SecuraTM ICD Clinical Evaluation Study
Information source: Medtronic Bakken Research Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tachyarrhythmias
Intervention: Implantable Cardioverter Defibrillator (Device)
Phase: N/A
Status: Completed
Sponsored by: Medtronic Bakken Research Center Official(s) and/or principal investigator(s): Secura Clinical Study Team, Study Chair, Affiliation: Medtronic Bakken Research Center
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: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Percentage of Subjects With an Unanticipated Serious Adverse Device Effects at 1-Month Post Implant.
Secondary outcome: Describe System PerformanceAdverse Events
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
Wels, Austria
Tampere, Finland
Goettingen, Germany
Hannover, Germany
Homburg/Saar, Germany
Kaiserslautern, Germany
Luedenscheid, Germany
Muenster, Germany
Athens, Greece
Breda, Netherlands
Enschede, Netherlands
Riyadh, Saudi Arabia
Lund, Sweden
Additional Information
Starting date: October 2007
Last updated: April 21, 2009
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