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SecuraTM ICD Clinical Evaluation Study

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ClinicalTrials.gov Identifier: NCT00526227
Recruitment Status : Completed
First Posted : September 10, 2007
Results First Posted : June 10, 2009
Last Update Posted : June 10, 2009
Sponsor:
Information provided by:
Medtronic Bakken Research Center

Brief 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)

Condition or disease Intervention/treatment Phase
Tachyarrhythmias Device: Implantable Cardioverter Defibrillator Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study to Evaluate System Safety and Clinical Performance of the SecuraTM ICD
Study Start Date : October 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Secura ICD implanted
Device: Implantable Cardioverter Defibrillator
Implantable Cardioverter Defibrillator will be implanted
Other Name: Secura TM



Primary Outcome Measures :
  1. Percentage of Subjects With an Unanticipated Serious Adverse Device Effects at 1-Month Post Implant. [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Describe System Performance [ Time Frame: 1 month ]
  2. Adverse Events [ Time Frame: 1 Month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00526227


Locations
Austria
Wels, Austria
Finland
Tampere, Finland
Germany
Goettingen, Germany
Hannover, Germany
Homburg/Saar, Germany
Kaiserslautern, Germany
Luedenscheid, Germany
Muenster, Germany
Greece
Athens, Greece
Netherlands
Breda, Netherlands
Enschede, Netherlands
Saudi Arabia
Riyadh, Saudi Arabia
Sweden
Lund, Sweden
Sponsors and Collaborators
Medtronic Bakken Research Center
Investigators
Study Chair: Secura Clinical Study Team Medtronic Bakken Research Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00526227     History of Changes
Other Study ID Numbers: 111
First Posted: September 10, 2007    Key Record Dates
Results First Posted: June 10, 2009
Last Update Posted: June 10, 2009
Last Verified: April 2009

Additional relevant MeSH terms:
Tachycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes