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

October 15, 2010 updated by: Magnetecs Corporation

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jose L Merino, MD, PhD
        • Sub-Investigator:
          • Sergio Castrejon, MD
        • Sub-Investigator:
          • Armando Perez-Silva, MD
        • Sub-Investigator:
          • David Doiny, MD
        • Sub-Investigator:
          • Alejandro Estrada, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CGCI navigation
Subjects with CGCI navigation to specific target intracardiac anatomical sites
Procedure: Remote magnetic navigation
Remote magnetic navigation of electrophysiology catheters to target intracardiac anatomical sites at mapping-ablation procedures in patients with cardiac arrhythmias
Other Names:
  • Magnetecs
  • CGCI
Device: Magnetecs Catheter Guidance Control and Imaging system
Magnetecs Catheter Guidance Control and Imaging (CGCI) system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intracardiac anatomic site target acquisition and repetition acquisition success rates
Time Frame: within 1 minute
Intracardiac anatomic site target acquisition and repetition acquisition success rates of a mapping catheter remotely navigated by the Magnetecs CGCI system
within 1 minute
Serious adverse event rate
Time Frame: within 7 days
Serious adverse event rate at intracardiac anatomic site target acquisition of a mapping catheter remotely navigated by the Magnetecs CGCI system
within 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intracardiac anatomic site target acquisition and repetition acquisition duration
Time Frame: within 1 minute
Intracardiac anatomic site target acquisition and repetition acquisition duration of a mapping catheter remotely navigated by the Magnetecs CGCI system
within 1 minute
Pacing stimulation thresholds levels at the target intracardiac anatomic sites remotely and manually acquired
Time Frame: within 10 minutes
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
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.
Time Frame: within 1 minute
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Magnetecs Corporation

Investigators

  • Principal Investigator: Jose L Merino, MD, PhD, Hospital Universitario La Paz
  • Study Director: Eli Gang, MD, Magnetecs, Corp
  • Study Chair: Vivek Y Reddy, MD, Mount Sinai Hospital, New York, USA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

October 14, 2010

First Submitted That Met QC Criteria

October 15, 2010

First Posted (Estimate)

October 18, 2010

Study Record Updates

Last Update Posted (Estimate)

October 18, 2010

Last Update Submitted That Met QC Criteria

October 15, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CGCI HS01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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