SecuraTM ICD Clinical Evaluation Study

Medtronic

Status

Completed

Conditions

Tachyarrhythmias

Treatments

Device: Secura ICD

Study type

Interventional

Funder types

Industry

Identifiers

NCT00526227

111

Details and patient eligibility

About

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)

Full 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.

Enrollment

81 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.