Clinical Investigation of the LAmbre Left Atrial Appendage Closure System

April 19, 2017 updated by: Lifetech Scientific (Shenzhen) Co., Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
61

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Serious adverse events
Time Frame: 6 months
Absence of device or procedure related serious adverse events at 6 months after device implantation
6 months
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
6 months
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lifetech Scientific (Shenzhen) Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Horst Sievert, The Cardiovascular Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 5, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 9, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 9, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 21, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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