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Related Concept Videos

Cardiac Catheterization III: Left Heart Catheterization01:24

Cardiac Catheterization III: Left Heart Catheterization

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Left heart catheterization is an invasive diagnostic procedure used to evaluate the function and structure of the left side of the heart. It is generally performed to diagnose and treat cardiovascular conditions such as valve abnormalities, coronary artery disease, and congenital heart defects.Diagnostic and therapeutic purposesLeft heart catheterization serves various diagnostic and therapeutic purposes, including:Assessing coronary artery bypass grafts.Evaluating coronary artery disease in...
268

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Related Experiment Video

Updated: Oct 14, 2025

The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
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Conformal Left Atrial Appendage Seal Device for Left Atrial Appendage Closure: First Clinical Use.

Robert J Sommer1, Jamie H Kim2, Molly Szerlip3

  • 1Columbia University Medical Center, NY, New York, USA.

JACC. Cardiovascular Interventions
|November 5, 2021
PubMed
Summary

The Conformal Left Atrial Appendage Seal (CLAAS) device shows early promise for left atrial appendage closure (LAAC) in high-stroke-risk patients. This initial study indicates clinical feasibility, with most patients achieving successful implantation and no major complications.

Keywords:
atrial fibrillationleft atrial appendage closureoral anticoagulant agentsstroke

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Area of Science:

  • Cardiology
  • Medical Devices
  • Interventional Procedures

Background:

  • First-generation left atrial appendage closure (LAAC) devices have limitations.
  • The Conformal Left Atrial Appendage Seal (CLAAS) device aims to overcome these limitations.
  • CLAAS is designed for minimally traumatic, noncoaxial deployment without requiring postprocedural oral anticoagulation.

Purpose of the Study:

  • To report the first clinical experience with the CLAAS device.
  • To evaluate the feasibility and safety of the CLAAS device for LAAC in patients with atrial fibrillation.
  • To assess device performance and procedural outcomes.

Main Methods:

  • Twenty-two high-stroke-risk patients (CHA2DS2-VASc score ≥2) with atrial fibrillation were enrolled.
  • The LAAC procedure involved transesophageal echocardiography guidance and general anesthesia.
  • The CLAAS device, featuring a foam cup with a Nitinol endoskeleton, was delivered via a standard system.

Main Results:

  • Successful implantation of the CLAAS device was achieved in 18 out of 22 patients.
  • No serious procedural complications were observed.
  • At 45 days, one significant leak and one device-related thrombus (resolved) were noted; no strokes or embolizations occurred.

Conclusions:

  • The first-in-human study demonstrates the clinical feasibility of the CLAAS device for LAAC.
  • The CLAAS device represents a potentially improved option for left atrial appendage closure.
  • Further investigation is warranted to confirm long-term efficacy and safety.