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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Magnetecs Corporation.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Magnetecs Corporation
ClinicalTrials.gov Identifier:
NCT01222156
First received: October 14, 2010
Last updated: October 15, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention Phase
Tachycardia, Supraventricular
Tachycardia, Ventricular
Procedure: Remote magnetic navigation
Device: Magnetecs Catheter Guidance Control and Imaging system
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Remote Intracardiac Catheter Target Acquisition Using the Magnetecs Catheter Guidance Control and Imaging (CGCI) System

Resource links provided by NLM:


Further study details as provided by Magnetecs Corporation:

Primary Outcome Measures:
  • Intracardiac anatomic site target acquisition and repetition acquisition success rates [ Time Frame: within 1 minute ] [ Designated as safety issue: No ]
    Intracardiac anatomic site target acquisition and repetition acquisition success rates of a mapping catheter remotely navigated by the Magnetecs CGCI system

  • Serious adverse event rate [ Time Frame: within 7 days ] [ Designated as safety issue: Yes ]
    Serious adverse event rate at intracardiac anatomic site target acquisition of a mapping catheter remotely navigated by the Magnetecs CGCI system


Secondary Outcome Measures:
  • Intracardiac anatomic site target acquisition and repetition acquisition duration [ Time Frame: within 1 minute ] [ Designated as safety issue: No ]
    Intracardiac anatomic site target acquisition and repetition acquisition duration of a mapping catheter remotely navigated by the Magnetecs CGCI system

  • Pacing stimulation thresholds levels at the target intracardiac anatomic sites remotely and manually acquired [ Time Frame: within 10 minutes ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: October 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01222156

Contacts
Contact: Kathy Tran +1.310.6499000 kathy@engineeredmagnetics.net

Locations
Spain
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Contact: Jose L Merino, MD, PhD    +34917277564    jlmerino@arritmias.net   
Contact: Maria J Diaz-Pintado    +34917277564    mjdvergara@arritmias.net   
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         
Sponsors and Collaborators
Magnetecs Corporation
Investigators
Principal Investigator: Jose L Merino, MD, PhD Hospital Universitario La Paz, Madrid (Spain)
Study Director: Eli Gang, MD Magnetecs, Corp
Study Chair: Vivek Y Reddy, MD Mount Sinai Hospital, New York, USA
  More Information

Additional Information:
No publications provided

Responsible Party: Josh Sachar/CEO and Chief Technology Officer, Magnetecs, Corp
ClinicalTrials.gov Identifier: NCT01222156     History of Changes
Other Study ID Numbers: CGCI HS01
Study First Received: October 14, 2010
Last Updated: October 15, 2010
Health Authority: Spain: Ministry of Health

Keywords provided by Magnetecs Corporation:
Cardiac arrhythmias
Catheter ablation
Electrophysiology
Magnetic
Mapping
Remote navigation

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Supraventricular
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014