SecuraTM ICD Clinical Evaluation Study

Clinical Study to Evaluate System Safety and Clinical Performance of the SecuraTM ICD

NCT00526227•Medtronic Cardiac Rhythm and Heart Failure

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)

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

Age

18 - No limit years

Sex

ALL

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.

Locations (13)

Wels, Austria

Tampere, Finland

Goettigen, Germany

Hanover, Germany

Homburg/Saar, Germany

Kaiserslautern, Germany

Lüdenscheid, Germany

Münster, Germany

Athens, Greece

Breda, Netherlands

Key Dates

Start Date

October 1, 2007

Primary Completion Date

December 1, 2007

Completion Date

October 1, 2008

Last Updated

July 2, 2025

Enrollment

ACTUAL participants

Conditions

Tachyarrhythmias

Interventions

Secura ICD

DEVICE

Botulinum Toxin Injection for Preventing Secondary Atrial Fibrillation in Patient With Supra-ventricular Tachyarrythmias

NCT02008461

Supra-ventricular Tachyarrhythmias

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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