Status:
UNKNOWN
Accuracy and Safety Study of the Magnetecs CGCI System for Intracardiac Mapping
Lead Sponsor:
Magnetecs Corporation
Conditions:
Tachycardia, Supraventricular
Tachycardia, Ventricular
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
PHASE2
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 ...
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. ...
Eligibility Criteria
Inclusion
- Patients who are clinically eligible for catheter based therapy of cardiac arrhythmias
- Body Mass Index (BMI) \< 40
- Signed Informed Consent
Exclusion
- 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
- Presence of intracardiac thrombus
- Patients with prosthetic cardiac valves
- Patients with permanent pacemakers or ICD's
- Pregnancy
- Enrollment in any other ongoing clinical trial
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01222156
Start Date
October 1 2010
End Date
December 1 2010
Last Update
October 18 2010
Active Locations (1)
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1
Hospital Universitario La Paz
Madrid, Spain, 28046