Clinical Investigation of the LAmbre Left Atrial Appendage Closure System
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
LAA closure system
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring LAmbre
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LAmbre closure system
Arm Description
Outcomes
Primary Outcome Measures
Serious adverse events
Absence of device or procedure related serious adverse events at 6 months after device implantation
Stable device placement
Stable device placement in left atrial appendage as assessed by transesophageal echocardiogram (TEE) at 6 months after device implant
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03122028
First Posted
April 17, 2017
Last Updated
April 19, 2017
Sponsor
Lifetech Scientific (Shenzhen) Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03122028
Brief Title
Clinical Investigation of the LAmbre Left Atrial Appendage Closure System
Official Title
A Prospective, Non-Randomized, Multi-Center, Open-Label, Non-Comparative, Interventional Clinical Investigation of the LAmbre Left Atrial Appendage Closure System
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 5, 2013 (Actual)
Primary Completion Date
March 9, 2016 (Actual)
Study Completion Date
November 9, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lifetech Scientific (Shenzhen) Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
LAmbre
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LAmbre closure system
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
LAA closure system
Intervention Description
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 Outcome Measure Information:
Title
Serious adverse events
Description
Absence of device or procedure related serious adverse events at 6 months after device implantation
Time Frame
6 months
Title
Stable device placement
Description
Stable device placement in left atrial appendage as assessed by transesophageal echocardiogram (TEE) at 6 months after device implant
Time Frame
6 months
Title
Residual jet flow
Description
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
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Horst Sievert
Organizational Affiliation
The Cardiovascular Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Clinical Investigation of the LAmbre Left Atrial Appendage Closure System
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