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Status:

COMPLETED

LAMax Vs. Watchman LAAC Device for Subjects With Non-valvular AF to Reduce the Risk of Stroke

Lead Sponsor:

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborating Sponsors:

The Third Medical Center, Chinese People's Liberation Army General Hospital

The Second Affiliated Hospital of Chongqing Medical University

Conditions:

Non-valvular Atrial Fibrillation

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

This is a prospective, multicenter, randomized, active controlled, clinical trial to evaluate the safety and effectiveness of the LAMax Left Atrial Appendage (LAA) Closure System.

Detailed Description

This is a prospective, multicenter, randomized, active controlled, clinical trial to evaluate the safety and effectiveness of the LAMax Left Atrial Appendage Closure (LAAC) System. Subjects with non-v...

Eligibility Criteria

Inclusion

  • Patients ≥ 18 years old with non-valvular atrial fibrillation (AF) and CHA2DS2-VASc ≥2
  • There is one of the following: (1) Not suitable for long-term standard anticoagulation treatment; (2) On the basis of long-term standardized anticoagulant therapy with warfarin, stroke or embolism still occurred; (3) HAS-BLED ≥ 3.
  • Provide written informed consent and agree to comply with required follow-ups.

Exclusion

  • . Patients with other diseases other than AF who need long-term warfarin anticoagulation therapy;
  • . Those who need selective cardiac surgery;
  • . Heart failure NYHA grade IV;
  • . AF caused by rheumatic valvular disease, degenerative valvular disease, congenital valvular disease, severe mitral stenosis, aortic stenosis, or other valvular diseases;
  • . The early onset of AF and paroxysmal AF with definite causes, such as secondary to coronary artery bypass grafting (CABG), hyperthyroidism;
  • . Patients with symptomatic carotid artery disease (such as carotid stenosis \> 50%);
  • . Patients with acute myocardial infarction, unstable angina, or recent myocardial infarction \< 3 months;
  • . Stroke or TIA within 30 days;
  • . Bleeding disease, coagulation-related diseases, and active peptic ulcer;
  • . Active endocarditis, vegetations, or other infections causing bacteremia or sepsis;
  • . Conditions may lead to difficulty in testing or significantly shorten the life expectancy of patients (\< 1 year);
  • . Pregnant, lactating or planned pregnancy during the trial;
  • . Patients who have not reached the end of other clinical trials of drug or device;
  • . Hematological abnormality (WBC \< 3 × 109 / L, HB \< 90g / L, or platelet count \< 50 × 109 / L or \> 700 × 109 / L));
  • . Renal insufficiency (creatinine \> 3.0mg/dl or 265.2umoi / L), and / or advanced renal diseases requiring dialysis;
  • . Severe liver dysfunction (AST / ALT is 5 times higher than the upper limit of normal value, or total bilirubin is 2 times higher than the upper limit of normal value);
  • . The investigator believes that the patient is not suitable to participate in the clinical trial.
  • . Left atrial appendage has been removed, post heart transplantation, post atrial septal repair, or post occluder implantation;
  • . Radiofrequency ablation in 30 days before and after the implantation of LAA occluder;
  • . Cardioversion within 30 days after the implantation of LAA occluder;
  • . Post prosthetic heart valve replacement;
  • . Allergic to or contraindication to metal nickel alloy, aspirin, clopidogrel, contrast agent, heparin and other anticoagulants, etc;
  • . Patients who have placed other instruments in the cardiovascular cavity and are unable to place the LAA occluder;
  • . LVEF（left ventricular ejection fraction ）\<35%；
  • . Clear thrombus is found in the heart before device implantation;
  • . TEE examination: refer to Watchman LAAC requirement to measure the orifice diameter of LAA, the maximum diameter is less than 17 mm, or more than 31 mm;
  • . Patent foramen ovale with high risk;
  • . mitral stenosis with a valve area ≤ 2 cm2;
  • . left atrial diameter \> 65mm, or pericardial effusion more than a small amount, the depth of local effusion \> 10 mm;
  • . Contraindications to X-ray, or not suitable for TEE examination.

Key Trial Info

Start Date :

April 20 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 10 2021

Estimated Enrollment :

236 Patients enrolled

Trial Details

Trial ID

NCT04429646

Start Date

April 20 2019

End Date

June 10 2021

Last Update

May 6 2022

Active Locations (12)

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Page 1 of 3 (12 locations)

1

The First Hospital of Lanzhou University

Lanzhou, Gansu, China, 730000

2

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China, 050003

3

Ganzhou Municipal Hospital

Ganzhou, Jiangxi, China, 341001

4

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China, 330000