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Completed

NCT Number: NCT00526227

SecuraTM ICD Clinical Evaluation Study

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)

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Key information

Conditions

Tachyarrhythmias Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wels, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Secura ICD

Device

Secura Implantable Cardioverter Defibrillator (ICD) will be implanted

Other names: Secura TM

Primary outcomes

  1. Freedom From Unanticipated Serious Adverse Device Effects at 1-month Post Implant.

    Time frame: 1 month

    Criteria to assess the results of the primary objective safety analysis is to demonstrate that the percentage of subjects experiencing an Unanticipated Serious Adverse Device Effect (USADE) is lower than 10% at one-month post-implant, with one month considered to be the same as 28 days.

    A pre-specified interim analysis is included in the study which, if the primary objective was met, is to also be considered the final analysis.

Secondary outcomes

  1. System Performance Assessed by Holter Records

    Time frame: 1 month

    The first 21 digital Holter records that were successfully collected in the total of 80 implanted participants will summarize any anomalous or unintended operation and describe device features, ventricular arrhythmia detection times and device classification of ventricular arrhythmias.

  2. Adverse Events

    Time frame: 1 Month

    Number of Adverse Events reported in the implanted subjects.

  3. System Performance Assessed by Save to Disk Files

    Time frame: 1 month follow-up

    The Save to Disk files from 79 implanted participants collected after implant and 1 month follow up were reviewed to identify any anomolous or unintended device operation, examine device features, observe ventricular arrhythmia detection times and device classification of ventricular arrhythmias.

  4. System Performance Assessed by Technical Observations

    Time frame: 1 month follow-up

    Reported technical observations will be reviewed to determine if there are any device performance issues.

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2008
First posted
Sep 10, 2007
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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