Magnetic Resonance Imaging Guided Robotic Catheter System for Left Atrial Appendage Occlusion Procedures

Abstract
Atrial fibrillation is the most common form of cardiac arrhythmia, with prevalence estimated to be 5.2 million in
2010 and predicted to increase to 12.1 million in 2030. Atrial fibrillation is a major risk factor for blood clots and
stroke, independently increasing stroke risk 4- to 5-fold throughout all ages. Therefore, the vast majority of
patients with atrial fibrillation require some form of stroke prevention therapy. Current first line stroke prevention
therapy for atrial fibrillation patients is life-long use of oral anti-coagulation medications, which are associated
with increase in bleeding risk by approximately 2- to 2.5-fold, including intracranial hemorrhage, that may lead
to hospitalization, transfusion, surgery, and death.
The purpose of the present study is to improve stroke prevention treatment for non-valvular atrial fibrillation by
transforming the Left Atrial Appendage Occlusion (LAAO) procedure into a first line therapy for a larger segment
of patient populations, especially for younger patients with 20+ year of life expectancy who are likely to
experience bleeding problems in their lifetimes. LAAO is a minimally invasive procedure where an implant
delivered using an intravascular catheter is used to permanently seal off the left atrial appendage mechanically
to reduce the risk of blood clots. The barriers preventing LAAO from becoming a first line therapy are primarily
safety and cost. The investigators aim to overcome these barriers and transform LAAO into a first line therapy
by developing a real-time Magnetic Resonance Imaging (MRI)-guided robotic intravascular catheter system for
performing LAAO procedures by synergistically combining novel medical imaging, robotic catheter control, and
advanced visualization technologies to improve the safety, cost, and workflow of LAAO procedures.
The proposed technology expands on novel approaches initiated by the investigators in earlier work in the areas
of real-time MRI image acquisition and reconstruction, robotic catheters actuated using the magnetic field of the
MRI scanner, advanced visualization, and volumetric planning of LAAO. The project is organized into three
Specific Aims, each focusing on one key aspect of the procedure workflow, namely, procedure planning,
transseptal puncture, and LAAO implant delivery. These Specific Aims build on crosscutting technical research
on MRI, robotics, and human-machine interface technologies, where the investigators will develop novel
technologies for rapid and flexible 2D/3D cardiac MRI imaging, robotically controlled MRI-compatible dexterous
cardiac catheters, and human-machine interfaces with advanced visualization.
The end result of this proposal will be the complete prototype of an MRI-guided robotic catheter system for
performing LAAO procedures combining real-time intraoperative MRI, robotic catheter control, and advanced
visualization technologies to facilitate safer, more efficient, and cost-effective LAAO procedures. The developed
system and the underlying technologies will be validated by experts in interventional cardiology in vertebrate
animal and non-clinical human studies.

Grant Number: 5R01HL163991-04
NIH Institute/Center: NIH
Principal Investigator: M. Cenk Cavusoglu