Tachycardia, Ventricular Clinical Trial
— RICTAMOfficial title:
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 2010 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario La Paz | Madrid |
Lead Sponsor | Collaborator |
---|---|
Magnetecs Corporation |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | 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 | Yes |
Secondary | Intracardiac anatomic site target acquisition and repetition acquisition duration | Intracardiac anatomic site target acquisition and repetition acquisition duration of a mapping catheter remotely navigated by the Magnetecs CGCI system | within 1 minute | No |
Secondary | Pacing stimulation thresholds levels at the target intracardiac anatomic sites remotely and manually acquired | 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 | No |
Secondary | 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. | 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 | No |
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