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SecuraTM ICD Clinical Evaluation Study

This study is currently recruiting participants.
Verified by Medtronic Bakken Research Center, October 2007

Sponsored by: Medtronic Bakken Research Center
Information provided by: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT00526227
  Purpose

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 Intervention
Tachyarrhythmias
Device: Implantable Cardioverter Defibrillator

Genetics Home Reference related topics:   Brugada syndrome    short QT syndrome   

MedlinePlus related topics:   Pacemakers and Implantable Defibrillators   

ChemIDplus related topics:   Clotrimazole    Miconazole    Miconazole nitrate    Tioconazole   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:   Clinical Study to Evaluate System Safety and Clinical Performance of the SecuraTM ICD

Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • Confirm safety of the device by assessing the percentage of subjects with an unanticipated device effects at 1-month post implant. [ Time Frame: 1 month ]

Secondary Outcome Measures:
  • Summarize all harmful events (study related and non-study related) during the study and evaluate system performance [ Time Frame: 1 month ]

Estimated Enrollment:   80
Study Start Date:   October 2007
Estimated Study Completion Date:   April 2008

Arms Assigned Interventions
1: Experimental Device: Implantable Cardioverter Defibrillator
Implantable Cardioverter Defibrillator will be implanted

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
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00526227

Contacts
Contact: Secura Clinical Study Team     secura.brc@medtronic.com    

Locations
Germany
Hospital     Recruiting
      City, Germany
      Principal Investigator: Doctor Doctor            

Sponsors and Collaborators
Medtronic Bakken Research Center

Investigators
Study Chair:     Secura Clinical Study Team     Medtronic Bakken Research Center    
  More Information


Study ID Numbers:   111
First Received:   September 6, 2007
Last Updated:   October 30, 2007
ClinicalTrials.gov Identifier:   NCT00526227
Health Authority:   Sweden: Medical Products Agency;   Finland: National Agency for Medicines;   Netherlands: Dutch Health Care Inspectorate;   Germany: Federal Institute for Drugs and Medical Devices;   Austria: Federal Ministry for Health and Women;   Greece: Ministry of Health and Welfare;   Israel: Ministry of Health

Study placed in the following topic categories:
Heart Diseases
Clotrimazole
Miconazole
Tachycardia
Tioconazole
Arrhythmias, Cardiac

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 16, 2008




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