Accuracy and Safety Study of the Magnetecs CGCI System for Intracardiac Mapping

Tachycardia, Ventricular Clinical Trial

— RICTAM  

Official title:

Remote Intracardiac Catheter Target Acquisition Using the Magnetecs Catheter Guidance Control and Imaging (CGCI) System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01222156
• Other study ID #: CGCI HS01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: October 14, 2010
• Last updated: October 15, 2010
• Start date: October 2010
• Est. completion date: December 2010

Study information

• Verified date: October 2010
• Source: Magnetecs Corporation
• Contact: Kathy Tran
• Phone: +1.310.6499000
• Email: kathy[@]engineeredmagnetics.net
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Patients who are clinically eligible for catheter based therapy of cardiac arrhythmias

2. Body Mass Index (BMI) < 40

3. Signed Informed Consent

Exclusion Criteria:

1. Indication for atrial fibrillation ablation

2. Indication for ischemic ventricular tachycardia ablation

3. Severe cerebrovascular disease

4. Serum creatinine >2.5

5. Active gastrointestinal bleeding

6. Active infection or fever

7. Short life expectancy (<6 months)

8. Severe uncontrolled systemic hypertension

9. Severe electrolyte imbalance

10. Congestive heart failure (NYHA Class IV)

11. Unstable angina

12. Recent MI (<4 weeks)

13. Bleeding or clotting disorders

14. Uncontrolled diabetes

15. Inability to receive IV Anticoagulants

16. Presence of intracardiac thrombus

17. Patients with prosthetic cardiac valves

18. Patients with permanent pacemakers or ICD's

19. Pregnancy

20. Enrollment in any other ongoing clinical trial

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Supraventricular
• Tachycardia, Ventricular

Intervention

Procedure:
• Remote magnetic navigation
Remote magnetic navigation of electrophysiology catheters to target intracardiac anatomical sites at mapping-ablation procedures in patients with cardiac arrhythmias

Device:
• Magnetecs Catheter Guidance Control and Imaging system
Magnetecs Catheter Guidance Control and Imaging (CGCI) system

Locations

Country	Name	City	State
Spain	Hospital Universitario La Paz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Magnetecs Corporation

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intracardiac anatomic site target acquisition and repetition acquisition success rates	Intracardiac anatomic site target acquisition and repetition acquisition success rates of a mapping catheter remotely navigated by the Magnetecs CGCI system	within 1 minute	No
Primary	Serious adverse event rate	Serious adverse event rate at intracardiac anatomic site target acquisition of a mapping catheter remotely navigated by the Magnetecs CGCI system	within 7 days	Yes
Secondary	Intracardiac anatomic site target acquisition and repetition acquisition duration	Intracardiac anatomic site target acquisition and repetition acquisition duration of a mapping catheter remotely navigated by the Magnetecs CGCI system	within 1 minute	No
Secondary	Pacing stimulation thresholds levels at the target intracardiac anatomic sites remotely and manually acquired	Pacing stimulation thresholds levels at the target intracardiac anatomic sites remotely and manually acquired by the Magnetecs CGCI system and a conventional catheter manually operated respectively.	within 10 minutes	No
Secondary	Electrogram frequency spectrum and signal/noise levels at the target intracardiac anatomic sites remotely and manually acquired by the Magnetecs CGCI system and a conventional catheter manually operated respectively.	Electrogram frequency spectrum and signal/noise levels at the target intracardiac anatomic sites remotely and manually acquired by the Magnetecs CGCI system and a conventional catheter manually operated respectively.	within 1 minute	No

External Links

•   Sponsor website with information about the system and the trial