Feasibility and Safety Study of LAmbre Left Atrial Appendage Occluder

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

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).

Study Overview

• Status: Completed
• Conditions: Stroke; Atrial Fibrillation
• Intervention / Treatment: Device: LAmbre Left Atrial Appendage(LAA) Occluder

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Hong Kong, China
    • Prince of Wales Hospital

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:

1. Patient is ≥18 years of age;
2. Chronic atrial fibrillation ≥3 months; paroxysmal, persistent or permanent non-valvular AF;
3. CHADS2-VAS score 2 or higher;
4. Patient can understand the trial purpose, voluntarily join this clinical trial with informed consent;
5. 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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Left Atrial Appendage Occluder; Adopted non-comparative arm on Left Atrial Appendage Occluder.	Device: LAmbre Left Atrial Appendage(LAA) Occluder; Implanting the LAmbre Left Atrial Appendage Occluder to close the left atrial appendage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Collaborators and Investigators

• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
• Investigators: Principal Investigator: Yat-Yin YY Lam, MD, Prince of Wales Hospital, Shatin, Hong Kong; Principal Investigator: Muhammad Munawar, MD, Binawaluya Hospital, Indonesia; Principal Investigator: Lan Hieu Nguyen, MD, Hanoi Heart Hospital, Vietnam; Principal Investigator: Yan Yao, MD, Chinese Academy of Medical Sciences, Fuwai Hospital; Principal Investigator: Congxin Huang, MD, Renmin Hospital of Wuhan University,China

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: August 8, 2013
• First Submitted That Met QC Criteria: August 8, 2013
• First Posted (Estimate): August 12, 2013

Study Record Updates

• Last Update Posted (Actual): August 7, 2018
• Last Update Submitted That Met QC Criteria: August 6, 2018
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Thrombosis; Ischemic stroke; Left atrial appendage occluder; Intervention method
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: LA-AP-01