Clinical Investigation of the LAmbre Left Atrial Appendage Closure System

NCT03122028 | Completed

• 1 other identifier: LA-EU-01
• Study Type: interventional
• Target: 61
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Atrial Fibrillation

Keywords

LAmbre

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

LAmbre closure system

EXPERIMENTAL

Device: LAA closure system

Interventions

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.

LAmbre closure system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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))

Sponsors & Collaborators

• Lifetech Scientific (Shenzhen) Co., Ltd.: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Horst Sievert

  The Cardiovascular Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: April 20, 2017
• Study Start: November 5, 2013
• Primary Completion: March 9, 2016
• Study Completion: November 9, 2016
• Last Updated: April 21, 2017

Record last verified: 2017-04