DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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 Performance

Adverse 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017