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Feasibility and Safety Study of LAmbre Left Atrial Appendage Occluder

Primary Purpose

Atrial Fibrillation, Stroke

Status

Completed

Phase

Early Phase 1

Locations

China

Study Type

Interventional

Intervention

LAmbre Left Atrial Appendage(LAA) Occluder

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Thrombosis, Ischemic stroke, Left atrial appendage occluder, Intervention method

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient is ≥18 years of age;
Chronic atrial fibrillation ≥3 months; paroxysmal, persistent or permanent non-valvular AF;
CHADS2-VAS score 2 or higher;
Patient can understand the trial purpose, voluntarily join this clinical trial with informed consent;
Patient voluntarily completes the follow-up and follow-up inspection in accordance with the clinical trials process.

Exclusion Criteria:

A. Clinical exclusion criteria
1. Presence of rheumatic, degenerative or congenital valvular heart diseases,
2. The diameter of left atrial ≥65 mm;
3. LAA size < 12mm or > 30 mm
4. Left atrium has been removed;
5. Heart transplantation patients;
6. Symptomatic patients with carotid artery disease (such as carotid stenosis ≥ 50%);
7. Acute myocardial infarction or unstable angina;
8. Decompensated heart failure (New York Heart Association functional class III-IV);
9. Recent myocardial infarction (< 3 months);
10. Patients with an atrial septal defect or received an atrial septal occluder. The patient has an ablation procedure planned within 30 days of potential LAmbre Occluder implant
11. The patient has a planned cardioversion 30 days post implant of the LAmbre Occluder
12. Patient who after artificial mechanical heart valve replacement operation;
13. Uncontrolled Heart rate ≥ 110 beats / min17) History stroke or TIA within 30 days;
14. Presence of complex aortic plaque(4mm) in ascending aorta;
15. Cardiac tumors or other malignancy with estimated life expectancy u less than 2 years;
16. Have thrombocytopenia (platelet 《105 / μl) or anemia（Hb<10g/dl）;
17. Women who is pregnancy or plan to pregnancy during the trial period;
18. Presence of active sepsis or endocarditis;
19. Patient participated in the other trials;
20. The investigators expect the patient not be able to complete the trial according to requirements.

B. Esophageal ultrasonic exclusion criteria

LVEF≤30%;
Presence of left atrial appendage thrombus;
High risk PFO patients(presence of atrial septal aneurysm);
Have obvious mitral valve stenosis (the area of mitral valve≤ 2 cm2);
Have obvious and unexplained pericardial effusion(≥4 cm2).
Presence of complex aortic plague(≥4 mm) in ascending aorta.

Sites / Locations

Prince of Wales Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Left Atrial Appendage Occluder

Arm Description

Adopted non-comparative arm on Left Atrial Appendage Occluder.

Outcomes

Primary Outcome Measures

The feasibility end-point

stable device placement in left atrial appendage as assessed by angiography and trans-esophageal(TEE)and successful sealing around the device LAA orifice with the device(jet<3mm in width) as measured by TEE at 30 days after device implant

Secondary Outcome Measures

The composite safety and efficacy end-point

Safety:freedom of major adverse events such as pericardial effusion. Successful closure without evidence of residual shunt and ischemic stroke after 1 year confirmed by trans-esophageal(TEE) and electrocardiograph.

Full Information

NCT ID

NCT01920412

First Posted

August 8, 2013

Last Updated

August 6, 2018

Sponsor

Lifetech Scientific (Shenzhen) Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01920412

Brief Title

Feasibility and Safety Study of LAmbre Left Atrial Appendage Occluder

Official Title

A Prospective, Non-randomized, Multicenter, Open-label, Non-comparative, First-in-Man Study to Evaluate the Feasibility and Safety of LAmbre Left Atrial Appendage Occluder

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Completed

Study Start Date

October 2012 (undefined)

Primary Completion Date

October 2013 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lifetech Scientific (Shenzhen) Co., Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study mainly evaluated the feasibility and safety of LAmbre Left Atrial Appendage Occluder which is to prevent ischemic stroke caused by atrial fibrillation(AF).

