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

Launched by MAGNETECS CORPORATION · Oct 15, 2010

Keywords

ClinConnect Summary

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 di...

Gender

ALL

Eligibility 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