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Completed

NCT Number: NCT03147391

Left Atrial Appendage Closure With the LAmbre

The study was to retrospectively analyse the efficacy and safety of LAA closure using the LAmbre in our center from April 2014 to November 2015.

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Key information

About this study

The study was to retrospectively analyse the efficacy and safety of percutaneous left atrial appendage (LAA) closure using the LAmbre (Lifetech Scientific Co., Ltd., Shenzhen, China) in our center from April 2014 to November 2015. 89.4% has finished the 12-month esophageal ecllocardiogrhy (TEE) examination. The average followup was 2-years.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LAA closure with LAmbre

Device

Percutaneous Left Atrial Appendage Closure Using the LAmbre Device in Patients With Atrial Fibrillation

Primary outcomes

  1. Ischemic stroke

    Time frame: up to 5 years

    Ischemic stroke

Secondary outcomes

  1. The composite safety and efficacy end-points

    Time frame: up to 5 years

    all-cause death, stroke, major bleeding, thromboembolism, device related severe complications

  2. Successful sealing of the LAA

    Time frame: up to 5 years

    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 implantation

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Collaborators

  • Lifetech Scientific (Shenzhen) Co., Ltd.

Registry information

Official study title

Percutaneous Left Atrial Appendage Closure Using the LAmbre Device in Patients With Atrial Fibrillation: a Single-center, Retrospective, Long-term Real-world Study

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
May 10, 2017
Registry last updated
May 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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