SecuraTM ICD Clinical Evaluation Study - Full Text View

Sponsor:	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

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

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Pacemakers and Implantable Defibrillators

U.S. FDA Resources

Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:

Percentage of Subjects With an Unanticipated Serious Adverse Device Effects at 1-Month Post Implant. [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Describe System Performance [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Adverse Events [ Time Frame: 1 Month ] [ Designated as safety issue: No ]

Enrollment:	81
Study Start Date:	October 2007
Study Completion Date:	October 2008
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Secura ICD implanted	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

Locations

Austria

Wels, Austria
Finland

Tampere, Finland
Germany

Kaiserslautern, Germany

Goettingen, Germany

Homburg/Saar, Germany

Luedenscheid, Germany

Hannover, Germany

Muenster, Germany
Greece

Athens, Greece
Netherlands

Enschede, Netherlands

Breda, 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

More Information

No publications provided

Study ID Numbers:	111
Study First Received:	September 6, 2007
Results First Received:	January 13, 2009
Last Updated:	April 21, 2009
ClinicalTrials.gov Identifier:	NCT00526227 History of Changes
Health Authority:	Sweden: Medical Products Agency; Finland: Finnish Medicines Agency; 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

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Tachycardia
Cardiovascular Diseases
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on February 08, 2010