SecuraTM ICD Clinical Evaluation Study
Information source: Medtronic Bakken Research Center
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tachyarrhythmias
Intervention: Implantable Cardioverter Defibrillator (Device)
Phase: N/A
Status: Recruiting
Sponsored by: Medtronic Bakken Research Center Official(s) and/or principal investigator(s):
Secura Clinical Study Team, Study Chair, Affiliation: Medtronic Bakken Research Center
Overall contact:
Secura Clinical Study Team, Email: secura.brc@medtronic.com
Summary
The purpose of the Secura clinical study is to evaluate the overall system safety and
clinical performance of the Secura DR Implantable Cardioverter Defibrillator (ICD)
Clinical Details
Official title: Clinical Study to Evaluate System Safety and Clinical Performance of the SecuraTM ICD
Study design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Primary outcome: Confirm safety of the device by assessing the percentage of subjects with an unanticipated device effects at 1-month post implant.
Secondary outcome: Summarize all harmful events (study related and non-study related) during the study and evaluate system performance
Detailed description:
The Secura ICD is an investigational dual chamber ICD that provides atrial and ventricular
tachyarrhythmia detection and therapy, cardioversion, defibrillation, dual chamber
rate-responsive bradycardia pacing and diagnostics.
The study will be a prospective, non-randomized, multicenter clinical study, conducted in
approximately 15 centers.
To allow for sufficient experience with the device, a maximum of 80 subjects may be implanted
with the Secura device. Data will be collected at baseline (enrollment), implant, 1-, 3-, and
6- months post implant and every 6 months thereafter or until study closure (whichever occurs
first), unscheduled follow-up visits, System Modifications, Technical Observations, Study
Deviations, Study Exit, upon notification of new or updated Adverse Events and in case of
death.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients who have an ICD indication.
- Patients who are geographically stable and available for follow-up at the study center
for the duration of the study.
- Patients who have signed a Medical Ethics Committee (MEC) approved Informed Consent
form.
Exclusion Criteria:
- Patients with a life expectancy less than the duration of the study.
- Patients with medical conditions that preclude the testing required for all patients
by the study protocol or that otherwise limit study participation required for all
patients.
- Patients with mechanical tricuspid heart valves.
Locations and Contacts
Secura Clinical Study Team, Email: secura.brc@medtronic.com
Hospital, City, Germany; Recruiting
Doctor Doctor, Principal Investigator
Additional Information
Starting date: October 2007
Ending date: April 2008
Last updated: October 30, 2007
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