrial Appendage Closure System

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2016
First posted: Apr 20, 2017
Registry last updated: Apr 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed