Clinical Investigation of the LAmbre Left Atrial Appendage Closure System

A Prospective, Non-Randomized, Multi-Center, Open-Label, Non-Comparative, Interventional 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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: LAA closure system

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: LAmbre closure system	Device: LAA closure system; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious adverse events	Absence of device or procedure related serious adverse events at 6 months after device implantation	6 months
Stable device placement	Stable device placement in left atrial appendage as assessed by transesophageal echocardiogram (TEE) at 6 months after device implant	6 months
Residual jet flow	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	6 months

Collaborators and Investigators

• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
• Investigators: Principal Investigator: Horst Sievert, The Cardiovascular Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 5, 2013
• Primary Completion (ACTUAL): March 9, 2016
• Study Completion (ACTUAL): November 9, 2016

Study Registration Dates

• First Submitted: April 17, 2017
• First Submitted That Met QC Criteria: April 17, 2017
• First Posted (ACTUAL): April 20, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 21, 2017
• Last Update Submitted That Met QC Criteria: April 19, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: LAmbre
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: LA-EU-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No