Research Updates: Electrophysiology Studies

Dr. Bruce Lindsay, MD

The Cleveland Clinic's electrophysiology (EP) group performs over a thousand AF ablation procedures annually, and has an unparalleled AF cure rate. To maintain our clinical advantage, AFIC's EP group is focused on: (1) advancing 3D imaging of the heart to improve ablation techniques; (2) testing and validating the newest and most promising catheter ablation tools in development, and (3) providing improved continuous monitoring of AF patients post ablation. Under the leadership of Dr. Andrea Natale and Jennifer Cummings, this group had developed close partnerships with a number of catheter, imaging, and monitoring companies, and has made good use of the new AFIC pre-clinical facilities in its research endeavors.

Merging 3D CT with electrocardiac mapping: The group has had a long-term interest in developing a novel image integration software package that can merge the various three-dimensional CT images of the cardiac chambers acquired before an ablation procedure with electroanatomical mapping data acquired during an ablation procedure. The group has partnered with Siemens to develop techniques of processing CT scan into 3D reconstructions. Siemens' system has now been successfully integrated into Biosense Webster's CARTO mapping system, and in to St. Jude's NAVX/ENSITE system. Biosense Webster played a major supporting role in the integration project. As a result of these efforts, ablation procedures will be substantially safer and easier to perform. We are hopeful that the AFIC labs will become an integral training site for the industry on this system.

CardioFocus laser balloon

Hansen robotic system control console

AFIC is also working with Siemens, using Siemens' Dyna CT C-arm system, to image moving tissues, such as a beating heart. Clinical investigation and evaluation of this system is expected to begin at the Cleveland Clinic in the fall of 2007.

Development of ablation catheters: AFIC is partnering with CardioFocus, Inc. to clinically test their laser balloon (see picture below), which has been designed to facilitate Pulmonary Vein Isolation (PVI) procedures. The AFIC labs are now the designated training facility for use of this new ablation tool.

AFIC is working with CryoCor, Inc. to test the company's cryoablation apparatus in the AFIC pre-clinical facilities. Results of these studies will be used by CryoCor to support an FDA application for product marketing approval.

Robotic Guidance System: AFIC has recently partnered with Hansen to be their dedicated training facility for their Sensi® robotic system that guides intra-cardiac catheters. The Sensi® system has recently received FDA approval, and the Cleveland Clinic was the first site to use the robotic system clinically.

Wireless Ambulatory Monitoring: AFIC is currently carrying out proof of principle experiments using Zin Technology's wireless remote monitors for post-op AF patients. Unlike the current standard (Holter monitors), the key feature of this monitor (other than being wireless) is that it can be programmed to measure a variety of physiological parameters – such parameters can be selected and set by the physician. This technology will enhance the acquisition, synchronization and correlation of physiological datasets that were previously very difficult to acquire.