Tachycardia, Ventricular Clinical Trial
Official title:
Remote Intracardiac Catheter Target Acquisition Using the Magnetecs Catheter Guidance Control and Imaging (CGCI) System
The Magnetecs Catheter Guidance Control and Imaging (CGCI) system is a magnetic remote
navigation system which is comprised of a magnetic chamber of eight electromagnets around
the patient torso. The system can change the magnetic field almost instantaneously and
enables almost real time manipulation of a special magnetic catheter (Maxwell mapping
catheter) which results in accurate, repeatable, rapid and safe target acquisition within
the four chambers of the human heart.
The trial is a prospective, non-randomized, clinical one designed to test the study
hypotheses of (a) technical equivalence of the study device in comparison to other magnetic
remote navigation systems, (b) performance equivalence or non-inferiority of the study
device target acquisition capability compared to presently used catheter navigation
techniques, and (c) safety equivalence or non-inferiority of the study device in comparison
to catheter navigation devices using other navigation techniques.
The CGCI system is comprised of (a) magnetic chamber of eight electromagnets around the
patient torso, (b) the Maxwell ©, a 7Fr. Inquiry™ catheter with an attached magnetic pellet
manufactured by St. Jude Medical, Inc. The Maxwell © is equivalent to a 7 Fr. Inquiry™
cleared under 510(K) K022380, and (c) a Agilis ES Active Sheath© which is a modified 7.5 Fr.
Steerable Introducer is equivalent to the Agilis NxT™ Steerable Introducer, manufactured by
St. Jude Medical, Inc. and cleared under 510(K) K061363.
Study Rationale: Current manual manipulations of mapping catheters are imprecise and
difficult to control. The Magnetecs CGCI system enables almost real time manipulation of the
Maxwell mapping catheter which results in accurate, repeatable, rapid and safe target
acquisition. The CGCI System is intended to navigate a magnetic catheter within the four
chambers of the human heart by orienting and moving the catheter tip to designated
anatomically significant targets.
Design: A prospective, non-randomized, clinical trial designed to test the study hypotheses
of (a) technical equivalence of the study device in comparison to other magnetic remote
navigation systems, (b) performance equivalence or non-inferiority of the study device
target acquisition capability compared to presently used catheter navigation techniques, and
(c) safety equivalence or non-inferiority of the study device in comparison to catheter
navigation devices using other navigation techniques.
Target Population:Patients who have recurrent cardiac rhythm disturbances and who meet
clinically recognized indications for performance of an intracardiac mapping procedure.
Planned Number of Subjects: A total of 40 patients
Study Objectives: This study is designed to collect data to test the target acquisition
performance efficacy and safety of the CGCI for intracardiac navigation.
The objective is to achieve the navigation performance criteria for the primary efficacy
endpoints for reaching preselected anatomically significant targets in the right and left
heart chambers, respectively. The secondary efficacy endpoints are obtained by measurements
of stimulation thresholds at selected anatomic sites, and by analyzing surface and
intracardiac signal recordings during target acquisition with the CGCI magnetic system.
The primary safety endpoints are defined as the rate of procedure related incidence of
serious acute Adverse Events due to manipulation of the magnetic catheter. Verification of
these adverse events will be by fluoroscopy, echocardiograms and physician observations, and
the results will be subjected to statistical evaluation.
The claims of substantial technical equivalence to other magnetic remote navigation systems
will be verified by collecting data at the outset of each clinical procedure, measuring
maximum magnetic field strength at the center region and around the outside perimeter of the
CGCI device, and by measuring the maximum force available at the catheter tip.
Success will be evaluated in accordance with the primary efficacy and safety endpoint
specifications, and by the technical equivalency tests. Data collection and sample size are
defined to comply with FDA (1992) 80/20 ruling to adequately power the hypothesis tests.
Investigational Site: Hospital Universitario La Paz P. Castellana, 216. 28046 Madrid, Spain
Tel/ Fax: + 34 917277564
Participating Physicians: Dr. Jose Luis Merino, Dr. Vivek Reddy, Dr. Eli Gang, Dr. Armando
Perez Silva, Dr. Sara Moreno Reviriego, Dr. Sergio Castrejon, Dr. Alejandro Estrada, Dr.
David Doiny, Dr. Bich-Lien Nguyen, Dr. Petr Neuzil, Dr. Andre D'Avila.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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