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

NCT01222156 | Unknown Phase 1 DMC

• 1 other identifier: CGCI HS01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tachycardia, Supraventricular; Tachycardia, Ventricular

Keywords

Cardiac arrhythmias; Catheter ablation; Electrophysiology; Magnetic; Mapping; Remote navigation

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (3)

• Intracardiac anatomic site target acquisition and repetition acquisition duration

  within 1 minute

• Pacing stimulation thresholds levels at the target intracardiac anatomic sites remotely and manually acquired

  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.

  within 1 minute

Study Arms (1)

CGCI navigation

EXPERIMENTAL

Subjects with CGCI navigation to specific target intracardiac anatomical sites

Procedure: Remote magnetic navigation; Device: Magnetecs Catheter Guidance Control and Imaging system

Interventions

Remote magnetic navigation PROCEDURE

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

Also known as: Magnetecs, CGCI

CGCI navigation

Magnetecs Catheter Guidance Control and Imaging system DEVICE

Magnetecs Catheter Guidance Control and Imaging (CGCI) system

CGCI navigation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are clinically eligible for catheter based therapy of cardiac arrhythmias
• Body Mass Index (BMI) \< 40
• Signed Informed Consent

You may not qualify if:

• Indication for atrial fibrillation ablation
• Indication for ischemic ventricular tachycardia ablation
• Severe cerebrovascular disease
• Serum creatinine \>2.5
• Active gastrointestinal bleeding
• Active infection or fever
• Short life expectancy (\<6 months)
• Severe uncontrolled systemic hypertension
• Severe electrolyte imbalance
• Congestive heart failure (NYHA Class IV)
• Unstable angina
• Recent MI (\<4 weeks)
• Bleeding or clotting disorders
• Uncontrolled diabetes
• Inability to receive IV Anticoagulants

Sponsors & Collaborators

• Magnetecs Corporation: lead

Study Sites (1)

Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

Related Links

• Sponsor website with information about the system and the trial

MeSH Terms

Conditions

Tachycardia, Supraventricular; Tachycardia, Ventricular; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Tachycardia; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jose L Merino, MD, PhD

  Hospital Universitario La Paz

  PRINCIPAL INVESTIGATOR

• Eli Gang, MD

  Magnetecs, Corp

  STUDY DIRECTOR

• Vivek Y Reddy, MD

  Mount Sinai Hospital, New York, USA

  STUDY CHAIR

Central Study Contacts

Kathy Tran

CONTACT

+1.310.6499000; kathy@engineeredmagnetics.net

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 14, 2010
• First Posted: October 18, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: October 18, 2010

Record last verified: 2010-10

Locations

ES (1)