Accuracy and Safety Study of the Magnetecs CGCI System for Intracardiac Mapping
NCT ID: NCT01222156
Last Updated: 2010-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2010-10-31
2010-12-31
Brief Summary
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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.
Detailed Description
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Study Rationale: Current manual manipulations of mapping catheters are imprecise and difficult to control. The Magnetecs CGCI system enables almost real time manipulation of the Maxwell mapping catheter which results in accurate, repeatable, rapid and safe target acquisition. The CGCI System is intended to navigate a magnetic catheter within the four chambers of the human heart by orienting and moving the catheter tip to designated anatomically significant targets.
Design: A prospective, non-randomized, clinical trial 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.
Target Population:Patients who have recurrent cardiac rhythm disturbances and who meet clinically recognized indications for performance of an intracardiac mapping procedure.
Planned Number of Subjects: A total of 40 patients
Study Objectives: This study is designed to collect data to test the target acquisition performance efficacy and safety of the CGCI for intracardiac navigation.
The objective is to achieve the navigation performance criteria for the primary efficacy endpoints for reaching preselected anatomically significant targets in the right and left heart chambers, respectively. The secondary efficacy endpoints are obtained by measurements of stimulation thresholds at selected anatomic sites, and by analyzing surface and intracardiac signal recordings during target acquisition with the CGCI magnetic system.
The primary safety endpoints are defined as the rate of procedure related incidence of serious acute Adverse Events due to manipulation of the magnetic catheter. Verification of these adverse events will be by fluoroscopy, echocardiograms and physician observations, and the results will be subjected to statistical evaluation.
The claims of substantial technical equivalence to other magnetic remote navigation systems will be verified by collecting data at the outset of each clinical procedure, measuring maximum magnetic field strength at the center region and around the outside perimeter of the CGCI device, and by measuring the maximum force available at the catheter tip.
Success will be evaluated in accordance with the primary efficacy and safety endpoint specifications, and by the technical equivalency tests. Data collection and sample size are defined to comply with FDA (1992) 80/20 ruling to adequately power the hypothesis tests.
Investigational Site: Hospital Universitario La Paz P. Castellana, 216. 28046 Madrid, Spain Tel/ Fax: + 34 917277564
Participating Physicians: Dr. Jose Luis Merino, Dr. Vivek Reddy, Dr. Eli Gang, Dr. Armando Perez Silva, Dr. Sara Moreno Reviriego, Dr. Sergio Castrejon, Dr. Alejandro Estrada, Dr. David Doiny, Dr. Bich-Lien Nguyen, Dr. Petr Neuzil, Dr. Andre D'Avila.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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CGCI navigation
Subjects with CGCI navigation to specific target intracardiac anatomical sites
Remote magnetic navigation
Remote magnetic navigation of electrophysiology catheters to target intracardiac anatomical sites at mapping-ablation procedures in patients with cardiac arrhythmias
Magnetecs Catheter Guidance Control and Imaging system
Magnetecs Catheter Guidance Control and Imaging (CGCI) system
Interventions
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Remote magnetic navigation
Remote magnetic navigation of electrophysiology catheters to target intracardiac anatomical sites at mapping-ablation procedures in patients with cardiac arrhythmias
Magnetecs Catheter Guidance Control and Imaging system
Magnetecs Catheter Guidance Control and Imaging (CGCI) system
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Body Mass Index (BMI) \< 40
3. Signed Informed Consent
Exclusion Criteria
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
18 Years
85 Years
ALL
No
Sponsors
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Magnetecs Corporation
OTHER
Responsible Party
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Magnetecs, Corp
Principal Investigators
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Jose L Merino, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario La Paz
Eli Gang, MD
Role: STUDY_DIRECTOR
Magnetecs, Corp
Vivek Y Reddy, MD
Role: STUDY_CHAIR
Mount Sinai Hospital, New York, USA
Locations
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Hospital Universitario La Paz
Madrid, , Spain
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Sponsor website with information about the system and the trial
Other Identifiers
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CGCI HS01
Identifier Type: -
Identifier Source: org_study_id