Detailed Description

Atrial fibrillation (AF) is a common arrhythmia, its incidence increases with age. Thrombosis shed off caused by AF is one of the major causes of stroke. Most patients with AF suffer ischemic stroke that the thrombosis was from the left atrial appendage(LAA). The majority of patients with atrial fibrillation, the blood clots come from the left atrial appendage, so close the left atrial appendage can reduce cycle thromboembolism of the patients with AF. Now patients have cardiac surgery and risk at left atrium related thromboembolism, the surgery has been conventional perform the left atrial appendage closed surgery. However, surgical left atrial appendage ligation is difficult to be completely closed to the left atrial appendage,internal medicine intervention methods of surgical closure the left atrial appendage is relatively simple, minimally invasive, high success rate and is expected to be widely used. Several versions of LAA occlusion devices have been developed.LAA occluder of Lifetech consists of a umbrella, cover and conveyor; The umbrella composed of multiple umbrella and covered the ePTFE membrane.This study mainly evaluated the feasibility and safety of LAmbre Left Atrial Appendage Occluder! Through the femoral vein puncture; insert inter atrial septum puncture device; puncture a small hole in the atrial septal, delivery sheath is inserted in the femoral vein puncture site and across the atrial septal reach the left atrial appendage, establishment of the channel. Through the built-channel sent the LAA occluder to the left atrial appendage by the delivery cable; The LAA occlude will be fixed in the left atrial appendage, close the entrance of the left atrial appendage meanwhile and block blood flow; then eliminate the risk of blood clots due to atrial fibrillation, prevention stroke.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation, Stroke

Keywords

Atrial fibrillation, Thrombosis, Ischemic stroke, Left atrial appendage occluder, Intervention method

7. Study Design

Primary Purpose

Prevention

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Left Atrial Appendage Occluder

Arm Type

Experimental

Arm Description

Adopted non-comparative arm on Left Atrial Appendage Occluder.

Intervention Type

Device

Intervention Name(s)

LAmbre Left Atrial Appendage(LAA) Occluder

Intervention Description

Implanting the LAmbre Left Atrial Appendage Occluder to close the left atrial appendage

Primary Outcome Measure Information:

Title

The feasibility end-point

Description

Time Frame

30 days

Secondary Outcome Measure Information:

Title

The composite safety and efficacy end-point

Description

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient is ≥18 years of age; Chronic atrial fibrillation ≥3 months; paroxysmal, persistent or permanent non-valvular AF; CHADS2-VAS score 2 or higher; Patient can understand the trial purpose, voluntarily join this clinical trial with informed consent; Patient voluntarily completes the follow-up and follow-up inspection in accordance with the clinical trials process. Exclusion Criteria: A. Clinical exclusion criteria Presence of rheumatic, degenerative or congenital valvular heart diseases, The diameter of left atrial ≥65 mm; LAA size < 12mm or > 30 mm Left atrium has been removed; Heart transplantation patients; Symptomatic patients with carotid artery disease (such as carotid stenosis ≥ 50%); Acute myocardial infarction or unstable angina; Decompensated heart failure (New York Heart Association functional class III-IV); Recent myocardial infarction (< 3 months); Patients with an atrial septal defect or received an atrial septal occluder. The patient has an ablation procedure planned within 30 days of potential LAmbre Occluder implant The patient has a planned cardioversion 30 days post implant of the LAmbre Occluder Patient who after artificial mechanical heart valve replacement operation; Uncontrolled Heart rate ≥ 110 beats / min17) History stroke or TIA within 30 days; Presence of complex aortic plaque(4mm) in ascending aorta; Cardiac tumors or other malignancy with estimated life expectancy u less than 2 years; Have thrombocytopenia (platelet 《105 / μl) or anemia（Hb<10g/dl）; Women who is pregnancy or plan to pregnancy during the trial period; Presence of active sepsis or endocarditis; Patient participated in the other trials; The investigators expect the patient not be able to complete the trial according to requirements. B. Esophageal ultrasonic exclusion criteria LVEF≤30%; Presence of left atrial appendage thrombus; High risk PFO patients(presence of atrial septal aneurysm); Have obvious mitral valve stenosis (the area of mitral valve≤ 2 cm2); Have obvious and unexplained pericardial effusion(≥4 cm2). Presence of complex aortic plague(≥4 mm) in ascending aorta.

Overall Study Officials: